Lemborexant in Delayed Sleep Phase Syndrome

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06874855
Phase
PHASE4
Status
Recruiting
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Conditions

  • Delayed Sleep Phase Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lemborexant — DRUG
    Lemborexant tablet administered orally once daily
  • Placebo — DRUG
    Placebo to match Lemborexant tablet administered orally once daily

Study Details

The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients with delayed sleep phase syndrome (both type 1 and type 2). This will be tracked using sleep logs as well as actigraphy. In this 2-year study, the investigators will examine if Lemborexant administered 5-10 mg nightly taken at desired bedtime (at least 2 hours prior to self-reported sleep onset habitual time) can improve the symptoms of Delayed Sleep Phase Syndrome.

Key Dates

Start date
Mar 13, 2023
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Patients receive placebo to match Lemborexant for 14 days
  • Active Comparator: Lemborexant
    Patients receive Lemborexant 5mg for 7 days and may be dose adjusted to 10mg. Patients continue to take Lemborexant 5mg or 10mg for an additional 7 days

Primary Outcome Measure

Change in actigraphy sleep latency onset [ Time Frame: From 2 weeks prior to randomization to 4 weeks post randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94107
Andrew D Krystal, MD MS
[email protected]
415-476-7702

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By research site
University of California San Francisco· San Francisco, CA

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