NCT06874855

Lemborexant in Delayed Sleep Phase Syndrome

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Delayed sleep phase syndrome (DSPS) is a disorder in which a person's sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime. The delayed sleep then causes difficulty in being able to wake up at the desired time. In DSPS, bedtime is shifted later than the general population such that individuals have difficulty getting enough sleep to meet their sleep need before they have to get up for their daytime obligations (work, school, childcare, etc.). As a result, patients experience daytime impairment including daytime sleepiness and cognitive impairment. DSPS, if maintained in adulthood is associated with numerous deleterious health effects, although causality is not well established. The prevalence of this condition is approximately 7-16% among adolescents and young adults.

Conditions

• Delayed Sleep Phase Syndrome

Interventions

Type	Name	Description
DRUG	Lemborexant	Lemborexant tablet administered orally once daily
DRUG	Placebo	Placebo to match Lemborexant tablet administered orally once daily

Timeline

• Start date: 2023-03-13
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2025-03-13
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study