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WO2013072701A1 - Dispositif, programme et procédé de traitement par rayonnement lumineux - Google Patents

Dispositif, programme et procédé de traitement par rayonnement lumineux Download PDF

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Publication number
WO2013072701A1
WO2013072701A1 PCT/GB2012/052852 GB2012052852W WO2013072701A1 WO 2013072701 A1 WO2013072701 A1 WO 2013072701A1 GB 2012052852 W GB2012052852 W GB 2012052852W WO 2013072701 A1 WO2013072701 A1 WO 2013072701A1
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Prior art keywords
light
light irradiation
patient
package
wavelength
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English (en)
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Peter Gruenewald
Graeme PENHORWOOD
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VIORED Ltd
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VIORED Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0619—Acupuncture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0622—Optical stimulation for exciting neural tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0645—Applicators worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/065—Light sources therefor
    • A61N2005/0651—Diodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0662—Visible light
    • A61N2005/0663—Coloured light

Definitions

  • This invention relates to devices for the treatment of patients by light irradiation, as well as programs for controlling light irradiation, and methods of light irradiation.
  • LLLT low level laser therapy
  • the irradiation may be intravenous (i.e. direct irradiation of the blood) and/or percutaneous (i.e. through the skin) and usually has a wavelength in the red or infrared region of the spectrum.
  • LLLT has been used in the treatment of conditions including cardiovascular disease, diabetes, hypertension and occlusive vascular diseases.
  • Light therapies have also been used to alleviate symptoms of arthritis as well as depressive illnesses such as seasonal affective disorder.
  • LLLT increases cell synthesis of ATP, leading to increased metabolic activity and thus the stimulation of cell repair processes amongst other effects. It is the ability of radiation to modify biochemical mechanisms occurring in body tissue, such as this, which leads to the treatment's effectiveness.
  • HRV heart rate variability
  • a high HRV is a sign of good health and youthfulness of the organism, reflecting their good adaptability. In contrast, HRV decreases with advancing age and poor health.
  • Another relevant parameter is the degree of order of the patient's HRV, usually referred to as "coherence”: a highly rhythmic HRV with strong periodicity (e.g. a substantially sinusoidal variation over time) is indicative of good health. Low coherence, where the HRV is disordered, occurs with advancing age, poor health and when experiencing stress.
  • LF low frequencies
  • HF high frequencies
  • HRV heart's electrical activity
  • LF Low frequencies
  • HF high frequencies
  • High amplitudes across the frequency spectrum are thus indicative of a high HRV (in terms of its SDNN) and hence reflect good health.
  • the level of activity across all frequencies generally decreases with age.
  • the ratio of low to high frequencies (“LF/HF” ratio) over 24 hours is also related to health of the organism, although the optimum ratio is age-dependent.
  • Improving a person's HRV (in terms of SDNN and/or coherence and/or exhibited frequencies) therefore leads to a range of benefits - which may be therapeutic or non-therapeutic -including for example an increased ability to deal with stress, rejuvenation, increased energy, increased mental and physical performance, and assistance in recovery from chronic diseases such as but not limited to MS, ME, fatigue and heart conditions.
  • An aim of the present invention is to provide a means for improving a patent's HRV (in terms of any or all of the above-mentioned parameters) by conditioning the body through light irradiation.
  • a device for the treatment of a patient by light irradiation comprises:
  • a radiation emitter assembly controllable to emit light at each of first, second and third wavelengths, sequentially;
  • an energy source arranged to supply power to the radiation emitter assembly
  • a controller adapted to actuate the radiation emitter assembly to output a light irradiation sequence of three or more sequential light packages, wherein the or each light package is output by emitting light at one of the first, second and third wavelengths for a period of time, the light irradiation sequence including at least one light package of the first wavelength, at least one light package of the second wavelength and at least one light package of the third wavelength, and wherein the light irradiation sequence comprises at least one delay period between light packages, during which no radiation is emitted.
  • the present inventors have found that light irradiation can be used to influence or "entrain" a patient's autonomic nervous system, which regulates organ functions and hence in turn can lead to an improvement in HRV, in terms of SDNN, coherence, total frequency amplitude (power) and/or improved LF/HF ratio. Further, the insertion of one or more delays or "neutral" intervals into the irradiation sequence unexpectedly amplifies the biostimulative effect of the light irradiation.
  • the autonomic nervous system (ANS) is subdivided into two parts with opposite and complementary functions: the sympathetic nervous system and the parasympathetic (vagal) nervous system.
  • the sympathetic nervous system promotes mobilising of energy and encourages:
  • the parasympathetic nervous system encourages rest and recovery, enhancing: befriending and nurturing;
  • the various physiological processes that are regulated by the ANS each give rise to a body rhythm which is reflected in the electric activity of the patient's heart.
  • Analysis of the heart's electrical activity reveals distinct frequency components which can each be attributed to the various physiological rhythms.
  • sympathetic activities are identified as "low frequency” components, and range between 0.04 and 0.15 Hz.
  • blood pressure variations typically have a frequency of around 0.1 Hz.
  • Parasympathetic activities are associated predominantly with "high frequencies” ranging between 0.15 to 0.4 Hz.
  • a typical respiration rhythm has a frequency around 0.28 Hz.
  • the frequency components can be studied by performing a HRV (frequency domain) power spectrum analysis of the heart's electrical output, measured for example using an electrocardiogram ("ECG").
  • HRV frequency domain
  • ECG electrocardiogram
  • Various different methods of performing the power spectrum analysis are known, and are available as software packages such as the EmWave® package supplied by HeartMath LLC, many of which are based on a fast Fourier transform.
  • An example power spectrum is shown in Figure 1. This depicts the amplitude (power) of each different frequency in the electrical activity of the heart over a 25 hour period and thereby gives a precise window into the functioning of the autonomic nervous system (ANS).
  • ANS autonomic nervous system
  • the power spectrum analysis has been performed with the ChronoCord product, by HumanResearch of Austria.
  • the power level of each frequency (identified on the y-axis) is represented by the displayed colour.
  • the brightest regions are indicative of high power, whereas the darkest regions indicate low power of the corresponding frequency.
  • the power levels (of the ECG signal) are measured in units of (ms) 2 (milliseconds squared).
  • LF powers, HF powers and LF/HF ratios can be measured and averaged over a suitable time period (e.g. 24 hours) to provide parameters which can be compared with the with the autonomic data of a healthy population of the same age and sex, and percentiles can be calculated on this basis which indicate the deviation from the healthy norm.
  • a suitable time period e.g. 24 hours
  • percentiles can be calculated on this basis which indicate the deviation from the healthy norm.
  • Further information as to how HRV can be measured and interpreted can be found in "Guidelines Heart rate variability; Standards of measurement, physiological interpretation, and clinical use", European Heart Journal (1996) 17, 354-381 by the Task Force of The European Society of Cardiology and The North American Society of Pacing and Electrophysiology.
  • the frequencies are predominantly low, indicating that the sympathetic nervous system is most active during waking, as is necessary for high performance.
  • the patient is asleep and this is characterised by an initial, predominantly sympathetic activity followed by predominantly parasympathetic activity.
  • These phases correspond to the patient's sleep cycles of REM ("rapid eye movement") sleep (sleep phase 1 , and partly sleep phase 2) followed by non-REM sleep (sleep phases 2, 3 and 4).
  • the amplitude of the high frequencies (HF) is high, which is indicative of predominantly parasympathetic activity; and the amplitude of the low frequencies (LF) is low, indicating reduced sympathetic activity (strain) and hence enhanced rest and recovery.
  • HF high frequencies
  • LF low frequencies
  • the intensity of all frequencies - both sympathetic and parasympathetic - decreases with age and ill health.
  • the parasympathetic activity decreases faster than the sympathetic, increasing the LF/HF ratio with age and stress (although there are also some illnesses that may be reflected by too low a LF/HF ratio).
  • Heart rate variability (SDNN) also decreases with age, stress and ill health.
  • the lowering of HRV with age, illness and stress indicates an increased rigidity and a reduced adaptability of the ANS to external and internal stimuli.
  • HRV By stimulating each of the complementary facets of the ANS, through the application of light irradiation, the present inventors have found that an improvement in HRV is achievable. This may be perceived through an increase in SDNN, HRV coherence and/or amplitude (power) across the frequency spectrum - preferably all - as well as an improvement in LH/HF ratio in some cases.
  • preliminary studies have shown that the use of a device as described above can help reverse reduction in the patient's 24-hour mean of HRV (age, stress and illness induced) and can also enhance activity (i.e. increase intensity) in the low and/or high frequency spectrum and improve the LF/HF ratio.
  • HRV (SDNN) is usually measured via an electrocardiogram (ECG) which involves no health risk.
  • the activity of either of the two parts of the autonomic nervous systems may be stimulated or inhibited. For instance, in a patient with parasympathetic tendencies, only the sympathetic nervous system might be stimulated. The reverse is also true. More generally, the intensity of sympathetic and parasympathetic stimulation may not be equal, but should be in an age appropriate proportion (balance).
  • the present inventors have found that the different parts of the ANS can be stimulated or inhibited through the application of different wavelengths of light to the skin.
  • the longest wavelength of radiation is used to stimulate the sympathetic nervous system and inhibit the parasympathetic nervous system - for example, visible red light has metabolism-enhancing and accelerating effects on body processes.
  • the shortest wavelength is used to induce the opposite effect - for instance, visible blue or violet light stimulates the parasympathetic nervous system and reduces sympathetic activity, promoting rest and recuperation.
  • the other wavelength with which the device is equipped is an "intermediate" wavelength, such as visible green light, which has a balancing effect as will be described further below.
  • wavelengths are referred to here as “long(est)”, “intermediate” or “short(est)", it is the magnitude of the wavelength relative to the other wavelengths with which the device is equipped that is being described: the absolute magnitude of each is not critical. However, particularly preferred ranges for each radiation type are given below.
  • parts of the ANS activity can be enhanced (or inhibited) and ultimately the patient's HRV improved.
  • This improvement may be in the form of the patient's heart beat interval having an increased standard deviation (SDNN), and/or in the form of increased or reduced amplitude at least in frequency regions where the patient was previously deficient or too active, and/or an increase across all frequencies (sympathetic and parasympathetic). Whilst the effect of any individual application of the treatment will be temporary, if repeated over a period of time (e.g. days, weeks or months), a lasting improvement is achievable.
  • SDNN standard deviation
  • all of these aims are achieved by stimulating the self- regulating activity of the organism, without forcing the organism into fixed response patterns.
  • Some light irradiation sequences may result in different self-regulatory response of the ANS, dependent on the individual predisposition of the autonomic nervous system of the client at the time of the application.
  • the light irradiation sequence comprises at least one delay period between light packages, during which no radiation is emitted (it should be noted that it is not necessary to insert such a delay between every pair of consecutive light packages, although this is the preferred option).
  • the present inventors have found that such a delay period can amplify the biostimulative effect of the preceding light package(s). Without wishing to be bound to theory, it is speculated that this amplification effect may be a result of the body's counter- regulation to the initial stimulus, after its removal.
  • the delay period is preferably at least one minute in duration, and more preferably 5 minutes or more. Very short delays of less than a minute (which are more akin to a break between pulses of light) tend not to be of sufficient duration for the amplification effect to be of benefit.
  • the irradiation need not be carried out by someone with professional medical expertise: the device can preferably be fitted and operated by the patient themselves. Further, the treatment does not involve any significant health risk.
  • the device is arranged such that the emitted radiation irradiates a region of the patient's skin (not their eyes or eyelids).
  • the device could be configured in a housing which can be worn by the patient, e.g. strapped to the arm or leg, possibly during a night's sleep.
  • the light irradiation sequence will include at least three light packages, one of each of the three available wavelengths. Generally, only the selected one of the three wavelengths will be emitted during any one light package. However, provided the selected wavelength is dominant (i.e.
  • either or both the non-selected wavelengths could in fact be emitted to a lesser degree at the same time.
  • its effectiveness may not be significantly decreased if the second and/or third wavelengths are emitted concurrently at substantially lower doses.
  • the light irradiation sequence performed by the device can therefore be designed to include appropriate light package(s) which will deliver the required treatment to achieve the desired effect, and as described below, the device may include means for selecting an appropriate light irradiation sequence, adjusting an existing light irradiation sequence or downloading a new light irradiation sequence to be performed.
  • the device may be configured to perform a single pre-set light irradiation sequence, such as a sequence considered to be appropriate for the "average" patient.
  • the light irradiation sequence may comprise a delay period inserted only after selected light packages. For example, if the patient requires more parasympathetic stimulation than sympathetic, a delay period may be inserted after a light package of the shortest wavelength but not after other light packages.
  • the light irradiation sequence comprises first, second and third sequential light packages, each of a different one of the first, second and third wavelengths, and delay periods between the first and second, and second and third light packages.
  • the longest wavelength light package stimulates the sympathetic nervous system
  • the shortest wavelength light package stimulates the parasympathetic nervous system
  • the intermediate wavelength promotes a balancing effect (although it stimulates the parasympathetic nervous system slightly more than the sympathetic nervous system).
  • the biostimulative effect of each light package is reinforced by the delay period immediately thereafter, leading to particularly good results.
  • the light irradiation sequence could for example follow any of the following patterns:
  • sequences (i) and (ii) are most preferred. This is because, as already mentioned, in addition to HRV, the overall intensity of the frequencies and the LF/HF ratio, another indicator of health which can be determined from a patent's heart rate is the coherence of their heart rate variability. This is a measure of regularity (rhythm) in the heart rate variability.
  • Figures 2 (a) and (b) show the change in a patient's heart rate over time whilst experiencing (a) frustration, and (b) appreciation. Firstly, it will be seen that in trace (a), the patient's HRV (i.e. the change in amplitude between to adjacent peaks is generally low, whereas in trace (b) it is relatively high (around 20 to 30 bpm).
  • an intermediate wavelength such as green light not only assists in balancing the patient's ANS (and thus helps to achieve the desired, age-appropriate LF/HF ratio) but also increases the coherence of the patient's heart rate. This may be because the green light of intermediate wavelength has the capacity to stimulate sympathetic and parasympathetic activity, balancing both, but works slightly stronger towards a dominance of the parasympathetic activity. Parasympathetic activity, in general is rhythmogenic, enhancing coherence, whereas sympathetic activity is predominantly arrhythmogenic, reducing coherence. Thus applying an intermediate wavelength, such as green, combines the capacity to balance sympathetic and parasympathetic activity and to enhance coherence.
  • the light irradiation sequence comprises, in this order:
  • step (c) a light package of the other of the longest or the shortest wavelength, whichever is not emitted in step (a);
  • Irradiation sequences such as this have been found to be particularly effective since the delay periods amplify the effects of each preceding simulative light package, and the intermediate wavelength light package then improves the coherence of the patient's heart rate without undoing the amplified effects of the preceding steps. It is particularly advantageous if the intermediate light package is the final light package of the irradiation sequence, so that the high coherence level achieved is not subsequently disrupted.
