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

Phase 2

Not yet recruiting

• Conditions: Idiopathic Hypersomnia
• Interventions: Combination Product: - Melatonin - Active light ttherapy; Combination Product: - Placebo drug - Placebo light therapy

• 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
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Study Start: 2024-09-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active therapy	- Melatonin - Active light ttherapy	Active therapy combining evening melatonin + morning active light over 6 weeks
Placebo therapy	- Placebo drug - Placebo light therapy	placebo therapy combining evening melatonin placebo + morning placebo light over 6 weeks.

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