Idiopathic HypersomniaPhase 2HyperChronoNCT06252571
a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
A Phase 2 study testing - Melatonin - Active light ttherapy in people with Idiopathic Hypersomnia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Idiopathic Hypersomnia
- What is being tested?
- - Melatonin - Active light ttherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2024to 7 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
- 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…)
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- 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)
- 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, …)
- 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)
- 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
- 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…
- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Patrice BOURGIN, MD, 03 88 11 64 30 ext. 0033, pbourgin@unistra.fr
About this study
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.
Read more
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
- Idiopathic Hypersomnia
- Being tested
- - Melatonin - Active light ttherapy, - Placebo drug - Placebo light therapy
- Keywords
- hypersomnia, light, melatonin, sleep, chronobiotherapy
- Medical subject headings
- Idiopathic Hypersomnia, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Melatonin - Active light ttherapyCombination product
1 tablet per day, in the evening + morning light therapy over 6 weeks
- Placebo drug - Placebo light therapyCombination product
1 tablet per day in the evening + morning placebo light therapy
| Study group | Role | What they receive |
|---|---|---|
| Active therapy | Experimental | Active therapy combining evening melatonin + morning active light over 6 weeks Receives: Combination Product: - Melatonin - Active light ttherapy |
| Placebo therapy | Placebo comparator | placebo therapy combining evening melatonin placebo + morning placebo light over 6 weeks. Receives: Combination Product: - Placebo drug - Placebo light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Idiopathic Hypersomnia Severity Severity Scale (IHSS)
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.
Measured: At Day 14 and day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start7 Sep 2024
- Primary completion7 Sep 2027 (estimated)
- Study completion7 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic HypersomniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252571
- Sponsor's protocol ID
- 8443
- Acronym
- HyperChrono
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
- ClinicalTrials.gov ID
- NCT06252571
- Acronym / sponsor ID
- HyperChrono / 8443
- Conditions
- Idiopathic Hypersomnia
- Keywords
- hypersomnia, light, melatonin, sleep, chronobiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 7 Sep 2027 (estimated)
- Study completion
- 7 Sep 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active therapy | Experimental | Combination Product: - Melatonin - Active light ttherapyActive therapy combining evening melatonin + morning active light over 6 weeks |
| Placebo therapy | Placebo comparator | Combination Product: - Placebo drug - Placebo light therapyplacebo therapy combining evening melatonin placebo + morning placebo light over 6 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (42 listed)
- Criteria related to the underlying disorder (other forms of hypersomnia or sleep disorder)
- Criteria related to pathologies associated with particular risks or consumption of substances that may affect sleep or alertness:
- Criteria related to circadian rhythms disturbances
- criteria related to medications (within 1 month prior to study)
- Criteria related to relative contra-indications to light therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| - Melatonin - Active light ttherapy1 tablet per day, in the evening + morning light therapy over 6 weeks | Combination product | Active therapy |
| - Placebo drug - Placebo light therapy1 tablet per day in the evening + morning placebo light therapy | Combination product | Placebo therapy |
Primary outcome
Idiopathic Hypersomnia Severity Severity Scale (IHSS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing - Melatonin - Active light ttherapy in people with Idiopathic Hypersomnia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrice BOURGIN, MD (03 88 11 64 30 ext. 0033, pbourgin@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Idiopathic Hypersomnia Severity Severity Scale (IHSS) (time frame: At Day 14 and day 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.