Actively Recruiting
A Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double-Blind, Randomized, Placebo-Controlled Trial
Led by University Hospital, Strasbourg, France · Updated on 2025-08-08
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Idiopathic hypersomnia (IH) is a rare, chronic disorder marked by excessive daytime sleepiness, long nighttime sleep, and difficulty waking up. It often begins in young adulthood and causes serious social, professional, and economic challenges, leading to accidents and reduced quality of life. There are currently no approved treatments for IH symptoms. This study aims to test a safe treatment combining evening melatonin and morning bright light therapy, which has been effective in related sleep disorders and may improve alertness and mood in IH patients. Participants will receive either an active therapy of one melatonin tablet each evening plus morning bright light therapy, or a placebo consisting of a placebo tablet and placebo light therapy, both over a period of 6 weeks. This randomized, triple-blind trial compares these two groups to evaluate the effects of this combined chronobiological treatment. The study is conducted by the University Hospital in Strasbourg, France. During the study, participants will be monitored and assessed for changes in their IH symptoms using the Idiopathic Hypersomnia Severity Scale at days 14 and 45. The study includes careful screening, adherence to treatment schedules, and safety checks. Participants will be followed throughout the 10 weeks of the study to evaluate treatment impact and tolerability, with all procedures designed to understand if this therapy improves daytime alertness and quality of life.
CONDITIONS
Brief Title
a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient
- Age 18 to 40 years at signing informed consent
- Diagnosed with idiopathic hypersomnia according to ICSD-3 criteria, with symptoms lasting over 3 months
- Total sleep time of at least 11 hours confirmed by 24-hour continuous polysomnography within the last 12 months
- Stable medication for at least one month before inclusion and throughout the 10-week study period (except excluded drugs)
- Able to comply with therapy schedule during the study
- For females, effective contraception required one month before and during the study
- Provided written informed consent and can understand study objectives and risks
- Affiliated with social security insurance
You will not qualify if you...
- Other forms of hypersomnia or sleep disorders (e.g., narcolepsy, Kleine-Levin syndrome, sleep apnea, restless legs syndrome, insomnia)
- Significant psychiatric conditions (severe depression, suicide risk, schizophrenia, bipolar disorder)
- Known systemic or severe acute diseases such as autoimmune disorders
- Substance, alcohol, or cigarette dependence
- Excessive caffeine intake above 600 mg per day
- Recent travel across more than 2 time zones within one month before study
- Shift or night work within 6 months before study
- Irregular sleep habits with frequent shifts over 2 hours
- Circadian rhythm sleep-wake disorders
- Recent use of sleep-promoting or wake-promoting drugs, psychotropics inducing sleepiness, beta-blockers, anti-inflammatory drugs, or exogenous melatonin/serotonin/tryptophan supplements within one month
- Medical history of eye diseases causing visual impairment or photosensitive epilepsy/migraine
- Use of photosensitizing medications
- Prior intolerance to cellulose or melatonin
- Use of certain drugs metabolized by CYP1A2 within one month
- Weighing less than 40 kg
- History of gastrointestinal motility or swallowing disorders
- Presence of pacemaker or electro-medical implant
- Pregnancy or breastfeeding
- Participation in other interventional clinical trials
- Difficulty understanding French or study information
- Emergency or life-threatening conditions
- Under legal guardianship or protection
- Unwillingness to refrain from driving or operating hazardous machinery during increased sleepiness or fatigue due to study medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take 1 tablet in the evening and undergo morning light therapy or placebo for 6 weeks.
Visits at Day 14 and Day 45 for assessments
Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
P
Patrice BOURGIN, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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