  • step (a) stimulates the patient's ANS through promotion of either their sympathetic nervous system (longest wavelength) or their parasympathetic nervous system (shortest wavelength).
  • the result typically involves an increase or decrease in the intensities of at least one or more of the frequency components of their power spectrum (LF or HF).
  • Step (b) reinforces the effect of step (a) by amplifying the achieved effects. This is found to be particularly the case where the delay period follows a light package of the shorter wavelength.
  • Step (c) then stimulates the opposite facet of the ANS, and the subsequent delay period once again reinforces the effect. Again, certain frequencies of the power spectrum will be amplified or suppressed.
  • steps (a) to (d) have been found to result in an increase in the patient's HRV (SDNN) and/or an overall increase in high and/or low frequency activity.
  • these improvements are sometimes accompanied by a decrease in coherence.
  • Step (e) addresses this and/or provides additional benefits by increasing the coherence of the patient's heart rate without losing the biostimulative effect (e.g. increase in HRV (SDNN) and/or activity of the ANS, LF and/or HF amplitudes) that has been achieved by steps (a) to (d).
  • steps (a), to (e) follow on directly from one another with no intervening steps. It should be noted that the degree of stimulation of the two parts of the ANS need not be equal.
  • a light irradiation sequence in which the light package in step (a) is of the shortest wavelength and the light package in step (c) is of the longest wavelength is particularly suited to application during the patient's waking hours, e.g. in the morning.
  • a light irradiation sequence in which the light package in step (a) is of the longest wavelength and the light package in step (c) is of the shortest wavelength is particularly suited to application when the patient is preparing to sleep or is asleep, e.g. during the afternoon or night time.
  • the light irradiation may come to an end once the three light packages of the sequence have been delivered (followed by a de facto delay period which will reinforce the effects of the last light package).
  • desirable results can be achieved by continuing to deliver doses of light.
  • the third light package is followed by a further delay period and then a second light irradiation sequence including at least one light package of the first wavelength, at least one light package of the second wavelength and at least one light package of the third wavelength, and wherein the second light irradiation sequence comprises at least one delay period between light packages, during which no radiation is emitted.
  • the second light irradiation sequence could also comprise the steps (a) to (e) discussed above.
  • the second light irradiation sequence may be a repetition of the preceding light irradiation sequence.
  • a pattern could be repeated with a longer periodicity - for example, two or more different light irradiation sequences may be alternated.
  • the second light irradiation sequence is followed by one or more further light irradiation sequences, a delay period occurring between each light irradiation sequence. For example, four or six or more sequences may be performed in series.
  • the pattern of light packages in the series of light irradiation sequences has a regular repeat. However, this is not essential and in some cases enhanced flexibility of the ANS can be achieved by applying a pseudorandom series of sequences.
  • the light package of the intermediate wavelength is preferably the final light package of the irradiation sequence. That is, the device does not emit any further radiation until the next application of the treatment is instigated (e.g. by user input).
  • a combined long and short wavelength light package of this sort can shorten the overall duration of the light irradiation sequence, since both parts of the ANS are stimulated at the same time.
  • a combined long and short wavelength light package may be supplemented with a single-wavelength light package, e.g. where the patient has a tendency towards sympathetic or parasympathetic activity.
  • a delay period may or may not be inserted between the adjacent light packages.
  • the delay period(s) should be sufficiently long.
  • the or each delay period in the light irradiation sequence has a duration of 1 minute or greater, preferably between 1 and 120 minutes, more preferably between 2 and 90 minutes, still preferably between 3 and 75 minutes, most preferably between 4 and 60 minutes.
  • delay periods of around 5 minutes or greater are preferred.
  • the precise duration may be selected dependent on the duration of the preceding and/or subsequent light packages.
  • the or each delay period could have a duration similar to the duration of the immediately preceding light package, e.g. to within +/- 50% of the preceding light package duration.
  • each delay period in the or each light irradiation sequence has approximately the same duration.
  • each light package has a duration of 1 minute or greater, preferably between 1 and 120 minutes, more preferably between 5 and 90 minutes, still preferably between 15 and 75 minutes, most preferably between 20 and 60 minutes. The precise duration will depend on the radiation dosage that is to be delivered and on the output parameters of the radiation emitter assembly.
  • each light package in each light irradiation sequence has approximately the same duration, but this is not essential.
  • the total light energy dosage of any one of the wavelengths emitted in each light package is between 5 and 200 J, more preferably between 10 and 100 J, still preferably between 10 and 80 J, most preferably between 15 and 60 J.
  • the total light energy dosage emitted in each light package of the light irradiation sequence is usually preferably approximately the same.
  • the total light energy dosage of the longest wavelength or the shortest wavelength emitted in the light irradiation sequence may preferably be equal or less than that of the intermediate wavelength.
  • the total light energy dosage of all wavelengths emitted in the light irradiation sequence is preferably between 10 and 500 J, preferably between 20 and 200 J, more preferably between 30 and 150 J, still preferably between 40 and 120 J. These levels of energy have been found to produce the necessary level of stimulus whilst avoiding damage to the skin or other negative side effects.
  • All three wavelengths of radiation are preferably visible light.
  • each of the at least two wavelengths advantageously lie within the visible or near-visible spectrum, preferably within the range of about 300 to 930 nm.
  • the radiation should preferably not have any harmful effects (such as the known carcinogenic effects of X-rays, UVB and UVC for example).
  • the longest and shortest of the first, second and third wavelengths are at opposite ends of the visible spectrum, and the other, intermediate wavelength is between the longest and shortest wavelengths, preferably at approximately their midpoint.
  • the longest wavelength is more than 590 nm
  • the shorter wavelength is less than 490 nm.
  • the longer wavelength is advantageously at least 100 nm longer than the shorter wavelength, preferably at least 150 nm longer, more preferably at least 200 nm longer, most preferably around 240 nm longer.
  • the shorter and/or longer wavelengths must be shorter or longer (respectively) than the intermediate wavelength. For instance, if an intermediate wavelength of 532 nm is supplied, the longer wavelength could take any value greater than 532 nm, and the shorter wavelength any value less than 532 nm.
  • the longest of the first, second and third wavelengths is between 590 and 930 nm, preferably between 640 and 720 nm, more preferably approximately 660 nm +/- 10 nm. Radiation of this type is generally referred to as "red” in the following description, and has been found by the present inventors to achieve stimulation of the sympathetic nervous system.
  • the intermediate wavelength of the first, second and third wavelengths is advantageously between 490 and 590 nm, preferably between 500 and 550 nm, more preferably approximately 532 nm +/- 10 nm. Radiation of this sort is generally referred to as "green” below, and has been found by the present inventors to achieve the above described balancing effect on the ANS.
  • the shortest of the first, second and third wavelengths is between 350 and 490 nm, preferably between 400 and 425 nm, more preferably approximately 420 nm +/- 10 nm. Radiation of this type is generally referred to as “blue” or “violet” in the following description, and has been found by the present inventors to stimulate the parasympathetic nervous system.
  • each dose of radiation is delivered continuously - that is, the radiation emitter assembly constantly emits light at the required wavelength(s) for the whole duration of each light emission step.
  • pulse modulated radiation is also envisaged, and may have benefits in certain cases.
  • at least one of the one or more light packages of the light irradiation sequence may be output by emitting pulsed radiation.
  • the pulsed radiation has a pulse frequency of between 0.05 and 0.2 Hz, preferably approximately 0.1 Hz. It is believed this is due to resonance between the applied radiation pulses and blood pressure oscillations, known as Mayer waves, which are known to have a frequency of around 0.1 Hz.
  • the pulsed radiation has a duty cycle of between 35 and 65%, preferably approximately 50%. It should be noted that the breaks in such pulsed implementations will be shorter than the delay periods discussed above, i.e. less than 1 minute (generally only a few seconds at most) and hence do not cause amplification of the effects through the same mechanism. In general a series of pulses of one colour punctuated by such short breaks in this way is taken to constitute a single "light package”.
  • sequence (i) mentioned above has a stimulating, awakening effect and may be provided for application in the morning (or during the night if the patient is a night shift worker, for instance).
  • sequence (ii) which increases parasympathetic activity, has calming, sleep inducing and recuperating effects and may be provided for use in the evening, before going to sleep.
  • the device further comprises a scheduler adapted to control the time at which the light irradiation sequence is output.
  • the scheduler could be adapted to initiate outputting of the light irradiation sequence in response to a start signal from the user, preferably after a predetermined or user-selected interval. Such an interval is of particular use where the light irradiation sequence is to be delivered while the patient is asleep, as discussed further below.
  • the scheduler could be configured to initiate the light irradiation sequence at a particular time (e.g. 8 a.m. GMT).
  • the device could be worn near-continuously by the patient with light irradiation sequences being performed at predetermined times under the control of the scheduler.
  • the scheduler may be implemented by the controller (e.g. in the form of programming or a hard-wired circuit) but typically may make use of inputs from other components such as a user interface and/or a sensor for monitoring the physiological state of the patient (described in more detail below).
  • the scheduler may perform alignment based on a clock or counter.
  • Performing the light irradiation sequence during sleep also has a number of other benefits, including the possibility of aligning the delivery of the light packages with the patient's sleep cycles which can increase the body's receptivity to the stimulation and, in some implementations, also enhance the patient's sleep.
  • Sleep is a vital part of the body's repair and regeneration cycle and it is known that a poor sleeping pattern can lead to poor health as well as causing day-to-day dysfunction.
  • improving a patient's sleeping regime can have significant benefits on the patient's energy levels and other functions during the day and night.
  • Non-REM sleep stage 1 is also relatively light, whereas non-REM sleep stages 3 and 4 promote restoration of the body.
  • Sleep stage 2 has an intermediate function.
  • a person should experience 4 to 5 sleep cycles, each having a non-REM phase followed by a REM phase, during a night's sleep.
  • the non-REM phase has a typical duration of around 80 minutes (made up of approximately 10 minutes stage 1 , 50 minutes stage 2 and 20 minutes stages 3/4, followed by a REM phase of around 10 minutes.
  • the different sleep phases are characterised by changes in activity of the ANS: during REM sleep and stage 1 non-REM sleep the sympathetic nervous system is more engaged, whereas during non-REM sleep stages 3 and 4 the parasympathetic nervous system dominates. In sleep stage 2 both the sympathetic and parasympathetic nervous system are engaged in a more balanced fashion. It has been observed that, during a person's sleep cycle, a change in autonomic nervous system activity (e.g. from sympathetic to parasympathetic) will occur first and be followed by a corresponding change from one sleep phase to another, as can be seen in the changed brain wave patterns through an EEG (e.g.
  • the scheduler is adapted to align performance of the light irradiation sequence with a sleep cycle associated with the patient such that at least one of the light packages is output in alignment with a selected phase of the sleep cycle. This may or may not be with the aim of entraining the patient's sleep pattern.
  • "entrainment" of a circadian system is the alignment of its own period and phase to the period and phase of an external rhythm.
  • the device can promote selected sleep phases and/or aid the transition from one to another.
  • the longer wavelength of radiation may be used to encourage non-REM stage 1 and REM sleep for example.
  • the shorter wavelength may be used to induce the opposite effect, for instance visible blue or violet light can be used to promote non-REM stage 2, 3 and 4 sleep.
  • the intermediate wavelength such as green, has been found to promote non-REM stage 2 sleep even more effectively than shorter wavelengths and more effectively than a simultaneous application of the shorter and longer wavelength.
  • the patient's sleeping habits can be modified and, ultimately, the patient's sleep cycle entrained over time to improve their sleeping pattern. This is in addition to the device's underlying aims of improving the patient's HRV (SDNN and/or coherence) and/or regulating the balance of the autonomic nervous system (LF, HF and LF/HV ratio).
  • sleep entraining may be achieved by delivering light of the appropriate wavelength during one or more selected sleep phases to enhance only those sleep phases (e.g.
  • the device can be used to assist the transition from one sleep phase to another, by delivering consecutive light packages of the two alternate wavelengths at an appropriate time in the patient's sleep cycle to encourage a switch between sleep phases.
  • the delivery of at least one of the light packages is arranged to coincide with an appropriate sleep phase of the patient.
  • sleep entrainment is an additional aim, it is preferred that longer wavelength light packages of the light irradiation sequence should generally be outputted during REM or non-REM stage 1 portions of the sleep cycle, whereas shorter wavelength light packages should generally be outputted during non-REM stage 2, 3 and 4 sleep phases.
  • an opposite schedule achieves results of increased HRV.
  • applying shorter wavelength light during REM or non-REM stage 1 sleep to stimulate the parasympathetic nervous system may have an enhanced effect due to the increased strain placed on the ANS (comparable to the results of a combined short and long wavelength light package), and may also give rise to increased counter-regulation of the organism during a subsequent delay period (if provided), when no light is applied.
  • this sleep cycle with which the light irradiation sequence is aligned need not be based on that of the particular patient in question (although this is an option), but more typically will be a "generic" sleep cycle known to apply generally to patients of the relevant type, e.g. humans. Further, it may be sufficient only to align one, or a subset of, the light packages with the sleep cycle, the preceding or subsequent light packages being output according to their desired durations and any delay periods inserted in the sequence. For instance, in patients who have disturbed sleep during their first and second sleep cycles during a night, if the light irradiation is to be used to support each sleep phase, it may be scheduled to coincide with the first or second sleep cycle as appropriate.
  • the sleep cycle it may be preferred to postpone delivery of the irradiation until later in the night (e.g. the third sleep cycle), when the sleep is less disrupted, to avoid causing any additional disturbance to the already-disturbed period.
  • the start of the light irradiation sequence need be scheduled to align with any sleep phase (here, the non-REM phase of the third sleep cycle), with the subsequent timings being based primarily on desired radiation doses rather than the sleep cycle.
  • the alignment may be achieved by outputting at least one of the light packages at predetermined times relative to a start signal from the user or to a trigger signal from a sensor indicating that the patient has fallen asleep.
  • at least one of the light packages of the light irradiation sequence is output according to pre-determined timings based on a theoretical sleep cycle or on the known sleep cycle of the patient.
  • a "theoretical sleep cycle” it is meant a generic (e.g. average or ideal) sleep cycle known for the type of patient in question - for example, the typical sleep cycle for humans is described above, but the corresponding typical timings for different species of animal may be different. The typical timing for humans may also vary by age.
  • the predetermined timings can be tailored to the particular sleep cycle of the patient in question. This can be achieved by monitoring the patient's sleeping pattern to identify the duration of each sleep phase, and designing the light irradiation sequence accordingly.
