Actively Recruiting
a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
Led by University Hospital, Strasbourg, France · Updated on 2025-08-08
72
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 informed consent
- Diagnosed with idiopathic hypersomnia according to ICSD-3 with symptoms lasting over 3 months
- Total sleep time of 11 hours or more confirmed by 24h polysomnography within last 12 months
- Stable medication for at least one month before inclusion and during study
- Able to comply with therapy and schedule
- For females, effective contraception during the month before and throughout the study
- Provided written informed consent and understand study objectives and risks
- Affiliated with social security insurance
You will not qualify if you...
- Other primary or secondary hypersomnia or sleep disorders (narcolepsy, Kleine-Levin syndrome, sleep apnea, restless legs, insomnia)
- Severe psychiatric disorders (severe depression, suicide risk, schizophrenia, bipolar)
- Severe systemic or acute diseases
- Substance, alcohol, or cigarette dependence
- Consuming more than 600 mg caffeine daily
- Recent transmeridian travel over 2 time zones in past month
- Shift or night work in past 6 months
- Irregular sleep habits with more than 2 hours variation on 3 or more nights per week
- Circadian rhythm sleep-wake disorders
- Use of sleep-promoting or wake-promoting drugs within 1 month prior
- Psychotropic drugs causing severe sleepiness
- Beta-blockers or regular anti-inflammatory drugs
- Use of exogenous melatonin, serotonin, or tryptophan
- Eye diseases affecting vision or photosensitivity
- Use of photosensitizing medication
- Photosensitive epilepsy or migraine
- Intolerance to melatonin or cellulose
- Use of certain CYP1A2 metabolized drugs
- Weight under 40 kg
- Gastrointestinal motility or swallowing disorders
- Presence of pacemaker or electro-medical implant
- MRI planned during study
- Pregnancy or breastfeeding
- Participation in another interventional trial
- Difficulty understanding French or study information
- Emergency or life-threatening conditions
- Under legal guardianship or unable to consent
- Unwilling to refrain from driving or hazardous activities during sleepiness
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
P
Patrice BOURGIN, MD
CONTACT
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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