a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idio
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
| Condition(s) | Idiopathic Hypersomnia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 DSWP |
| Who can participate | Inclusion criteria: * Male or female patient * Age ≥ 18 and ≤ 40 years at signature of informed consent form * Diagnosed with Idiopathic hypersomnia in a reference/competence center of hypersomnia rare disease network according to ICSD-3 criteria (International classification of sleep disorders) with symptoms lasting since \>3 months and a total sleep time ≥11hours objectified with a 24h continuous polysomnography realized during the last 12 months * Patient with stable medication in the month preceding inclusion and throughout the 10 weeks of participation to the study (except for drugs excluding participation. See list below). * Patient able to be compliant with therapy during the required time and at the set schedule. * For female patient: effective efficient contraception during the mo |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Lead sponsor | University Hospital, Strasbourg, France |
| Locations | Strasbourg, France |
| Start date | 2024-09-07 |
| NCT ID | NCT06252571 |
| Official listing | https://clinicaltrials.gov/study/NCT06252571 |