  • the predetermined timings can be considered parameters of the light irradiation sequence.
  • the scheduler may align the light packages with the patient's sleep phases based on feedback from the patient.
  • the device may further comprise a physiological state sensor adapted to detect a parameter of the patient related to the patient's physiological state and to output a corresponding physiological state signal.
  • the physiological state signal can be used to provide read-time feedback and, in a preferred implementation, the one or more light packages of the light irradiation sequence are output in response to the physiological state signal. That is, the timing of the light packages can be aligned with the patient's natural sleep phases, by regulating the delivery as a result of their sleep state.
  • the physiological state signal may be used to determine when the patient transitions from one sleep state to another, at which point a light package currently being output may be terminated and/or a new light package begun.
  • the light irradiation sequence data need specify only the number and/or order and/or wavelength of the different light packages to be output, without any timing information.
  • Feedback from the sensor could also be used in combination with a clock-based scheduling process, e.g. to adjust pre-determined timings of the light irradiation sequence to bring them closer to the patient's actual sleep cycle parameters.
  • Such adjustment may be dynamic (i.e. modifying the light irradiation sequence currently in progress) or the feedback may be retained for adjustment of a future light irradiation sequence yet to be performed.
  • the physiological state sensor could be used at any time of day and is not confined to determining a patient's sleep state.
  • the sensor signal could be used to monitor for the patient's alertness levels dropping below a pre-set threshold, which could trigger the outputting of a light irradiation sequence designed to stimulate the patient and improve alertness.
  • the scheduler may initiate performance of the light irradiation sequence based either on input from a user (who may or may not be the patient), or on feedback from the patient, or using both in combination.
  • the scheduler is adapted to initiate outputting of the light irradiation sequence in response to a start signal from the user after a predetermined interval.
  • the start signal may be issued upon the user switching the device on and, after a delay interval of e.g. 10 minutes (to allow time for the patient to fall asleep), the scheduler may initiate the light irradiation.
  • the delay may be around 90 minutes, or a multiple thereof, to postpone delivery of the light irradiation sequence until the start of the second or subsequent sleep cycle.
  • the delay may be preset or user-selectable.
  • the scheduler is adapted to initiate outputting of the light irradiation sequence in response to a trigger in the sleep state signal output by the sleep state sensor.
  • the timing of the light packages can be more accurately aligned with the patient's natural sleep phases.
  • the light irradiation sequence may be initiated upon detecting that the patient has fallen asleep.
  • the trigger could be some other transition in the patient's sleep cycle, e.g. the start of the first REM sleep phase.
  • the sleep state signal could be used to assess the patient's depth of sleep at any one time, and accordingly trigger the start of the light irradiation sequence when the patient's sleep state is deemed optimal for the therapy, independent of any sleep disturbance. This may be at the time of most superficial or deepest sleep (or somewhere in between), depending on the patient.
  • the scheduling of the light packages in the light irradiation sequence can be clock-based or feedback-based (or both).
  • the physiological state sensor could be implemented in many different forms, but in preferred examples, the physiological state sensor comprises a motion sensor, a plurality of electrodes for detecting electrical activity of the heart (ECG) or brain (EEG), or a pulse monitoring system.
  • ECG electrical activity of the heart
  • EEG brain
  • pulse monitoring system a pulse monitoring system
  • a motion sensor could comprise one or more accelerometers adapted to detect motion of the patient along one or more axes. This is particularly appropriate where the physiological state sensor is to be used to ascertain the patient's sleep state. Since a person's movements will change upon falling asleep, and depend upon their sleep state, the detected motion can be compared with stored templates, or pattern recognition could be performed on the output signal, to determine the point at which the patient falls asleep and/or their current sleep state (e.g. which sleep phase they are experiencing). Alternatively the patient's current ANS activity levels can be obtained by using electrodes to monitor the heart's activity in the same way that forms the basis of an electrocardiogram (ECG). This will vary depending on the patient's sleep phase but also throughout the day.
  • ECG electrocardiogram
  • the device controller can be programmed to analyse the electrical signals in much the same way as a conventional ECG apparatus, or the device could be connected to an external ECG apparatus.
  • the patient's pulse could be monitored, e.g. using a photo-optic element connected to a pulse monitoring system (which may form part of the controller or could be external to the device), which may be able to analyse the patient's physiological state via power spectrum analysis of their heart rate variability (HRV).
  • HRV heart rate variability
  • a breath monitoring system could be used instead.
  • Electroencephalography EEG
  • EEG Electroencephalography
  • the controller comprises a memory for storing the light irradiation sequence or a plurality of light irradiation sequences.
  • the light irradiation sequence to be performed can be changed either by writing a new sequence to the memory or, in particularly advantageous embodiments, by providing a mode selector for selecting between a plurality of light irradiation sequences stored in the memory.
  • the user (which may be the patient or another person such as a sleep specialist, for instance) can select the most appropriate sequence for their needs from a set pre-programmed into the device.
  • the available light sequences could include any of those already mentioned above. Further, variants of the same sequences could be provided which are adjusted for patients with underlying sympathetic or parasympathetic tendencies. In the former, the relative dosage of shorter wavelength radiation may be increased (e.g. by increasing the duration of the "blue" light package(s), or conversely decreasing that of other wavelengths), and in the latter, the relative dosage of longer wavelength radiation may be increased. The dosage of intermediate wavelengths, if used, may also be adjusted to account for the patient's intrinsic coherence levels.
  • the required light irradiation sequence(s) may also need to be changed as the patient progresses through treatment.
  • a patient with a strong tendency towards sympathetic nervous activity may begin treatment with a light irradiation sequence biased towards shorter wavelengths as mentioned above.
  • the patient's ANS activity should become more balanced and it may be appropriate to change to light irradiation sequence in which the dosages of each wavelength are more similar.
  • the memory has stored therein a plurality of light irradiation sequences and the controller is adapted to select between the plurality of light irradiation sequences in accordance with a treatment programme also stored in memory.
  • the treatment programme may be standard (i.e. appropriate for a generic "average" patient) or could be prescribed by a specialist for the patient in question.
  • the treatment programme could specify which of the plurality of light irradiation sequences should be performed on which date(s), or that the light irradiation sequence selected should be switched from one to another after a certain number of treatment cycles have been completed.
  • the treatment programme could therefore be clock (or calendar) based, or counter-based.
  • the treatment programme could be feedback-based, selecting a different one of the light irradiation sequences in response to the physiological state signal.
  • all of the required light irradiation sequences could be pre-programmed into the device for manual or automatic selection, in digital or hard-wired (analogue) form.
  • the device further comprises a communications port for receiving one or more light irradiation sequences and/or treatment programmes from an external source for storage in the memory.
  • a communications port for receiving one or more light irradiation sequences and/or treatment programmes from an external source for storage in the memory.
  • This could be a wired and/or wireless communication means, such as a USB connection, a wireless internet connection (e.g. WiFi), an infrared transponder or a Bluetooth® link.
  • the device could be connected directly and/or indirectly (e.g.
  • an intranet, cellular network, PSTN or any other network to an external CPU, such as a computer, having appropriate software to select or configure one or more light irradiation sequences and transfer them to the memory of the device.
  • the external device could be a memory store such as a ROM, e.g. a USB stick, on which one or more light irradiation sequences are stored, which are transferred to the device memory upon connection.
  • a treatment programme could be stored on the external device which communicates wirelessly with the device itself, updating the light irradiation sequence at appropriate points, in the same way as described above.
  • the device could be configurable to operate in a monitoring mode, in which the physiological state signal is recorded in memory, without performing any light irradiation sequence.
  • the stored signal can then be analysed, e.g. by downloading it from the device to a computer provided with suitable software or forwarding to a specialist for review using any of the communication means described above, and an appropriate light irradiation sequence devised for the patient based on the outcome.
  • the recorded sleep state signal could be used by the device controller itself, for example to adjust future light irradiation sequences or as an input to a treatment programme as mentioned above.
  • the radiation emitter assembly can be of any form able to emit each of the at least three required wavelengths of light independently of one another and at the desired energy levels.
  • the radiation emitter assembly could take the form of a light emitting device which can vary the wavelength of its emitted radiation, at least between the first, second and third wavelengths.
  • the radiation emitter assembly comprises at least first, second and third narrow band light emitters adapted to emit light at the first, second and third wavelengths, respectively.
  • the use of narrow band emitters ensures that, during each emission step, radiation of the specific desired wavelength can be emitted straightforwardly by switching on the appropriate emitter whilst keeping the others switched off.
  • the other, non-selected emitters are entirely inactive during a light package, provided the selected wavelength dominates the overall emission.
  • a single emitter of each type could be deployed.
  • the radiation emitter assembly comprises a plurality of first narrow band light emitters and/or a plurality of second narrow band light emitters and/or a plurality of third narrow band light emitters preferably arranged in an array. This provides greater design freedom and can be used to tailor the dosage of each light package.
  • a display unit formed of multiple emitters, could be used as the radiation emitter assembly.
  • the first, second and third narrow band light emitters comprise LEDs, organic LEDs ("OLEDs"), lasers or any other light source.
  • OLEDs organic LEDs
  • lasers the use of lasers is less preferred since these introduce health and safety risks and hence in particularly preferred implementations the radiation emitter assembly does not include a laser.
  • the radiation emitter assembly is arranged to apply the radiation directly to the patient's skin, the radiation emitter assembly preferably being configured to contact the patient's skin in use. This could be achieved either by positioning the light generating components (e.g. LEDs) to contact the skin directly or via an optically transparent component such as a window or fibre optic cables, if it is preferred to locate the light generating parts away from the patient.
  • the light generating components e.g. LEDs
  • the device further comprises an attachment member for attaching the device to a patient, the attachment member preferably comprising at least one strap.
  • the attachment member is configured to urge the radiation emitter assembly against the patient's skin in use. This not only ensures that the radiation emitter is kept at a known distance from the patient's skin (which may be zero but where there is a window is typically of the order of 1 mm or 0.5 mm or less, which corresponds to the thickness of the window), but also the possibility of stray radiation striking a person's eyes is minimized. It should be noted that the radiation is to be applied to a region of the patient's skin, and not their eyes (or eyelids) since retinal absorption of light leads to different effects from those described above.
  • the device is attached to the patient's limb or torso and hence the preferred urging of the radiation assembly against the skin does not give rise to discomfort.
  • the device could be remote controlled and/or connected to a computer through which operating commands can be entered.
  • the device further comprises a user interface having at least one input member for receiving commands from a user, the at least one input member preferably comprising an on/off switch, actuation of which issues a start signal to the controller.
  • the on/off switch could comprise a push button or a slidable switch.
  • the user interface may also comprise other input members such as a mode selection switch, actuation of which issue a mode selection signal to the mode selector to enable selection of one of the plurality of light irradiation sequences.
  • the interface could also include a display, such as a LCD or backlit LCD, for communicating information such as which light irradiation sequence is currently selected.
  • a display such as a LCD or backlit LCD
  • the at least one input member is arranged so as to be located between the device and the patient's skin when in use. This provides the benefit that the switches and/or buttons cannot be accessed when the device is fitted to the patient, preventing accidental actuation while the user is asleep.
  • the device can only be activated once fitted to a patient such that radiation will only be emitted once the radiation emitter assembly is covered by the patient's skin. This avoids potential damage to the user's eyes should the radiation emitter assembly accidentally be viewed whilst on.
  • the device therefore preferably further comprises a contact sensor configured to detect whether the device is fitted against a patient's skin and, if not, to output a disable signal causing the controller to switch off the radiation emitting assembly.
  • the contact sensor is formed by the on/off switch of the user interface configured such that depressing of the switch against the patient's skin actuates the switch to issue the start signal, and releasing of the switch upon removal of the device from the patient causes the disable signal to be issued.
  • the device could be powered via cables, e.g. from a mains supply, possibly via a transformer.
  • the power source should be an onboard power source, preferably a battery.
  • the power source is a rechargeable battery, preferably a lithium polymer rechargeable battery. The battery should have sufficient capacity to maintain the required power output from the radiation emitter assembly for each light package, and should preferably be able to be recharged in less than 8 hours.
  • the controller is adapted to disable the radiation emitter assembly during charging of the battery, for example by arranging the recharging socket to be inaccessible when the device is worn and/or through an interlock.
  • the radiation emitter assembly, power source and controller are mounted in a (portable) housing configured for attachment to a patient, the radiation emitter assembly being arranged to emit radiation through a surface of the housing abutting the patient's skin in use.
  • the device further comprises an attachment member for attaching the housing to the patient, the attachment member preferably comprising at least one strap.
  • the device could be designed to be strapped to the patient's arm or leg.
  • the device may be adapted to be worn as a watch around the patient's wrist and may even be provided with a digital or analogue clock face on the outer surface so that it can additionally function as a watch and/or alarm clock.
  • the housing (including any window provided to cover the radiation emitter assembly) and/or attachment member are formed of hypoallergenic materials.
  • the device can be used in the treatment of a patient for either therapeutic or non- therapeutic purposes through the above-described entrainment of the ANS.
  • Examples of the former include use of the device in the treatment of conditions such as but not limited to chronic heart disease, insomnia, MS, ME and fatigue.
  • Examples of non-therapeutic uses include enhancing mental and physical performance, rejuvenation, and anti-aging, as well as stress relief and improving sleep quality.
  • a program for controlling a radiation emitter assembly for the treatment of a patient by light irradiation comprising instructions for: actuating the radiation emitter assembly to output a light irradiation sequence of three or more sequential light packages, wherein the or each light package is output by emitting light at one of the first, second and third wavelengths for a period of time, the light irradiation sequence including at least one light package of the first wavelength, at least one light package of the second wavelength and at least one light package of the third wavelength, and wherein the light irradiation sequence comprises at least one delay period between light packages, during which no radiation is emitted.
  • the program can be adapted to control the radiation emitter assembly to deliver any of the light irradiation sequences described above, and can be modified to include any of the control / scheduling features already described.
  • the invention also provides a computer program product on which the program is stored.
  • a method of treating a patient by light irradiation comprising: using a radiation emitter assembly adapted to emit light at each of at least first, second and third wavelengths, sequentially, to irradiate a region of the patient's skin with a light irradiation sequence of three or more sequential light packages, wherein the or each light package is output by emitting light at one of the first, second and third wavelengths for a period of time, the light irradiation sequence including at least one light package of the first wavelength, at least one light package of the second wavelength and at least one light package of the third wavelength, and wherein the light irradiation sequence comprises at least one delay period between light packages, during which no radiation is emitted.
  • the method can involve any of the steps described above as performed by the aforementioned device.
  • the method is preferably used in the entrainment of a patient's ANS, and as mentioned above may be employed to alleviate conditions such as but not limited to chronic heart disease, insomnia, MS, ME and fatigue, as well as to promote enhanced mental and physical performance, rejuvenation, and anti-aging, as well as stress relief and improved sleep quality.
