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

NCT06252571 | Recruiting Phase 2

• 1 other identifier: 8443
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Idiopathic Hypersomnia

Keywords

hypersomnia; light; melatonin; sleep; chronobiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  At Day 14 and day 45

Study Arms (2)

Active therapy

EXPERIMENTAL

Active therapy combining evening melatonin + morning active light over 6 weeks

Combination Product: - Melatonin - Active light ttherapy

Placebo therapy

PLACEBO COMPARATOR

placebo therapy combining evening melatonin placebo + morning placebo light over 6 weeks.

Combination Product: - Placebo drug - Placebo light therapy

Interventions

- Melatonin - Active light ttherapy COMBINATION_PRODUCT

1 tablet per day, in the evening + morning light therapy over 6 weeks

Active therapy

- Placebo drug - Placebo light therapy COMBINATION_PRODUCT

1 tablet per day in the evening + morning placebo light therapy

Placebo therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 able to be compliant with therapy during the required time and at the set schedule.
• 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

You may not qualify if:

• 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…)
• 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…)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Idiopathic Hypersomnia; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Patrice BOURGIN, MD

CONTACT

03 88 11 64 30; pbourgin@unistra.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: September 7, 2024
• Primary Completion (Estimated): September 7, 2027
• Study Completion (Estimated): September 7, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)