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

Phase 2

Recruiting

• Conditions: Idiopathic Hypersomnia

• Registration Number: NCT06252571
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Study Start: 2024-09-07
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-08
• Primary Completion: 2027-09-07
• Study Completion: 2027-09-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Idiopathic Hypersomnia Severity Severity Scale (IHSS)	At Day 14 and day 45	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.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France