  • a further aspect of the invention provides light irradiation comprising light at each of at least first, second and third wavelengths, for use in therapy, wherein the light irradiation is dosed by applying a light irradiation sequence of three or more sequential light packages, wherein the or each light package is output by emitting light at one of the first, second and third wavelength for a period of time, the light irradiation sequence including at least one light package of the first wavelength, at least one light package of the second wavelength and at least one light package of the third wavelength, and wherein the light irradiation sequence comprises at least one delay period between light packages, during which no radiation is emitted.
  • the light irradiation is for use in the therapy of treating the autonomic nervous system (ANS) or the therapy of fatigue, myalgic encephalomyelitis (ME), post-viral fatigue syndrome (PVFS), chronic fatigue immune dysfunction syndrome (CFIDS), stress, ageing, jet lag (desynchronosis), cardiac and cardiovascular diseases such as cardiac arrhythymia, cancer, hepatitis, AIDS, autoimmune diseases such as rheumatoid arthritis and lupus, asthma or insomnia.
  • ANS autonomic nervous system
  • ME myalgic encephalomyelitis
  • PVFS post-viral fatigue syndrome
  • CIDS chronic fatigue immune dysfunction syndrome
  • stress ageing
  • jet lag desynchronosis
  • cardiac and cardiovascular diseases such as cardiac arrhythymia, cancer, hepatitis, AIDS, autoimmune diseases such as rheumatoid arthritis and lupus, asthma or insomnia.
  • the light irradiation is applied to the skin (i.e. not the eyes, eyelids or retina).
  • the light irradiation sequence can take any of the forms discussed above.
  • Figure 1 is an exemplary HRV power spectrum of a typical patient
  • Figures 2(a) and (b) illustrate the change in heart rate over time for a typical patient experiencing (a) frustration and (b) appreciation;
  • Figure 3 shows schematically a first embodiment of a light irradiation treatment device
  • Figure 4 is a flow diagram showing steps in a first embodiment of a light irradiation method and of a program which can be used to control the device of Figure 3;
  • Figure 5(a) shows a second embodiment of a light irradiation treatment device and Figure 5(b) schematically shows the device of Figure 5(a) worn by a patient;
  • Figure 6 shows a cross section through the device of Figure 5(a) in situ on a patient
  • Figure 7 is a flow diagram showing steps in a second embodiment of a light irradiation method and of a program which can be used to control a light irradiation treatment device;
  • FIGS 8(a) and (b) show further steps which may be performed
  • Figure 9 is a plot illustrating light emission at each of three wavelengths over time in the Figure 7 embodiment.
  • Figure 10 is a flow diagram showing steps in a further embodiment of a light irradiation method and of a program which can be used to control a light irradiation treatment device;
  • Figure 11 is a plot illustrating light emission at each of three wavelengths over time in the Figure 10 embodiment
  • Figures 12 (a) to (g) are plots illustrating exemplary power spectrums showing the influence of various different light packages on a patient;
  • Figure 13 is a flow diagram showing steps in a further embodiment of a light irradiation method and of a program which can be used to control a light irradiation device;
  • Figure 14 is a plot illustrating a sleep state signal and light emission at each of three wavelengths triggered by the sleep state signal, over time in the embodiment of Figure 13;
  • Figures 15a and 15b illustrate a further embodiment of a light irradiation treatment device, in front and back view respectively;
  • Figure 16 shows the light irradiation treatment device of Figure 15 connected to an external device
  • Figure 17 is a block diagram illustrating interactions between selected components of a light irradiation treatment device in another embodiment
  • Figure 18 is a flow diagram showing steps in a further embodiment of a light irradiation method and of a program which can be used to control a light irradiation treatment device;
  • Figure 19 is a plot illustrating light emission at each of two wavelengths over time in the Figure 18 embodiment
  • Figure 20 is a plot illustrating light emission at each of two wavelengths over time in another embodiment
  • Figure 21 is a flow diagram showing steps in a further embodiment of a light irradiation method and of a program which can be used to control a light irradiation device;
  • Figure 22 is a plot illustrating a sleep state signal and light emission at each of three wavelengths triggered by the sleep state signal, over time, in the embodiment of Figure 21 ;
  • Figure 23 is a flow diagram showing steps in a further embodiment of a light irradiation method and of a program which can be used to control a light irradiation device;
  • Figure 24 is a plot illustrating light emission at each of three wavelengths in another embodiment.
  • the ensuing description will focus on the application of light irradiation treatment to human patients. However, it will be appreciated that the same principles can be applied to the treatment of animals. It should also be noted that the term "patient”, wherever used in this disclosure, should not be construed as implying that the person or animal is suffering from an illness or other disorder. Rather, the disclosed techniques can be beneficially applied to anyone.
  • HRV heart rate variability
  • HF high
  • LF low frequencies
  • HRV heart rate variability
  • HF high
  • LF low frequencies
  • HRV is an important diagnostic (autonomic nervous system activity) and prognostic (morbidity, mortality and risk of accidents) tool and can also be an indicator for the adaptability, flexibility, youthfulness and health potential of the organism. Entraining and enhancing the patient's ANS in this way may therefore bring about significant benefits including:
  • FIG. 3 schematically shows a first embodiment of a device 1 which can be used for light irradiation treatment of a patient P.
  • the device 1 comprises a radiation emitter assembly 2 which is able to emit light at at least three different wavelengths, individually (e.g. one after the other, rather than simultaneously - although in some cases, more than one of the wavelengths could be activated concurrently, as will be detailed below).
  • the assembly 2 could be formed of a light emitting device able to change the colour of light emitted, e.g. upon application of different driving currents and/or voltages, or could comprise three or more light emitting devices each of which is able to emit light at one of the desired wavelengths, such as LEDs.
  • the desired wavelengths could also be obtained through the use of appropriate filters forming part of the radiation emitting assembly. For instance, one or more white light emitters could be used in conjunction with appropriate coloured filters.
  • the assembly 2 could also take the form of a display screen.
  • a power source 3 is provided for supplying power to the radiation emitter assembly. This could take any desirable form, including mains power, but is preferably an onboard supply for increased safety and portability, such as a rechargeable battery.
  • the activation of the radiation emitter assembly 2 is managed by a controller 4, which may take the form of a hard-wired circuit or a programmed microcontroller for example.
  • the radiation emitter assembly is controlled to deliver a light irradiation sequence including three or more sequential packages of light to the patient P.
  • Each light package involves the emission of one of the three available wavelengths.
  • a waveband including the selected wavelength will typically be emitted (unless the assembly comprises three truly monochromatic sources). It is preferred that the three wavebands do not significantly overlap one another. However, a small amount of overlap where the intensity of emission is low is permissible.
  • either of the two non-selected wavelengths could be emitted to a lesser degree during any one light package, provided the selected wavelength remains dominant - i.e. the effects of the selected wavelength on the patient outweigh the influence of the two non-selected wavelengths.
  • the light irradiation sequence to be performed can take a number of different forms, depending on the needs of the patient and/or the desired effect. In some cases, it is preferred that the light irradiation sequence is applied while the patient is asleep, in order to avoid disruption during the day. Application during sleep also has a number of other benefits as will be discussed below. However, in other examples, the light irradiation sequence is to be applied during the day. In general, therefore, it is desirable to be able to control the time at which a light irradiation sequence is delivered, in terms of the time of day/night and/or relative to the patient's physiological condition (which will also vary over time).
  • the "scheduling" of the light irradiation sequence can be achieved in a number of ways. In most cases, including the present embodiment, this is achieved by including pre- determined timings in the light irradiation sequence and initiating the sequence in response to the switching-on of the device. In some examples, described below, a sensor may be used to obtain feedback from the patient and this can also be used to trigger (all or part of) the irradiation sequence and/or to control the duration of one or more of the light irradiation steps.
  • Figure 4 shows steps performed by the controller 4 in the first embodiment.
  • the device 1 is fitted to the patient.
  • the radiation emitter assembly should be arranged to directly irradiate a region of the patient's skin, conveniently on the arm or leg (not the eye or eyelid).
  • the device is switched on (step S101) by the patient or remotely.
  • the controller activates the radiation emitter assembly to emit a light irradiation sequence (step S1 10) which in this example is formed of three light irradiation steps.
  • light at a first wavelength is emitted for a predetermined duration AJ ⁇ (step S102), thereby delivering a first package of light to the patient P.
  • step S103 the emission of the first wavelength is switched off, and there is a delay period (step S103), which has been found to provide significant benefits, as will be described below.
  • a second package of light is delivered by controlling the radiation emitter assembly to emit light at a second, different, wavelength ⁇ 2 for another predetermined duration ⁇ 2 (step S104), followed by another delay period ⁇ ⁇ 2 (step S105).
  • a third light package is emitted at the third wavelength ⁇ 3 for a period ⁇ 3 (step S106) after which the device is switched off (step S107).
  • many different light irradiation sequences could be implemented, and could include more than the three light packages of the present example.
  • the three specific wavelengths supplied by the device may be selected according to the patient's needs. Generally, one of the wavelengths should stimulate the sympathetic nervous system, another the parasympathetic system and the third have a balancing effect (described below).
  • the present inventors have found that the visible spectrum induces a continuum of effects, ranging from the longest visible wavelength (red) which stimulates the sympathetic system to the shortest (blue/violet) which has the opposite effect, through intermediate wavelengths such as green which achieve balancing of the ANS and increases coherence.
  • the long and short wavelengths are preferably situated at the opposite ends of the visible spectrum.
  • the two wavelengths are spaced by least 100 nm, preferably at least 150 nm, more preferably at least 200 nm, and most preferably around 240 nm.
  • a strong parasympathetic stimulation is desirable (e.g. violet light) but less sympathetic simulation is required and hence orange rather than red light may be selected to partner the short wavelength.
  • the longest wavelength radiation is preferably visible red light, and may have a wavelength in the range 590 to 930 nm, preferably between 640 and 770 nm, more preferably approximately 660 nm +/- 10 nm.
  • the shortest wavelength is preferably blue or violet visible light and may have a wavelength between 350 and 490 nm, preferably between 400 and 425 nm, more preferably approximately 420 nm +/- 10 nm.
  • the intermediate wavelength preferably green visible light and may have a wavelength between 490 and 590 nm, preferably between 500 and 550 nm, more preferably approximately 532 nm +/- 10 nm.
  • the packages of each wavelength can be delivered in any order.
  • stimulating each facet of the ANS with the long and short wavelengths and promoting balancing with the intermediate wavelength overall the ANS is conditioned leading to an improvement in the parameters discussed above. This is analogous to the body undergoing physical training or conditioning in the form of exercise, during which muscles and organs are repeatedly placed under a controlled amount of strain, ultimately increasing their capacity.
  • the presently disclosed irradiation techniques gently stimulate the activity of the ANS, giving rise to improved HRV, increased LF and/or HF frequencies, improved LF/HF ratio and/or improved coherence.
  • preferred light irradiation sequences are:
  • the first light package delivered in step S102 is of the shortest wavelength (e.g. violet) which stimulates the patient's parasympathetic nervous system and encourages a slower heart beat as well as increasing the intensity of high frequency components of the heart beat.
  • the longest wavelength light package (red) delivered in step S104 then stimulates the sympathetic nervous system, having the opposite effect. Variation in the patient's heartbeat is thus encouraged, hence increasing HRV.
  • the intermediate wavelength package (green) of step S106 promotes coherence without undoing the biostimulative effects of the preceding steps. Since this is the end of the sequence, there is no subsequent disruption and for this reason, sequences in which the final light package is of the intermediate wavelength are particularly preferred. However, sequences in which the intermediate wavelength is delivered in the penultimate light package (e.g. sequences (iii) and (iv) above) also retain the balancing effect to a reasonable degree.
  • each light package is determined according to the desired dosage of the corresponding wavelength.
  • the present inventors have found that, for each light package, dosages of between 5 and 200 J, more preferably between 10 and 100 J, still preferably between 10 and 80 J, most preferably between 15 and 60 J are appropriate.
  • Such quantities stimulate the ANS without causing harmful effects (e.g. an overdose of red light is known to risk transitional fatigue, muscle aches and insomnia).
  • each light package could have a duration of around 60 minutes in which case the energy delivered in each light package would be around 54 J.
  • the dosages of each wavelength are the same. However, this is not essential.
  • the dosages of long (red) and short (violet) light will preferably be approximately the same.
  • the sequence delivers a 27 J red light package, a 27 J violet light package and either a 27 J or a 54 J green light package.
  • a green light package also delivered at 15 mW power could have a duration of 120 minutes and hence an energy dosage of 108 J.
  • enhanced effects may be achieved without increasing the dosage of green light by increasing the duration of the light package whilst decreasing the green output wattage, e.g. delivering an energy dosage of 54 J through delivery of 10 mW power over a period of 90 minutes. The additional time that the body has to adjust and respond to the green radiation is believed to be behind the effect.
  • the total light energy dosage of all wavelengths emitted in the light irradiation sequence is preferably between 10 and 500 J, preferably between 20 and 200 J, more preferably between 30 and 150 J, still preferably between 40 and 120 J. These levels of energy have been found to produce the necessary level of stimulus whilst avoiding damage to the skin or other negative side effects.
  • step S103, S105 the insertion of delay periods (steps S103, S105) between light packages during which no light is emitted by the device has been found to provide unexpected benefits.
  • the biostimulative effects of the preceding light package on the body are seen to become amplified.
  • the degree of amplification varies depending on the nature of the preceding light package, but is particularly noticeable where the preceding light package includes shorter wavelength light, e.g. blue, whereby the parasympathetic nervous system is stimulated. Examples will be given below.
  • the delay period may also be referred to in places as a "neutral" period, reflecting the fact that no external stimulus is applied to the body during this time. It should be noted that it is not essential to insert a delay period between every successive pair of light packages (although this is preferred): in some cases, a single delay period might be used to follow for example just one of the wavelengths to particularly reinforce its effects.
  • each delay period should have a duration ⁇ ⁇ ⁇ , ⁇ ⁇ 2 which is sufficiently long. Breaks in irradiation which are less than a minute long (i.e. pulses) tend not to allow the body sufficient time to respond to the radiation after its removal, and hence do not generally lead to any significant amplification effect.
  • each delay period has a duration ⁇ ⁇ 1 , ⁇ ⁇ 2 of at least 1 minute or at least 5 minutes, e.g. between 1 and 120 minutes, more preferably between 5 and 90 minutes, still preferably between 10 and 75 minutes, most preferably between 15 and 60 minutes. Particularly good results have been observed where the delay period has a duration similar or equal to that of the preceding light package, e.g. to within 50%.
  • Additional delay periods can also be used to amplify any given step of a light irradiation sequence.
