Actively Recruiting
Lemborexant in Delayed Sleep Phase Syndrome
Led by University of California, San Francisco · Updated on 2025-04-24
15
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
E
Eisai Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lemborexant in Delayed Sleep Phase Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older
- Diagnosed with delayed sleep phase syndrome (DSPS) based on ICSD3 criteria
- Sleep is delayed by two hours or more beyond acceptable bedtime
- Difficulty falling asleep before the delayed bedtime
- Sleep delay interferes with social or personal activities
- Willing and able to comply with all study requirements
- Concomitant medications allowed if doses remain stable throughout the study
You will not qualify if you...
- Clinically significant depression (PHQ-9 score 10 or higher), anxiety disorder (GAD-7 score 10 or higher), substance use disorder, or other sleep or medical disorders that could affect the trial
- Use of medications affecting sleep-wake function unless stopped at least 5 half-lives prior to participation
- Use of CYP3A inhibitors or inducers within 1 week before baseline phase
- Pregnancy, planned pregnancy within 3 months, or breastfeeding
- Shift workers or those with unusual work hours
- Transmeridian travel across more than 3 time zones within 4 weeks before screening
- Transmeridian travel across more than 2 time zones during the trial
- Positive drug test or unwillingness to avoid illegal drugs or marijuana during the trial
- Clinically abnormal symptoms or organ impairment requiring medical treatment at screening
- Impaired liver function with AST or ALT levels above 1.5 times upper limit
- Known HIV positive status
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California San Francisco
San Francisco, California, United States, 94107
Actively Recruiting
Research Team
A
Andrew D Krystal, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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