Light Therapy for Chronic Insomnia in General Practice

Study Overview
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Brief Summary
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Sleep disorders, especially insomnia Attention deficits (or disorders), daytime somnolence and drug dependence The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice

Detailed Description
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Insomnia affects 15 to 20% of the general French adult population and increases with age. General practitioners (GPs) are the first confronted to sleep disorders, especially insomnia. Cognitive-behavioral therapies (CBT) have proven effective, but their implementation in everyday practice is limited, and alternative treatments are still needed. Light not only has a great influence on the sleep-wake cycle and alertness, but also on mood and cognitive functions. The administration time of light condition will be calculated for each individual in a modality that has no impact on the circadian phase. Study will be conduct on an outpatient basis in general practice

Official Title
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Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study

Conditions
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Insomnia Chronic, Sleep Disorder, Circadian Rhythm Disorders

Intervention / Treatment
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* Device: Active luminette
* Device: Placebo luminette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complaining of chronic insomnia according to ICSD-3 (International Classification of Sleep Disorders) criteria and/or taking hypnotics at least 3 nights per week for more than 3 months. Non-hypnotic medication: stable medication during one month preceding the inclusion and for the 8 weeks of the study. Compliance with the treatment: the patient is able to have light therapy during the required time and at the agreed schedule. Exclusion Criteria: Severe psychiatric disorder (severe major depression, schizophrenia, bipolar disorder), obvious acute psychiatric comorbidity. Untreated intrinsic sleep pathology: sleep apnea syndrome based on clinical criteria: STOP-BANG questionnaire score, restless legs syndrome manifesting more than 2 times a week and/or requiring treatment. Mild to severe dementia. Neurodegenerative sleep troubles Severe intercurrent pathology. Ophthalmic troubles presenting a contraindication to light therapy: retinopathy, age-related macular degeneration, diabetic retinopathy, macular hole, epiretinal membrane); lens opacifications (cataract) justifying surgery (correction of poor visual acuity, visual discomfort); glaucomatous and non-glaucomatous optic neuropathy resulting in visual impairement. Toxicomania, chronic alcoholism. Secondary insomnia linked to somatic non-stabilized pathology. Elements influencing circadian rhythm Pregnancy, breastfeeding. Participation in another interventional clinical trial which includes an exclusion period No information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.) Patient under guardianship Non hypnotic treatment potentially inducing a level 3 sleepiness one week before

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active light<br>active blue-enriched bright light | Device: Active luminette<br>* receive an active blue-enriched light-glasses of 1500 lux (an average of 180 photons/s/cm2, with a maximum wavelenght at 468 nm), 30-minute long light therapy in the morning, in a time period defined by sleep log and chronotype questionnaire, on a 4-week period<br>|
| Placebo Comparator: Placebo light<br>dim red placebo light | Device: Placebo luminette<br>* receive a dim red-light placebo light (an average of n photons/s/cm2, single- band spectrum with a narrow peak at 660 nm under 50 lux), with the same modality as the experimental group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of sleep efficiency between active and placebo light condition | ratio of total sleep time on total time in bed in measured with actimetry | Before light therapy | 
| Difference of sleep efficiency between active and placebo light condition | ratio of total sleep time on total time in bed measured with actimetry | After 4 weeks of light therapy |