  • step S102 involves the irradiation of blue light
  • step S104 red light either or both of these steps could be amplified (in addition to the amplification effect of step S103) by applying repeated light packages of the same wavelength (or wavelengths) with intervening delay periods w (i.e. dividing the light package up into multiple shorter light packages).
  • the first (blue) light package could be divided into two steps, each of half the original duration AJ ⁇ .
  • a delay period is inserted between the delivery of the two blue light packages, preferably of a similar duration ( ⁇ ⁇ /2).
  • sequence (i) described above could be repeated any number of times in series, preferably with a delay period inserted between each repetition, as follows (with "V", “R” and “G” denoting violet, red and green light respectively, and dashes ("-") representing delay periods):
  • each step would preferably be reduced compared with the previous examples.
  • each light package may have a duration of 15 minutes.
  • Each delay period may also be 15 minutes long. If the VRG sequence is repeated 4 times, the full irradiation process will take 6 hours.
  • Enhanced ANS flexibility may be achieved by performing different sequences in series. For example, sequences (i) and (ii) mentioned above could be alternated:
  • FIGs 5 and 6 show a second embodiment of a light irradiation treatment device 10 which is designed to be worn by a patient and so is particularly will adapted for use throughout the day or while asleep.
  • the components are mounted in a housing 11, made for example as a plastic moulding.
  • the device should be sufficiently small so as not to be obtrusive or disturb sleep.
  • the housing 11 is provided with a strap 19 for affixing the device 10 to a patient.
  • the strap 19 is an elastic strap provided with a Velcro® fastening 19a although many other suitable arrangements could be envisaged.
  • the device 10 is arranged to be fitted to a patient P for example by strapping the housing 1 1 to the patient's arm (as shown in Figure 5(b)) or leg.
  • any region of the body could be used for this purpose although better results are achieved where close contact between the device and the skin is achievable, e.g. regions where there is little hair, such as the inner arm, are most suitable.
  • one particularly desirable implementation would be to provide the attachment means in the form of a watch strap for wearing around the wrist.
  • Both the housing 1 1 and strap 19 are preferably formed of hypoallergenic materials so as to avoid causing any skin reaction upon contact.
  • the radiation emitter assembly 12 comprises an array of light emitting diodes (LEDs) of which only three are labelled 12a, 12b, 12c for clarity.
  • the array of LEDs is recessed within an aperture 11 a in the housing 11 and arranged such that, when the device 10 is fitted to a patient, the LEDs can directly illuminate the patient's skin. If any components are disposed between the LEDs and the patient, such as a window 16, they should be formed of optically transparent material so as not to affect the wavelengths received by the patient.
  • the LEDs or the transparent window 16, if provided
  • the attachment means e.g. strap 19
  • the strap 19 may comprise a resilient material, such as elastic.
  • the array of LEDs includes at least one LED which emits at a first wavelength, at least one LED which emits at second, different wavelength and at least one LED which emits at a third, different wavelength.
  • the wavebands of the three LED types do not substantially overlap.
  • the number of each type of LED included in the array may be selected according to the desired power output, examples of which will be given below.
  • the longest wavelength radiation will be referred to as “red”, for brevity, but it will be understood that this encompasses any of the possibilities for the longest wavelength discussed above in relation to the first embodiment.
  • the shortest wavelength radiation will be referred to as “blue”, and the intermediate wavelength radiation will be referred to as “green”, but the same considerations apply.
  • the radiation emitter assembly can therefore be controlled to emit red, blue or green light, depending on which LEDs are activated.
  • a controller 14 in the form of a programmed microcontroller as will be described in detail below.
  • Power is supplied by a battery 13 which is preferably rechargeable. Suitable battery types include NiMH or lithium polymer amongst many other possibilities.
  • the battery 13 can be recharged by attachment via a port 13a to a suitable recharging unit (not shown) which may draw its supply from the mains or any other power source (e.g. solar cells).
  • the battery is preferably configured such that it can be fully recharged in a period of less than about 8 hours, so that the user can charge it during the day or overnight for re-use in the next application.
  • the device cannot be charged whilst being worn by a user and/or cannot switch on whilst being charged.
  • This can be achieved by arranging the charging port 13a in a position which cannot be accessed while the device is being worn (e.g. on the same surface as array 12), or through an interlock configured to stop the battery being charged while the device is fitted to a patient.
  • This could involve, for example, a contact sensor as described in more detail below, in conjunction with the controller being adapted to disable charging while the contact sensor indicates that the device is being worn.
  • the energy density of the emitted radiation if the light is delivered at too high a concentration, damage can be caused to the patient's skin. This can be taken into account through selection of the LED's emission angle and arrangement of the LED array such that the light emitted by any two LEDs which will be activated simultaneously does not overlap on the patient's skin, for example.
  • LEDs with wider emission angles e.g. 90 degrees, are preferred especially for shorter wavelengths (e.g. blue LEDs) in order to keep the light density low and also to decrease the apparent brightness of the array should it accidentally be viewed by a user whilst on, thereby reducing the risk of damage to eyesight.
  • the light irradiation sequence to be performed is stored by the controller 14 in an integral or separate memory.
  • This data can be pre-programmed or installed via an optional communications port 14a, which can be a wired or wireless connection such as a USB port, or a WiFi link for example.
  • the light irradiation sequence may be a generic sequence, suitable for treatment of an "average" patient, or may be tailored to the particular patient in question.
  • the sequence comprises three or more light packages of each of the available wavelengths, to be delivered to the patent via the LED array 12.
  • the sequence data will typically include instructions as to which LEDs of the array are to be actuated, when - or in what order - and how (e.g. current levels, PWM information etc).
  • Initiation of the light irradiation sequence can be achieved in a number of ways.
  • the device could be provided with a user interface having a timer or clock which can be set by the user to trigger the first light emission step at a particular time (e.g. 1 1.30 pm GMT).
  • a simplified user interface comprising an on/off switch such as button 17 shown in Figures 3 and 4. Actuation of the switch by the user sends a start signal to the controller 14 in response to which the irradiation sequence is begun as described in more detail below. Deactivation of the switch 17 sends a disable signal to the controller 14, causing the power supply to the radiation emitter assembly 12 to be cut off.
  • the switch 17 is preferably arranged on the same surface of the housing 1 1 as the radiation emitter assembly, as shown in the Figures, such that when the device 10 is fitted to a patient, the switch is located between the housing and the patient's skin and is therefore inaccessible. This prevents the switch being inadvertently actuated by the patient's activities, which could otherwise reset the device.
  • switch 17 provides a further benefit in that it can be used as a detector for determining that the device 10 remains attached to the patient.
  • the brightness of the radiation emitter assembly is such that, if viewed directly by a user, damage could be caused to the viewer's eyes if they deliberately stare at it for a prolonged period of time. Accidental damage is unlikely, due to the low energy intensity. It is nevertheless desirable that the device should be deactivated upon detachment from the patient.
  • the switch 17 By configuring the switch 17 as a resilient switch, the action of fitting the device to the use will itself activate the switch to issue the start signal and, whilst the housing 11 is fitted against the patient, the switch 17 will remain depressed.
  • a patient proximity detector for the same purpose could be provided separately from the on/off switch, either in a similar mechanical format or as an alternative detector type, e.g. a reflective light sensor.
  • a contact sensor such as this could also be utilised in conjunction with the controller to prevent resetting of the device during use. For example, it is convenient for the user to be able to access the on/off switch, or a "start" switch, while the device is being worn and hence in other embodiments this may be provided on a surface of the housing which is not covered in use.
  • the controller may be adapted such that, once a first start signal has been received, if the contact sensor indicates that the device is being worn, a flag will be set such that any further actuation of the switch is ignored by the controller. When the contact sensor detects that the device has been removed from the user, the flag is removed such that the controller will respond to the next actuation of the switch in the usual way, instigating the light irradiation steps.
  • the first light irradiation step may be instigated directly upon receipt of a start signal from the on/off switch. However, it may be preferable to wait for a predetermined delay period after receipt of the start signal before activating the radiation emitter assembly, e.g. 10 minutes or 90 minutes, or longer. This may be to give the patient enough time to fit the device to themselves before irradiation is begun or, if the irradiation is to be delivered while the patient sleeps (as described below), to ensure that the patient has fallen asleep or to postpone delivery of the radiation until the patient has reached a suitable sleep state. Alternatively or in addition, the delay may be in order to align the light packages with selected phases of the patient's sleep cycle. This will also be described further below.
  • the device may include a physiological state sensor 15 for measuring a parameter of the body which reflects the current state of the patient's ANS. This can be used at any time of day but also to determine when the patient falls asleep, and/or which sleep phase they are experiencing.
  • the sensor 15 can monitor any suitable parameter of the patient.
  • a motion detector such as an accelerometer could be used to sense movements of the patient which are indicative of the transition from awake to asleep.
  • An ECG or a pulse monitoring system to measure HRV, or an EEG to identify specific brainwaves associated with the transition between different physiological states (e.g. alert or drowsy), may alternatively be used. Pattern recognition could be performed on the output signal to identify when the patient has entered a certain state and a trigger signal issued upon which the controller may begin or continue with a particular step of the irradiation sequence.
  • the light may be emitted continuously or as a series of pulses, under the management of controller 14.
  • PWM pulse width modulate
  • the pulse frequency of around 0.1 Hz leads to resonation between the pulses of light and natural oscillations in the body's blood pressure known as Mayer waves. This has been found to enhance the effect of the red irradiation on the autonomic nervous system and stimulate the sympathetic nervous system still further.
  • the blue light package is delivered as continuous wave (unmodulated) radiation ("CW").
  • CW continuous wave
  • the dosage of each light package needs to be controlled to achieve the desired effects.
  • the amount of energy delivered can be fixed through design of the radiation emitter assembly and/or appropriate control by the controller.
  • the desired energy dosages are achieved by forming the LED array 12 of one red LEDs, rated at 15 mW optical output when operating at a forward current of 20 mA, and one blue LED also rated at 15 mW when operated at the same forward current and one or two green LEDs with the same rating at the same forward current.
  • the particular irradiation sequence (i) described above with reference to Figure 4 is a preferred option due to the intermediate wavelength being delivered last, as already explained. However, the order in which the long and short wavelengths are delivered has also been found to influence the overall result achieved by the irradiation.
  • each wavelength may be delivered by one LED having a power of 15 mW in which case the duration of each light package may be 30 minutes (assuming operation at 100% duty cycle)
  • FIG. 7 is a flow diagram illustrating steps of this light irradiation sequence in more detail, showing the process followed by the controller 14.
  • the light irradiation sequence S210 includes three light irradiation steps of the three different wavelengths (long, intermediate and short), scheduled according to predetermined timings.
  • the controller waits for a start signal to be received, for example from on/off switch 17.
  • the light irradiation sequence S210 may be initiated immediately by moving directly to step S202.
  • the processes shown in Figures 8a and/or 8b may be implemented to more accurately align the light packages with the patient's physiological state.
  • the controller waits for a predetermined delay time T D to elapse, after which the process continues at step S202.
  • the delay interval could be to enable the patient to fit the device before the irradiation will begin.
  • the delay interval may be to allow the patient to fall asleep before beginning irradiation, the delay time T D may be around 10 minutes.
  • the duration of the delay may be designed to postpone the delivery of the light packages until the disturbed sleep cycles have passed, so as to avoid causing any further disruption.
  • a delay of 90 minutes would postpone the light irradiation sequence until the patient's second sleep cycle (for an average patient), and a delay of 180 minutes would postpone delivery until the patient's third cycle.
  • the delay duration T D may be user-selectable, or the device could be equipped with multiple light irradiation sequences with different built in delay times, from which the user can choose (see below).
  • An appropriate delay period T D can therefore be used to align delivery of the light irradiation sequence with this part of the patient's night sleep.
  • the device could wait until a preselected time is reached, e.g. 9 a.m. GMT, based on a clock signal.
  • step S207 the controller waits for a trigger signal from a sensor such as sensor 15 described above.
  • a trigger signal from a sensor such as sensor 15 described above.
  • the trigger could indicate that the patient has fallen asleep, or could be indicative of the patient reaching a particular sleep phase or depth of sleep, either of which can be used to postpone delivery of the light packages until the most appropriate time, for the same reasons as already mentioned.
  • the system can proceed to step S202.
  • Step S202 is the delivery of the first light package of the light irradiation sequence S210.
  • the controller actuates the radiation emitter assembly to emit light at a first wavelength for a period AJ ⁇ .
  • This is preferably a stimulative light package, e.g. blue or violet light for stimulating the patient's parasympathetic nervous system, and in one example the radiation parameters are ⁇ 420 nm, AJ ⁇ ⁇ 30 mins.
  • step S202a After completing delivery of the first light package, the blue light is switched off and there is a delay period (step S202a) during which no light is emitted. As described in relation to Figure 4, this amplifies the effects of the preceding step, and in the present embodiment a delay duration, ⁇ ⁇ 1 , of around 15 minutes is employed. The present inventors have found that the amplification effect of the delay period is particularly effective when the preceding light package stimulates the parasympathetic nervous system (e.g. blue light).
  • the process moves to step S203 in which the second light package is delivered.
  • the controller actuates the radiation emitter assembly to emit light at a second wavelength ⁇ 2 for a period ⁇ 2 .
  • the second light package is also preferably a stimulative light package, designed to stimulate the other part of the ANS which was not stimulated during the first step.
  • the second light package is of red light and the radiation parameters may be ⁇ 2 ⁇ 660 nm, ⁇ 2 ⁇ 30 mins.
  • the energy dosage of the second wavelength delivered during the second light package is preferably approximately the same as that of the first light package.
  • a second delay period is enacted in step S203a. Again, this amplifies the effect of the preceding light package.
  • the delay duration ⁇ ⁇ 2 in this example is also around 15 minutes.
  • step S204 the controller actuates the radiation emitter assembly to deliver a third light package.
  • the radiation emitted during this step is of an intermediate wavelength ⁇ 3 , which is in between the first and second wavelengths and ⁇ 2 , e.g. green light.
  • the light package parameters in this example are ⁇ 3 ⁇ 532 nm, ⁇ 3 ⁇ 30 minutes. This has a balancing effect on the ANS, promoting rhythm and increasing coherence, whilst not undoing the stimulative effects of the preceding light packages (and delay period(s)).
  • step S210 On completion of the light irradiation sequence S210, the system moves to step S205 in which the radiation emitter assembly is switched off (having the effect of a further delay period).
  • the green light package delivered in step S204 is the final radiation emitted, resulting in increased HRV and ANS activity (across all frequencies), and good coherence. Whilst the effects will be temporary, repeated application of the treatment can lead to a lasting improvement.
  • the sequence S201 to S205 can be repeated multiple times (or followed by one or more different sequences) in quick succession if desired, although in this case it may be desirable to reduce the dosage delivered in each step so that the overall energy dosage of each wavelength delivered during the full session is not significantly altered.
