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

Study acronym: HyperChrono
StatusRecruiting
PhasePhase 2
Started2024-09-07
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
minor
Study Status, Oversight, IPDSharing v4
Re-verified, no change to tracked fields
2025-08-04
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations, IPDSharing v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-03-01→2027-09-07
Completion date2027-04-01→2027-09-07
Start dateestimated 2024-09-01→confirmed 2024-09-07
Study sitesdetails revised at 1 of 1 site
2024-08-28
minor
Study Status v2
Start date2024-03-01→2024-09-01
2024-02-09
minor
Study Status, Outcome Measures v1
Primary endpoints1 entry, revised
The Idiopathic Hypersomnia Severity Severity Scale (IHSS)
2024-02-01
minor
Original filing
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
Trial Details
NCT Number NCT06252571
Lead Sponsor University Hospital, Strasbourg, France
Conditions Idiopathic Hypersomnia
Enrollment 72 participants
Start Date 2024-09-07
Primary Completion 2027-09-07 (estimated)
Study Completion 2027-09-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-20