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Idiopathic hypersomnia (IH) is a chronic disabling disorder characterized by excessive daytime sleepiness (EDS), prolonged nighttime sleep and sleep inertia. IH is a rare disorder, estimated around 0.05%, yet its true prevalence remains unknown. Disease onset occurs most often during young adulthood and is accompanied by severe social, professional and economic impairments, resulting in risk of accident and a loss in patient's quality of life. There are no ANSM (or FDA-) approved treatments for IH symptoms.
IH shares common features with delayed sleep-wake phase disorder (DSWPD) which is a chronic circadian rhythm disorder which occurs as in IH during young adulthood. The combination of evening melatonin and morning bright light therapy is the most effective validated chronotherapy in DSWPD.Moreover, bright light therapy has direct effects and is known to increase daytime alertness and to improve mood.
Melatonin is empirically used in routine clinical practice in patients with IH and French and European recommendations mention melatonin as a possible treatment of sleep inertia in IH.
. Our goal is to bring a proof of concept of a safe therapeutic practice for IH combining exogenous melatonin and bright light therapy in
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active therapy | Experimental | Active therapy combining evening melatonin + morning active light over 6 weeks |
|
| Placebo therapy | Placebo Comparator | placebo therapy combining evening melatonin placebo + morning placebo light over 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| - Melatonin - Active light ttherapy | Combination Product | 1 tablet per day, in the evening + morning light therapy over 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Idiopathic Hypersomnia Severity Severity Scale (IHSS) | The Idiopathic Hypersomnia Severity Severity Scale is a self-administered questionnaire that was designed specifically to quantify HI symptoms the minimum value is 0 and the maximum values 50 means a worse outcome. | At Day 14 and day 45 |
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Inclusion criteria:
Exclusion criteria:
Criteria related to the underlying disorder (other forms of hypersomnia or sleep disorder)
Criteria related to pathologies associated with particular risks or consumption of substances that may affect sleep or alertness:
Criteria related to circadian rhythms disturbances
criteria related to medications (within 1 month prior to study)
Criteria related to relative contra-indications to light therapy
Criteria relative to exogenous melatonin administration
Criteria relative to relative contraindications of e-celsius capsules
Criteria relative to regulation:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrice BOURGIN, MD | Contact | 03 88 11 64 30 | 0033 | pbourgin@unistra.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
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| - Placebo drug - Placebo light therapy | Combination Product | 1 tablet per day in the evening + morning placebo light therapy |
|
| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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