  • Figure 9 illustrates the activation of each wavelength over time for the same example, including the delay periods S202a and S203a.
  • Plot (a) shows the intensity I output at the shortest wavelength (blue light)
  • plot (b) shows the intensity output at the longest wavelength ⁇ 2 (red light)
  • plot (c) shows that of the intermediate wavelength ⁇ 3 (green).
  • the system may wait a predetermined time or for a trigger signal before beginning light emission but in this example, the irradiation cycle begins immediately.
  • the radiation emitter assembly is actuated to emit blue light at intensity for a period AJ ⁇ .
  • the controller stops the emission of blue light and, for a period ⁇ ⁇ ⁇ , no radiation is emitted.
  • the controller controls the radiation emitter assembly to irradiate the patient with red light at intensity l 2 for a period ⁇ 2 .
  • the red light is switched off for another delay period of duration ⁇ ⁇ 2 during which no radiation is emitted.
  • the controller commences the delivery of the final light package by activating the radiation emitter assembly to emit green light at intensity l 3 for a duration ⁇ 3 .
  • This completes the light irradiation sequence and at t (T s + AJ ⁇ + ⁇ ⁇ 1 + ⁇ 2 + ⁇ ⁇ 2 + ⁇ 3 ), the radiation assembly is switched off. Thereafter, in this example, the device preferably emits no light irradiation until directed to do so by the user (e.g. another start signal is received).
  • the amount of energy delivered during each step is illustrated by the areas under the plot EL E 2 , E 3 , and in this example the device is configured as described above such that Ei ⁇ E 2 ⁇ E 3 , although if desired the dosage of the intermediate wavelength may be higher.
  • this sequence has been found to have a stimulative effect on the body and is best employed when the patient is required to be alert.
  • the short and long wavelengths are delivered in the reverse order (sequence (ii))
  • the opposite effect is observed, promoting body recovery and sleep preparation.
  • it is preferred that such a sequence would be delivered towards the end of the patient's waking day or whilst they are asleep.
  • Such a sequence could be delivered in the same way as described with reference to Figures 7 to 9, by emitting red light during ⁇ and blue light during ⁇ 2 .
  • the device is equipped with the ability to deliver both sequence (i) and sequence (ii) at different times. Examples of how multiple sequences such as these may be stored in the device and initiated will be given below.
  • the light irradiation sequence performed in the above embodiment delivers approximately equals dosages of at least the two stimulative wavelengths (red and blue) to the patient. This is appropriate for a significant proportion of patients and in particular those whose autonomic nervous system (ANS) is reasonably well balanced between sympathetic and parasympathetic. However, it may be the case that the patient has a tendency towards either sympathetic or parasympathetic activity, in which case it may be appropriate to adjust the light irradiation sequence so as to improve the balance of their ANS function and promote activity in one part of the ANS more than the other. This may be achieved by retaining the same three- step sequence but weighting the dosage of each wavelength according to the patient's requirements.
  • ANS autonomic nervous system
  • the patient may be appropriate to deliver more blue radiation than red during the light irradiation sequence.
  • This can be achieved by either increasing the energy of the first (blue) light package, or by reducing the energy of the second light package (red). This might be done by changing the number of LEDs activated during an irradiation step, changing the duration of irradiation or adjusting PWM parameters such as the duty cycle, for example.
  • the tendency of the patient towards sympathetic or parasympathetic activity may be such that the dosage of one or other of the wavelengths may be reduced to zero.
  • the red light package may be omitted entirely to avoid exacerbating the problem.
  • the light irradiation sequence could comprise a blue light package followed by a delay period and a green light package. If the parasympathetic activity requires further enhancement, the blue light package could be repeated with intervening neutral intervals, as described above. For example, the sequence could be: "blue - delay - blue - delay (repeated as desired) - green".
  • red and blue light are not to be equal, it is preferred that it is the amount of blue light (shorter wavelength, more generally) that is adjusted, whilst the red dose is preferably kept constant. This is because shorter wavelengths such as blue light have a more profound biological effect on the organism, than applying the same dosage of red or green light. As such, even if equally stimulating effect for the sympathetic or parasympathetic nervous systems is desired, it may be necessary to use lower doses of blue light.
  • the dosages of each wavelength could also be adjusted while maintaining the balance between them. For example, it may be desirable to reduce the total irradiation dosage, possibly as an intermediate step when either introducing or withdrawing use of the device.
  • each of the above embodiments only one of the available wavelengths is used in each light package (although some overlap at transitions where there is no delay period is acceptable).
  • the sympathetic and/or the parasympathetic nervous systems are stimulated individually, one after the other.
  • the present inventors have found that certain effects can be achieved through the application of light packages in which both long (e.g. red) and short (e.g. blue) wavelengths are delivered simultaneously. This is surprising since the opposing effects caused by each wavelength might be expected to cancel one another out.
  • initial tests have shown that the level of stimulation is increased. It is hypothesised that this may be due to the increased strain placed on the organism by the competing stimulants, with reflective counter-regulation during the delay period.
  • the degree of simulation can be so high that the use of such "dual wavelength" light packages is not a preferred option.
  • Figure 10 is a flow diagram showing the steps followed by the controller 14 implementing a light irradiation sequence in a third embodiment which makes use of such a combined light package.
  • the initiation of the sequence (step S301) is the same as described with respect to Figure 7, and the process may or may not encompass the steps described above with respect to Figure 8.
  • the first light package is output by emitting both long and short wavelength light (e.g. red and blue) concurrently.
  • the radiation parameters may be ⁇ 660 nm, ⁇ 2 ⁇ 420 nm, ⁇ ⁇ 30 mins.
  • the dosage of red light received during step S302 will be equal to that of blue light, and this is appropriate for many patients.
  • the relative doses of each wavelength may be adjusted accordingly, either by emitting the two wavelengths at different intensities and/or by adjusting the time for which each is emitted such that the concurrent "red + blue" light package is either preceded or followed by a light package of one or other of the stimulative wavelengths.
  • Figure 10 includes optional light package S303, which follows on directly after the delivery of the red + blue light package (S302) is complete.
  • the controller may switch from step S302 to step S303 by turning off one or other of the wavelengths and continuing emission of the other.
  • the duration of step S303 will depend on the dosage requirements but could for example be 10 minutes. If the red dose is to be higher than the blue dose, it is preferred that the red-only light package precede the "red + blue" light package (i.e. be inserted before step S302). This is because the subsequent delay period has been found to give rise to greater amplification effects when it follows a blue light package or a "red + blue” light package than red light alone.
  • Steps S304, S305 and S306 correspond to steps S203a, S204 and S205 described with respect to the previous embodiment.
  • the amplification effect of the delay period S304 could be achieved instead (or supplemented by) implementing any or all of the light package delivery steps (S302, S303 and S305) in the form of multiple light packages of the same wavelengths, spaced by neutral intervals, in the manner described above.
  • the sequence could be: "(red + blue) - delay - (red + blue) - delay (repeat as necessary) - green".
  • Figure 11 illustrates the activation of each wavelength over time for the Figure 10 embodiment in the same manner as Figure 9, described above, and using the same notation.
  • the solid trace represents the intensity of blue radiation where optional step S303 is not performed
  • the broken-line trace represents the case where step S303 is implemented in the manner described above.
  • the duration of the subsequent delay period ⁇ ⁇ 1 might be shortened so that the overall duration of the light irradiation sequence is unchanged (as shown in Figure 1 1), or the full delay duration may be retained, in which case the start of the intermediate light package (step S305) would be delayed by a period of time equal to the duration of step S303, ⁇ 2 .
  • FIG. 12 a to 12 g Each Figure is a plot showing the patient's frequency spectrum accumulated during delivery of a radiation package or neutral (delay) period as defined below. It should be noted that each plot represents the total power at each frequency accumulated over the full duration of the light package or neutral period in question, rather than a snapshot of the patient's electrical activity.
  • the radiation was applied to the patient's arm using a device substantially as described above with reference to Figures 5 and 6. For convenience, the test was carried out during the day, while the patient was awake. Whilst in some embodiments it is preferred that the treatment be applied while the patient sleeps, the trends revealed by the present daytime tests should be the same.
  • the frequency spectra were obtained by monitoring the patient's heart beat using an infrared LED pulse sensor, which was fixed to the patient's earlobe, and a software package such as the "EmWave® Desktop" produced by HeartMath LLC for performing power spectrum analysis of the heart beat.
  • Figure 12a is a baseline measurement showing the patient's frequency spectrum before the application of any radiation through the device. The patient was exposed to ambient lighting conditions in the usual way.
  • the x-axis represents frequency in units of Hz
  • the y-axis the amplitude or power of each frequency component, in ms 2 .
  • frequencies between about 0.04 and 0.15 Hz are predominantly sympathetic whereas frequencies between about 0.15 Hz and 0.4 Hz are parasympathetic.
  • VLF very low frequency
  • Figure 12c shows the patient's frequency spectrum over 20 minutes of a neutral period imposed after the delivery of the above mentioned red light package has finished (i.e. during a delay period of duration 20 minutes). It will be seen that the peaks at 0.025 Hz and 0.075 Hz are no longer as prevalent, and indeed have decreased slightly in intensity, but at the higher sympathetic frequencies there is an increase in activity: for example, around 0.1 Hz, the intensity has increased to around 30.
  • Figure 12d shows the patient's frequency response during irradiation with a short wavelength such as blue. Note that in the tests, this light package was delivered a about 20 minutes after the red light ceased to be applied; thus Figure 12d should be compared against the patient's baseline in Figure 12a.
  • Figure 12f illustrates the patient's response to a combined package of red and blue light delivered concurrently, as in the Figure 10 embodiment.
  • the sympathetic frequencies it will be seen that there is a significant increase across the range between 0.04and 0.15 Hz range, not only at the original peak frequencies but also particularly at the higher end of the sympathetic range. For example, between 0.1 and 0.15 Hz, the intensity is increased from about 18 (baseline) to about 40. The effect is also significantly more pronounced than that achieved by red light alone (cf. Figure 12b).
  • the irradiation sequence takes place while the patient sleeps and this may be the extent of any alignment between the light irradiation sequence and the patient's sleeping cycles.
  • additional benefits can be achieved if some or all of the light packages are delivered in alignment with certain phases of the patient's sleep. For instance, if the patient suffers from a disturbed sleeping pattern, the light irradiation could additionally be used to entrain the patient's sleep cycles by carrying out the stimulation of the patient's sympathetic nervous system at times which correspond to phases of the sleep cycle which are predominantly sympathetic, and likewise stimulating the patient's parasympathetic nervous system at times corresponding to phases of the sleep cycle which are predominantly parasympathetic.
  • the patient sleeps robustly it may be possible to achieve enhanced HRV effects by reversing the alignment, so that the sympathetic nervous system is stimulated during sleep phases when the parasympathetic nervous system is most active, and vice versa.
  • this increases the risk of disrupting sleep so would preferably be performed during the deepest part of the patient's sleep (e.g. middle of the night).
  • a patient In a typical night's sleep, a patient should experience around 4 or 5 sleep cycles, each consisting of a non-REM phase followed by a REM phase. Studies have shown that, in healthy human subjects, in the first sleep cycle during a night, the non-REM phase has a duration of approximately 80 minutes (e.g.
  • wavelengths such as red which stimulate the patient's sympathetic nervous system encourage increased and accelerated metabolism and promote stage 1 non- REM and REM sleep.
  • Intermediate wavelengths such as green do not strongly promote particular sleep phases and therefore can be delivered at any time, but so as to avoid conflict with the patient's intrinsic ANS activity, are preferably delivered during non-REM stage 2 sleep.
  • selected sleep phases can be enhanced and/or their sleeping pattern can be entrained to follow the desired cycle whilst still achieving the improvement in HRV that is sought.
  • the delivery of the light packages in alignment with the patient's sleep cycles can be achieved in a number of ways.
  • the light irradiation sequence may make use of pre-determined timings (e.g. using a clock which may be relative to the switching-on of the device or to a signal representing the actual time - e.g. GMT or BST, maintained by the controller) which are based on the "generic" human sleep cycle, described above. However in other examples they may be based directly on the sleep cycle of the patient in question.
  • the device may include means for obtaining feedback from the patient such as physiological sensor 15 mentioned above, in which case the light irradiation sequence may be scheduled based on the sleep state of the patient (determined from the sensor signal), without pre-determined timings (or in combination with predetermined timings).
  • step S103 encourages a change in the patient's autonomic nervous system from predominantly sympathetic to predominantly parasympathetic, leading the patient's sleep cycle to follow suit and switch from non- REM stage 1 through non-REM sleep stage 2 to non-REM stages 3 and 4.
  • the light irradiation sequence could comprise the same light packages delivered in the reverse order, e.g. first emitting the shorter wavelength to coincide with the patient's first non-REM stages 3 and 4 sleep phase, then emitting the longer wavelength to coincide with the change to REM sleep which completes the first sleep cycle.
  • the light packages may all be delivered to coincide with sleep phases from the same sleep cycle, or could encompass phases from adjacent sleep cycles if preferred.
  • a delay period may be included in the sequence, this may be arranged to begin or end at the time of the transition from one phase to another.
  • the subsequent green light package may be emitted at any time since intermediate wavelengths are less disruptive, but most preferably is arranged to coincide with a subsequent non-REM stage 2 phase, typically after a delay period.
  • the light packages could be aligned with any selected sleep phases, and the selected phases need not form part of the same sleep cycle.
  • the sequence to be delivered is: blue - red - green
  • the first light package could be arranged to coincide with the non-REM stages 3 and 4 phase of the patient's first sleep cycle, the second light package with the patient's REM phase of the second cycle, and the third with the ensuing non-REM stage 2 phase.
  • the duration of each light package is predetermined. For maximum sleep entrainment effect, the duration could be approximately equal to that of the corresponding sleep phase, or less so that a subsequent delay period can be inserted within the same sleep phase.
  • the duration of the longer wavelength light package may be approximately 5 minutes, corresponding to that the first half of a typical 10 minute long REM or non-REM stage 1 sleep phase.
  • the wattage of the radiation emitter assembly may be adjusted so that the desired dosage known to be effective in terms of HRV improvement is still delivered within the timeframe.
  • the longer wavelength package is delivered as the first step, its duration may be around 15 minutes, designed to irradiate the patient for a period before they fall asleep (approx. 10 minutes) plus the first 5 minutes of the first sleep phase (non-REM stage 1 , approx. 10 minutes), followed by a 5 minute delay period.
