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Sleep disorders represent a major public health issue and the leader in these disorders is insomnia with 10 to 15% of subjects in the general population reporting symptoms of insomnia with a daytime impact. In addition to being very common, insomnia leads to an increase in morbidity and mortality and weighs on healthcare systems worldwide. Despite this public health context, insomnia is underdiagnosed and rarely treated. Hypnotics have proven efficacy but with a risk of dependence and pharmacotolerance which appears within a few weeks. Cognitive behavioral therapy (CBT) has a good level of evidence and is now a benchmark treatment for the management of insomnia. Unfortunately, not all patients adhere to or respond to these procedures, which cannot be implemented for many of them either. There is therefore a need to identify other alternative therapeutic strategies, and we believe that exposure to light is a promising treatment.
In this perspective, it seems interesting to assess the effect of the propensity to fall asleep with an exposure to light therapy in patients suffering from insomnia.
In order to be in optimal ecological conditions, we want to use a portable light therapy device which allows easy, acceptable and ambulatory exposure.
If the lighttherapy is confirmed in insomnia under ecological conditions, this would make it possible to propose a new non-drug treatment, easy to access and on a large scale
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator |
| |
| Light therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo with light therapy glasses | Other | Placebo |
| |
| light therapy with light therapy glasses |
| Measure | Description | Time Frame |
|---|---|---|
| Change Sleep latency | Actimetry is used to compare the sleep latency | At day 0 and Day 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Change Daytime sleepiness | Epworth Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention | At day 0 and Day 90 |
| Change Daytime sleepiness |
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Inclusion Criteria:
Exclusion Criteria:
- Shift work in the year preceding inclusion
Trans meridian travel (> 2 time zones) in the month preceding inclusion
Patient in exclusion period determined by a previous or ongoing study
Impossibility of giving the patient informed information (emergency patient, difficulty understanding the patient)
Patient under judicial protection
Patient under guardianship or curatorship
For a woman of childbearing age: ongoing pregnancy or breastfeeding
Drug treatment which can disturb sleep or the measurement of DLMO: corticosteroids by general route, beta-blockers in the evening, exogenous melatonin.
Phase delay syndrome defined according to the criteria of the international classification of ICSD-3
Restless legs syndrome with IRLS score> 20
Other psychiatric disorders or addictive disorder (screening with the MINI structured interview)
Other medical conditions not stabilized (detected by clinical interview), only the diseases appearing in the following list will constitute a criterion of non-inclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrice BOURGIN, MD | Contact | 03 88 11 64 30 | 0033 | pbourgin@unistra.fr |
| Name | Affiliation | Role |
|---|---|---|
| Patrice BOURGIN, MD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Other |
light therapy |
|
Karolinska Sleepiness Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention
| At day 0 and Day 90 |
| Change Circadian rythms | Circadian markers melatonin is measured in baseline, completion of the procedure and three month after intervention | At day 0 and Day 90 |
| D001523 |
| Mental Disorders |