Insolux: Light Therapy for Chronic Insomnia in General Practice
Study Details
Study Description
Brief Summary
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Sleep disorders, especially insomnia
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Attention deficits (or disorders), daytime somnolence and drug dependence
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The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active light active blue-enriched bright light |
Device: Active luminette
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
|
| Placebo Comparator: Placebo light dim red placebo light |
Device: Placebo luminette
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
|
Outcome Measures
Primary Outcome Measures
- Difference of sleep efficiency between active and placebo light condition [Before light therapy]
ratio of total sleep time on total time in bed in measured with actimetry
- Difference of sleep efficiency between active and placebo light condition [After 4 weeks of light therapy]
ratio of total sleep time on total time in bed measured with actimetry
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Non-hypnotic medication: stable medication during one month preceding the inclusion and for the 8 weeks of the study.
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Compliance with the treatment: the patient is able to have light therapy during the required time and at the agreed schedule.
Exclusion Criteria:
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Severe psychiatric disorder (severe major depression, schizophrenia, bipolar disorder), obvious acute psychiatric comorbidity.
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Untreated intrinsic sleep pathology: sleep apnea syndrome based on clinical criteria: Berlin questionnaire score, restless legs syndrome manifesting more than 2 times a week and/or requiring treatment.
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Mild to severe dementia.
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Neurodegenerative sleep troubles
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Severe intercurrent pathology.
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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.
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Toxicomania, chronic alcoholism.
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Secondary insomnia linked to somatic non-stabilized pathology.
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Elements influencing circadian rhythm
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Pregnancy, breastfeeding.
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Participation in another interventional clinical trial which includes an exclusion period
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No information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.)
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Patient under guardianship
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Non hypnotic treatment potentially inducing a level 3 sleepiness one week before
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nantes | Nantes | France | 44210 | |
| 2 | CHU Reims | Reims | France | 51092 | |
| 3 | Hôpitaux Universitaires de Strasbourg | Strasbourg | France | 67091 |
Sponsors and Collaborators
- University Hospital, Strasbourg, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 7348