  • the duration of an ensuing shorter wavelength light package may be approximately 35 minutes, corresponding to that the first half of a typical non-REM stages 2, 3 and 4 phase (70 minutes). In other embodiments, however, the delivery of each package of light may continue for more or less than half of the relevant sleep cycle. Further, whilst it may be beneficial to align certain light packages with the patient's sleep cycle, it is not necessarily important to do so for all of the light packages in a sequence, particularly the green light package. An example of such an embodiment will now be described with reference to Figures 13 and 14.
  • Figure 13 is a flow diagram showing a process performed by the controller when implementing a light irradiation sequence based partially on feedback from the physiological state sensor 15, which here is used to ascertain the patient's sleep state.
  • the physiological state sensor 15 outputs a signal S s (here, indicative of the patient's current sleep state), from which it can be deduced which sleep phase they are experiencing.
  • the sensor 15 takes the form of a motion detector but in other cases this could be replaced, or used in combination with, other detectors such as electrodes for detecting electrical activity of the heart and/or the brain, a pulse monitor or a breath monitor.
  • a processor may be used to perform power spectrum analysis on the HRV to thereby determine the activity of the ANS and hence the current sleep phase.
  • the brainwave activity would also give an accurate measure for the transition from one sleep phase into the next.
  • the sensor 15 could be disposed outside the housing 1 1 if necessary - for instance a photo-optic sensor for fitting to the patient's finger or earlobe could be linked to the device by wired or wireless means for detecting the patent's pulse.
  • step S401 The process begins at step S401 when a start signal is received from the user, e.g. by turning the device on.
  • the controller then waits for a trigger signal from the sleep state sensor in step S402. This could be any selected feature, such as a sleep phase transition, in the physiological state signal but is preferably indicative of the patient falling asleep.
  • a trigger signal from the sleep state sensor in step S402. This could be any selected feature, such as a sleep phase transition, in the physiological state signal but is preferably indicative of the patient falling asleep.
  • the controller actuates the light emitter assembly to begin emitting light at the first wavelength ⁇ , e.g. approx. 660 nm (red).
  • the device continues to emit red light for a period ⁇ e.g. 5 minutes, at which point the emitter is switched of (step S404).
  • step S405 No light is emitted until a transition in the sleep state signal is detected at step S405, and this period therefore is a delay period of unfixed duration.
  • the detected signal change may be indicative of the patient transitioning from non-REM stage 1 sleep (predominantly sympathetic) to non-REM stages 2, 3 and 4 sleep (predominantly parasympathetic).
  • the duration of the delay ( ⁇ ⁇ 1 ) would vary but would typically be around 5 minutes.
  • the controller actuates the light emitter assembly to begin emitting light at the second wavelength ⁇ 2 , e.g. approx 420 nm (blue) for a duration ⁇ 2 .
  • step S407 the blue light emission is ceased in step S407.
  • ⁇ 2 may be around 30 minutes for example and so the blue light package would be delivered during only a portion of the patient's non-REM stages 2, 3 and 4 phase.
  • step S408 next there is no light emission for a delay period of duration ⁇ ⁇ 2 , e.g. 40 minutes (step S408). Again, this is controlled based on predetermined timings and, at the conclusion of the delay period, in step S409, an intermediate light package is delivered at a third wavelength ⁇ 3 , e.g. 532 nm (green) for a predetermined duration ⁇ 3 (e.g. 60 minutes). This is the final light package and the device therefore switches off in step S410.
  • ⁇ 3 e.g. 532 nm (green) for a predetermined duration ⁇ 3 (e.g. 60 minutes).
  • Figure 14 shows plots of (i) the physiological state signal S s (here in terms of the amount of sympathetic activity detected), and (a to c) the light output at each of the three wavelengths.
  • the sleep state signal S s meets criteria considered to be indicative of the patient falling asleep (e.g. a threshold value is crossed).
  • the red LEDs are activated, although there may be a short time lag.
  • the red LED(s) are switched off such that no radiation is emitted. This continues until the value of S s changes in a manner indicative of a transition between the sleep phases from non-REM state 1 to non-REM states 2, 3 and 4.
  • the duration of the first delay period ( ⁇ ⁇ 1 ) is not pre-determined but rather configured dynamically in response to the real-time behaviour of the patient.
  • the light packages have predetermined durations. In other cases, the duration of one or more of the light packages could be based solely on the physiological signal rather than on timings.
  • Similar feedback-based techniques can be used to implement any of the light irradiation sequences described in the previous embodiments, whether or not the irradiation is to be applied during sleep.
  • a person's ANS activity also varies throughout the day and this can be used to control the irradiation is the same way.
  • each of the above embodiments describes the light irradiation treatment device as performing a single light irradiation sequence.
  • the device can be used to perform a number of different light irradiation sequences, preferably upon selection by the user. This could be achieved using the device described above by installing a new light irradiation sequence, for example by receiving data via the disclosed communications means and writing over the existing sequence stored in memory.
  • the device is configurable to perform any of a plurality of preprogrammed light irradiation sequences.
  • FIGS 15 and 16 illustrate a further embodiment of a light irradiation device 20 implemented in this way.
  • the device 20 is designed to be worn around the patient's wrist, in a manner similar to a watch.
  • the housing 1 1 is mounted on a strap 19, the ends of which include a fixing such as VelcroTM or a buckle for securing them together.
  • the front surface of the device 20, shown in Figure 12(a) faces away from the patient's skin when in use.
  • This carries a user interface 17 made up of three input buttons 17a, 17b and 17c, as well as a display 17d such as a LCD or a backlit LCD.
  • the input buttons may comprise for instance, a on/off switch 17a, for issuing a start signal to the device, a communication button 17b, for controlling the device's communications port (e.g. instigating communication with an external device), and a mode selection button 17c, for selecting between different modes offered by the device.
  • the display 17d can be used to display the currently selected mode, for instance.
  • the device also includes a charging port 13a and a communications port 14a as previously described.
  • the light emitter assembly 12 On the rear face of the device 20, which faces the patient's skin in use, the light emitter assembly 12 is arranged. As in the previous embodiments, here this comprises a plurality of LEDs, some of which emit red light and others blue and others green. Also shown are two contact sensors 18, such as photodetectors or resistance detectors, for sensing whether the device is fitted to the patient and issuing a disable signal to the controller if not.
  • Figure 16 shows the device 20 connected to an external device 30, such as a computer.
  • the connection can be wired or wireless, and may be direct (e.g. a USB connection) or via a network such as an intranet, internet or phone network.
  • the external device can be provided with software for configuring one or more light irradiation sequences (e.g. by selecting what light packages should be delivered and parameters such as energy dosages and/or timings) and uploading them to the device.
  • the external device 30 could be a read only memory, or a memory stick or hard drive, containing light irradiation sequences which the device downloads onto its memory upon connection.
  • Figure 17 is a schematic block diagram showing interactions between the device controller 14 and selected components in this embodiment.
  • the controller 14 includes a memory 21 configured to store at least one and preferably a plurality of light irradiation sequences L.
  • the memory is depicted as storing five sequences L 2 , L 3 , L 4 , and L 5 .
  • the stored light irradiation sequences could include any selection of the sequences described above with respect to the previous embodiments. For instance, the table below summarises an exemplary set of light irradiation sequences that could be stored in memory:
  • sequences l_i and L 2 correspond to that described above with reference to Figure 7 and may be appropriate for a large proportion of patients in the morning and in the afternoon, respectively.
  • the controller may therefore be configured to perform any of these three sequences in its default setting.
  • Sequence L 3 is an example of a sequence weighted towards parasympathetic stimulation, which may be appropriate for a patient with natural bias towards sympathetic activity.
  • the duration of the blue light package is longer than that of the red.
  • the green light package is also significantly longer to promote balancing still further. It will be appreciated that it is not necessary to take all of these measures (weighted red/blue doses, shortened or omitted delay periods and longer green periods) to account for such a bias - any one or more of these measures might be appropriate.
  • Sequence L 4 is an example of a sequence in which the intermediate light package (green) is the penultimate rather than the last light package of the sequence.
  • Sequence L 5 is scheduled utilises feedback from a sleep state sensor 15, as described with reference to Figures 13 and 14 above.
  • a sleep state sensor 15 as described with reference to Figures 13 and 14 above.
  • many other light irradiation sequences could be devised and it should be appreciated that the set shown in the above table could be expanded on or reduced.
  • the controller includes a mode selector 22, typically implemented as programming.
  • the sequence selected by the mode selector is used by the controller 14 to control the radiation emitter assembly 12.
  • the mode selector 22 could receive input from the user interface 17, in particular mode selection button 17c, which could be operated by the user to choose one of the sequences l_i to L 5 to be performed, e.g. by scrolling through a list shown on the display 17d. This is particularly appropriate where set of stored sequences includes those suited to different patients' needs and the patient is selecting the mode most suited to theirs.
  • any one patient progresses through treatment, it may be necessary to change the light irradiation sequence they receive.
  • a patient starting treatment with an extreme tendency towards parasympathetic ANS activity may require a heavily weighted irradiation sequence for a first treatment period (e.g. a number of days or weeks). Once this has had an effect, their ANS activity should become more balanced in which case a less heavily weighted sequence may be appropriate. In due course, they may move on to a substantially equally balanced sequence such as l_i . Switching between the different sequences could be performed manually by the user via the mode selection button at the appropriate times, possibly under instruction from a specialist or in accordance with a course of treatment that has been prescribed.
  • a treatment programme TP can be stored in memory 21.
  • the treatment programme comprises instructions as to which irradiation sequence L should be performed. This may be based on a clock or calendar, or on a count of the number of treatment cycles that have been performed, as shown in the following example, TP1 :
  • the treatment program could be based on feedback from the patient, obtained via the sleep state sensor or from the frequency domain power analysis of heart rate variablity. For instance, this can be used to monitor their sleep state throughout each use of the device (or at intervals) to determine whether certain criteria have been met, e.g. whether the balance between sympathetic and parasympathetic ANS activity has improved by a certain amount.
  • the mode selector can switch between light irradiation sequences accordingly.
  • Treatment programmes can be downloaded to the memory 21 via the communications port 21 in much the same way as the light irradiation sequences themselves. More than one treatment programme could be installed in the device if desired, and additional selection means provided for selecting between them.
  • treatment programs need not specify a long-term change in the sequences applied but could instead specify a schedule of irradiation sessions repeated on a daily, weekly or monthly basis.
  • a treatment program could specify the outputting of sequence l_i each morning and sequence L 2 each afternoon.
  • the treatment program could specify a time at which each sequence should be performed and could initiate irradiation automatically upon reaching that time without involvement from the patient (who may wear the device continuously).
  • the device could wait for a start signal from the patient and in response determine what time of day it is (e.g. whether the current time falls within a predetermined acceptable range for each sequence) and initiate the appropriate sequence for that time of day (e.g. I_i or L 2 ).
  • the treatment program could involve both a daily, weekly or monthly repeated schedule and a long-term migration effect if desired.
  • the treatment programme(s) could be hosted on an external device 30 such as a computer, and communicate with the controller via communication port 14a to provide instructions to the mode selector 22.
  • Data such as the physiological state signal from sensor 15 can also be output to the external device 30 via communications port 14a as an input to the treatment programme if desired.
  • the device may also be configurable to operate in a monitoring mode, in which no light irradiation sequence is output.
  • the physiological state signal S s from sensor 15 can be stored in memory for use in analysing the patient's sleep cycle. This could be used for instance at the beginning of treatment to diagnose problems and to decide upon suitable treatment, and/or at intervals during treatment to determine the progress of the treatment.
  • the recorded signal could be output to an external device via the communications port 14a for analysis by suitable software or by a specialist.
  • the outcome can be used to formulate one or more light irradiation sequences and/or treatment programmes suitable for the patient's needs, which can then be transferred to the device memory 21 for use in the processes described above.
  • the device may also be provided with additional light irradiation sequences of which the primary objective is sleep entrainment rather than HRV improvement (although the irradiation will still intrinsically affect the ANS and therefore will still affect HRV).
  • additional light irradiation sequences of which the primary objective is sleep entrainment rather than HRV improvement (although the irradiation will still intrinsically affect the ANS and therefore will still affect HRV).
  • the light irradiation sequence i.e. that from non-REM stage 1 to non- REM stages 2, 3 and 4 in the first sleep cycle.
  • the light irradiation sequence i.e. that from non-REM stage 1 to non- REM stages 2, 3 and 4 in the first sleep cycle.
  • a different sleep phase transition can be treated.
  • the light irradiation sequence can include one or more repetitions of the described irradiation steps (possibly with modified parameters, particularly the duration of each) in order to influence two or more of the patient's sleep cycles or to enhance the effect through repetition of the treatment pattern during the same treatment session.
  • the light irradiation sequence could include any number of light packages.
  • the present inventors have found that a sequence of three light packages produces good sleep entrainment results, and in the present embodiment the light emitter assembly 12 is therefore controlled to output a further light package after the first and second described in the first embodiment.
  • the additional light package is scheduled to align with the last phase of the patient's first sleep cycle, which is a REM phase.
  • the additional light package involves the emission of red light, which will typically be of the same wavelength as that emitted in the first light package so that the same LEDs can be used (although this is not essential).
  • scheduling of the light irradiation sequence is achieved through the use of pre-determined timings, in much the same way as the first embodiment.
  • FIG 18 is a flow diagram showing the process followed by the controller 14 in a further embodiment, in which the light irradiation sequence S510 includes three light irradiation steps scheduled according to predetermined timings.
  • the controller waits for a start signal to be received, for example from on/off switch 17.
  • the light irradiation sequence S510 may be initiated immediately by moving directly to step S502.
  • the processes shown in Figures 8a and/or 8b may be implemented to more accurately align the light packages with the patient's sleeping pattern.
  • Step S502 is the delivery of the first light package of the light irradiation sequence S510.
  • the controller actuates the radiation emitter assembly to emit light at a first wavelength for a period ⁇ .
  • this first light irradiation step takes place throughout the patient's first non-REM stage 1 sleep phase and so in one example the radiation parameters are ⁇ 660 nm, ⁇ ⁇ 20 mins (which includes approx. 10 minutes prior to the patient falling asleep).
  • the process moves to step S503 in which the second light package is delivered.
  • the controller actuates the radiation emitter assembly to emit light at a second wavelength ⁇ 2 for a period ⁇ 2 .
  • the second light package corresponds to the patient's first non-REM stages 2, 3 and 4 sleep phase and so the radiation parameters may be ⁇ 2 ⁇ 420 nm, ⁇ 2 ⁇ 70 mins, for example.
  • the controller actuates the radiation emitter assembly to deliver a third light package, to coincide with the REM sleep phase which completes the patient's first sleep cycle.
  • the radiation emitted during this step is of a wavelength ⁇ *, which should be similar or identical to that emitted during the first irradiation step, i.e. red.
  • this wavelength it is preferable for this wavelength to be equal to the first wavelength (e.g.
  • the system moves to step S505 in which the radiation emitter assembly is switched off.
