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RECRUITING
NCT06252571
PHASE2

a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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 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

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-09-07

Completion Date

2027-09-07

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

- Melatonin - Active light ttherapy

1 tablet per day, in the evening + morning light therapy over 6 weeks

COMBINATION_PRODUCT

- Placebo drug - Placebo light therapy

1 tablet per day in the evening + morning placebo light therapy

Locations (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France