Can melatonin and morning light reset the body clock to fight excessive sleepiness?
NCT ID NCT06252571
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial tests whether combining evening melatonin with morning bright light therapy can reduce excessive daytime sleepiness and sleep inertia in adults with idiopathic hypersomnia, a rare disorder causing prolonged sleep and difficulty waking. Participants aged 18 to 40 will receive either the active combination or a placebo for six weeks. The study aims to see if this chronobiological approach, already used for circadian rhythm disorders, could become a safe treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of evening melatonin tablets and morning bright light therapy
- What this could lead to
- If effective, this combination could offer a safe, non-drug treatment to reduce daytime sleepiness and improve daily functioning in people with idiopathic hypersomnia.
- What could go wrong
- This is a small, early-stage trial, and the benefits may not be confirmed. Melatonin can cause drowsiness, and light therapy may cause eye strain or headaches.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Male or female patient * Age ≥ 18 and ≤ 40 years at signature of informed consent form * Diagnosed with Idiopathic hypersomnia in a reference/competence center of hypersomnia rare disease network according to ICSD-3 criteria (International classification of sleep disorders) with symptoms lasting since \>3 months and a total sleep time ≥11hours objectified with a 24h continuous polysomnography realized during the last 12 months * Patient with stable medication in the month preceding inclusion and throughout the 10 weeks of participation to the study (except for drugs excluding participation. See list below). * Patient able to be compliant with therapy during the required time and at the set schedule. * For female patient: effective efficient contraception during the month preceding the inclusion and all along the study * Patient who have given written informed consent and are able to understand the objectives and risks associated to the research. * Patient affiliated to a social security insurance Exclusion criteria: 1. Criteria related to the underlying disorder (other forms of hypersomnia or sleep disorder) * Other primary or secondary hypersomnia (narcolepsy, Kleine-Levin syndrome, post-traumatic hypersomnia, hypersomnia due to medication or substance abuse…) * Other intrinsic sleep disorder according to ICSD-3 criteria (sleep apnea syndrome, restless legs syndrome, insomnia) 2. Criteria related to pathologies associated with particular risks or consumption of substances that may affect sleep or alertness: * Significant psychiatric comorbidities (current severe depressive episode based on the DSM-V criteria, risk of suicide, schizophrenia, bipolar disorder). * Known systemic or severe acute disease (auto-immune diseases…) * Substance / alcohol /cigarette dependence * Consumption of excessive amounts of caffeine, defined as greater than 600 mg of caffeine of coffee, tea, cola, energy drinks, or other caffeinated beverages per day (1 cup of coffee is approximately 120 mg) 3. Criteria related to circadian rhythms disturbances * Recent transmeridian travel (\> 2 time zones) within the month before the start of the study * History of shift/night work reported within the 6 months preceding the study * Irregular sleep habits (more than 2 hours of delay or advance in bedtime ≥ 3 nights over a week) * Circadian sleep-wake rhythm disorders according to ICSD-3 criteria (advanced or delayed sleep phase syndrome, …) 4. criteria related to medications (within 1 month prior to study) * Sleep promoting drugs (benzodiazepines, z-drugs, sodium oxybate, antihistaminics…) * Wake promoting-drugs (modafinil, pitolisant, methylphenidate, solriamfétol chlorhydrate) * Psychotropics and drugs inducing level 3 sleepiness according to the ANSM (French National Agency for Medicines and Health Products Safety) gradation. * beta-blockers * regular anti-inflammatory drug intake * Exogenous melatonin and/or serotonin and or tryptohane (as a drug or a dietary supplement) 5. Criteria related to relative contra-indications to light therapy * Medical history of ophthalmologic diseases causing visual impairment: retinopathy, age-related macular degeneration, macular hole, epiretinal membrane; cataract; optic neuropathy. * On-going medication with a photosensibilizing drug * Photosensitive epilepsia or migraine 6. Criteria relative to exogenous melatonin administration * Prior intolerance to cellulose or exogenous melatonin * Drugs metabolized by CYP1A2 intake within 1 month prior to study: antivitamin K, fluvoxamine, cimetidine, carbamazepine, rifampicin… 7. Criteria relative to relative contraindications of e-celsius capsules * Patient weighting less than 40 kg * Medical history of motility disorders of the gastrointestinal tract and intestinal disorders that can lead to obstruction of the digestive tract, including diverticula, Crohn disease, surgical procedures in the gastrointestinal tract * Known swallowing disorders * In presence of a pacemaker or electro-medical implant. * Patient who has to undergo strong electromagnetic field during the period of use of the system (MRI) 8. Criteria relative to regulation: * Pregnancy, breastfeeding. * Participation in another interventional clinical trial with an exclusion period * Patient with difficulty to read or understand French, or inability to understand the delivered information * Patient in emergency situation * Patient in life-threatening situation * Patient under justice safeguard * Patient under guardianship or limited guardianship * Patient unwilling to refrain from driving and/or operating dangerous or hazardous machinery during times of heightened sleepiness or fatigue due to the medication
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, 67000, France
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