  • Figure 19 illustrates the activation of each wavelength over time for the same example.
  • the upper plot shows the intensity I output at the longer wavelength and ⁇ ⁇ * (red light), and the lower plot shows that of the shorter wavelength ⁇ 2 (blue).
  • the patient's sleep phases are indicated by sections P 2 , P3, all of which form part of their first sleep cycle (SCi).
  • SCi first sleep cycle
  • the system may wait a predetermined time or for a trigger signal before beginning light emission but in this example, the irradiation cycle begins immediately.
  • the radiation emitter assembly is actuated to emit red light at intensity for a period ⁇ 1.
  • the red light may be pulse width modulated, e.g. operating at a pulse frequency of approx. 0.1 Hz and a duty cycle of around 50%.
  • the first light emission step begins before the patient falls asleep, which is indicated by T*.
  • the first sleep phase is non-REM stage 1 sleep.
  • the controller stops the emission of red light and controls the radiation emitter assembly to irradiate the patient with blue light at intensity l 2 for a period ⁇ 2 .
  • the blue light is switched off and the red light switched back on to support the patient's transition from non-REM to REM sleep (P 3 ), for a final duration ⁇ 3 .
  • the amount of energy delivered during each step is illustrated by the areas under the plot Ei , E 2 , E 3 , and preferably the device is configured as described above such that (Ei + E 3 ) ⁇ E 2 .
  • the radiation assembly is switched off.
  • the device preferably emits no light irradiation.
  • Figure 20 shows an example of a light irradiation sequence which could be performed by the device in another embodiment, where the duration of each light package is altered to change the energy dosage (which might be for any of the purposes described above), using plots corresponding to those of Figure 19.
  • the light irradiation steps do not have the same duration as the corresponding sleep phases.
  • the process executed by the controller is the same as that described above with reference to Figure 18, except for the implementation of different pre-determined timings in accordance with the modified light irradiation sequence.
  • the first package of light is delivered during the patient's preparation for sleep and /or the first non-REM stage 1 sleep phase, This preferably takes place at the before or at the beginning of the sleep phase (solid line), at the end of the sleep phase (broken line) or both.
  • the controller actuates the radiation emitter assembly to emit red light at intensity for a period ⁇ e.g.
  • the device delivers the blue light package by controlling the radiation emitter assembly to emit blue light at intensity l 2 for a period ⁇ 2 , which may be equal to, or longer or shorter than AJ ⁇ .
  • red emission is reactivated to deliver the third light package for a duration ⁇ 3 , which in this example corresponds to the full duration of the REM sleep phase (i.e. approx 10 mins).
  • the total light energy delivered at each wavelength, (E ⁇ + E 3 ) and E 2 should be controlled to give the required dosages.
  • the pre-determined timings given in this example are purely exemplary and other intervals could be implemented as desired to synchronise the light irradiation steps with any sleep phases of the patient.
  • FIG. 21 is a flow diagram showing a process performed by the controller when implementing a light irradiation sequence based on feedback from the sleep state sensor 15, in a further embodiment. The process begins at step S601 when a start signal is received from the user, e.g. by turning the device on.
  • the controller then waits for a trigger signal from the sleep state sensor in step S602.
  • a trigger signal from the sleep state sensor in step S602.
  • the controller actuates the light emitter assembly to begin emitting light at the first wavelength ⁇ , e.g. approx. 660 nm (red).
  • the device continues to emit red light until a transition in the sleep state signal is detected at step S304. For example, this may be indicative of the patient transitioning from non- REM stage 1 sleep (predominantly sympathetic) to non-REM stages 2, 3 and 4 sleep (predominantly parasympathetic).
  • step S605 the controller actuates the light emitter assembly to stop emitting red light and to begin emitting light at the second wavelength ⁇ 2 , e.g. approx 420 nm (blue). Blue light emission continues until a second sleep state transition is detected in step S606, e.g. from non-REM stages 2, 3 and 4 sleep to REM sleep.
  • step S607 blue light emission is ceased and red light emission reactivated at ⁇ *, e.g. approx 660 nm.
  • step S608 the detection of a further sleep state transition, e.g. from REM to non-REM phase 1 sleep, triggers the switching off of the device (step S609).
  • Figure 22 shows plots of the sleep state signal S s (here in terms of the amount of sympathetic activity detected), and the light output at each of the two wavelengths.
  • the sleep state signal S s meets criteria considered to be indicative of the patient falling asleep (e.g. a threshold value is crossed).
  • the red LEDs are activated, although there may be a short time lag.
  • the value of S s changes in a manner indicative of a transition between the sleep phases from non- REM state 1 to non-REM states 2, 3 and 4, in response to which the red LEDs are switched off and the blue LEDs on.
  • the sleep state signal S s indicates another sleep phase transition from non-REM stages 2, 3, and 4 to REM, and the blue light package is completed. A final red light package is emitted to complete the first sleep cycle SCi .
  • the duration of each light package ( ⁇ ⁇ 2 etc.) is not pre-determined but rather configured dynamically in response to the real-time behaviour of the patient. Feedback-based irradiation sequences such as this may be appropriate where the intention is to enhance one or more of the patient's sleep cycles, rather than to entrain them towards a certain set of timings.
  • the dosage of each wavelength may be varied according to the patient's needs, possibly to the extent that one or more of the three light packages may be omitted.
  • light irradiation sequences based on a combination of feedback and pre-determined timings. For example, it may be desirable to detect the patient's transitions from one sleep state to the next and use them to trigger the outputting of each light package, although the light packages themselves may be of pre-determined duration.
  • the feedback from the patient could be used to adjust predetermined timings of a light irradiation sequence, either "on the fly" or before the treatment is repeated. For instance, if a light package has a predetermined duration of ⁇ * but the sleep state signal indicates that the patient has not transitioned out of the corresponding sleep phase when ⁇ * has elapsed, a delay time of e.g. 5 minutes may be added to the light package duration to bring it closer to the patient's natural pattern.
  • the light irradiation sequence performed by the device may therefore include one or more "green" light packages timed to coincide with the patient's non-REM stage 2 sleep cycle (described as part of the second sleep phase in the preceding embodiments).
  • the light sequence may be weighted accordingly, following the same principles described above, possibly to the extent that only green light packages are output.
  • the light sequence may consist exclusively of red and green light packages if, for example, it is the transition between the first non-REM stage 1 sleep phase and the subsequent non-REM stage 2 sleep phase that the patient requires assistance with.
  • a sequence made up of only green and blue packages timed to coincide with the patient's non-REM stage 2 and non-REM stages 3/4 sleep phases respectively
  • the green light package is used in conjunction with both red and blue light packages, and an example of such a irradiation sequence will now be described with reference to Figures 23 and 24.
  • Figure 23 is a flow diagram showing the process followed by the controller 14 in this embodiment, where the light irradiation sequence S710 includes four light irradiation steps scheduled according to predetermined timings.
  • the controller waits for a start signal to be received, for example from on/off switch 17.
  • the light irradiation sequence S710 may be initiated immediately by moving directly to step S702.
  • the processes shown in Figures 8a and/or 8b may be implemented to more accurately align the light packages with the patient's sleeping pattern, as described previously.
  • Step S702 is the delivery of the first light package of the light irradiation sequence S710.
  • the controller actuates the irradiation emitter assembly to emit light at a first wavelength for a period ⁇ .
  • this first light irradiation step preferably takes place throughout the patient's first non-REM stage 1 sleep phase and so, in this example, the irradiation parameters are ⁇ 660 nm, ⁇ ⁇ 20 minutes (which includes approximately 10 minutes prior to the patient falling asleep).
  • the process moves to step S703 in which the second light package is delivered.
  • the controller actuates the radiation emitter assembly to emit light at an intermediate wavelength (referred to in places as the "third" wavelength) A 3 for a period ⁇ 2,
  • the second light package corresponds to the patient's first non-REM stage 2 sleep phase and so the radiation parameters may be ⁇ 3 ⁇ 532 nm, ⁇ 2 ⁇ 50 minutes, for example. In other cases, the duration of ⁇ 2 may vary between 40 and 60 minutes, more preferably between 45 and 55 minutes.
  • step S704 the controller actuates the radiation emitter assembly to deliver a third light package at a shorter wavelength A 2 to coincide with the patient's first non- REM stages 3 and 4 sleep phase.
  • the radiation parameters may be ⁇ 2 ⁇ 420 nm, ⁇ 3 ⁇ 23 minutes, for example. In other cases, the duration of ⁇ 3 may vary between 15 and 30 minutes, more preferably between 20 and 25 minutes.
  • the controller then actuates the radiation emitter assembly to deliver a fourth light package in step S705, to coincide with the REM sleep phase which completes the patient's first sleep cycle.
  • the irradiation emitted during this step is of a wavelength ⁇ ⁇ * which as described above should be similar or identical to that emitted during the first irradiation step, i.e. red.
  • the irradiation parameters for this package may be, for example, h ⁇ 660 nm, ⁇ 4 « 10 minutes.
  • Figure 24 illustrates the activation of each wavelength over time for the same example.
  • the upper plot shows the intensity I output at the longest wavelength and A (red light)
  • the middle plot shows the output intensity of the intermediate wavelength A 3 (green)
  • the lower plot shows that of the shortest wavelength A 2 (blue).
  • the various sleep phases are indicated by labels P 2 , P 3 and P 4 , all of which form part of the patient's first sleep cycle (SCi).
  • the controller stops the emission of red light and controls the irradiation emitter assembly to irradiate the patient with green light at intensity l 2 for a period ⁇ 2 , corresponding to the patient's non-REM stage 2 phase.
  • the green light is stopped and the blue light is switched on for a duration ⁇ 3 to support the patient's non-REM stages 3 and 4 phase.
  • the blue light is switched off and the red light switched back on to support the patient's transition from non-REM to REM sleep, for a final duration ⁇ 4 .
  • the amount of energy delivered during each step is illustrated by the areas under the plot EL E 2 , E 3 and E 4 , and preferably this is configured such that (Ei + E 4 ) ⁇ (E 2 ) ⁇ (E 3 ), so that the dosage of each wavelength is approximately equal.
  • the irradiation assembly is switched off.
  • the device preferably emits no light irradiation.
  • any of the presently described light irradiation sequences could be implemented using the device configurations described earlier.
  • suitable energy dosages can also be obtained using a radiation emitter assembly with an LED array comprising four red LEDs, rated at 15mW each at a forward current of 20mA, one green LED having the same rating, and three blue LED rated at 13 mW when operating at the same forward current.
  • the red light dosage (operating at a 50% duty cycle) is approximately 54 J.
  • a forth blue LED and/or a second green LED may be added in some embodiments if higher blue and/or green light dosage is required.

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Abstract

La présente invention concerne un dispositif destiné au traitement d'un patient par rayonnement lumineux. Le dispositif comprend : un ensemble émetteur de rayonnement, pouvant être commandé pour émettre de la lumière sur chacune de première, deuxième et troisième longueurs d'onde, dans cet ordre ; une source d'énergie placée pour apporter de l'énergie à l'ensemble émetteur de rayonnement ; et un dispositif de commande conçu pour actionner l'ensemble émetteur de rayonnement pour produire une séquence de rayonnement lumineux de trois modules de lumière séquentiels ou plus. Le ou chaque module de lumière est produit par l'émission de lumière sur l'une des première, deuxième et troisième longueurs d'onde pendant une certaine période. La séquence de rayonnement lumineux comprend au moins un module de lumière de la première longueur d'onde, au moins un module de lumière de la deuxième longueur d'onde et au moins un module de lumière de la troisième longueur d'onde. La séquence de rayonnement lumineux comprend au moins une période de retard entre les modules de lumière, au cours de laquelle aucun rayonnement n'est émis. L'invention concerne également un programme destiné à commander un ensemble émetteur de rayonnement et un procédé de traitement d'un patient par rayonnement lumineux.
PCT/GB2012/052852 2011-11-16 2012-11-16 Dispositif, programme et procédé de traitement par rayonnement lumineux Ceased WO2013072701A1 (fr)

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GB1119778.7 2011-11-16
GB1119778.7A GB2496628A (en) 2011-11-16 2011-11-16 Phototherapy device emitting light of three different colours

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WO2016209834A1 (fr) * 2015-06-22 2016-12-29 Quantum Dynamics L.L.C. Dispositif permettant de fournir une régulation de la température corporelle et/ou une lumière thérapeutique dirigée vers le système vasculaire
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US10780295B2 (en) 2010-02-05 2020-09-22 Wisconsin Alumni Research Foundation Method for treating multiple sclerosis
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WO2024239807A1 (fr) * 2023-05-19 2024-11-28 青岛海尔智能技术研发有限公司 Procédé et appareil d'amélioration du sommeil, et support de stockage

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WO2017193318A1 (fr) * 2016-05-12 2017-11-16 深圳市赛亿科技开发有限公司 Système d'aide au sommeil
EP3727582A4 (fr) * 2017-11-17 2021-08-25 Project LEAH, LLC Dispositif d'éclairage de la chair
WO2024164045A1 (fr) * 2023-02-06 2024-08-15 Gbl Ip Pty Ltd Dispositif électroluminescent conçu pour être porté pendant le sommeil

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US10780295B2 (en) 2010-02-05 2020-09-22 Wisconsin Alumni Research Foundation Method for treating multiple sclerosis
US11260241B2 (en) 2010-02-05 2022-03-01 Wisconsin Alumni Research Foundation Method of treating multiple sclerosis
CN106455596A (zh) * 2014-03-31 2017-02-22 飞利浦灯具控股公司 水果和/或蔬菜的新鲜度
EP3125697B1 (fr) * 2014-03-31 2020-08-12 Signify Holding B.V. Fraîcheur de fruits et/ou de légumes
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US12408678B2 (en) 2014-03-31 2025-09-09 Signify Holding B.V. Freshness of fruit and/or vegetables
WO2016007798A3 (fr) * 2014-07-09 2016-03-17 Akari Systems, Inc. Source lumineuse thérapeutique portable
WO2016209834A1 (fr) * 2015-06-22 2016-12-29 Quantum Dynamics L.L.C. Dispositif permettant de fournir une régulation de la température corporelle et/ou une lumière thérapeutique dirigée vers le système vasculaire
US10183174B2 (en) 2015-06-22 2019-01-22 Quantum Dynamics, LLC Device for providing body temperature regulation and/or therapeutic light directed to vasculature
EP4262973A4 (fr) * 2020-12-15 2024-10-16 Advanced Light Devices, LLC Procédé et système de luminothérapie pour la désagrégation des globules rouges et le traitement de maladies respiratoires
WO2024239807A1 (fr) * 2023-05-19 2024-11-28 青岛海尔智能技术研发有限公司 Procédé et appareil d'amélioration du sommeil, et support de stockage

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