RecruitingPhase 4NCT06874855

Lemborexant in Delayed Sleep Phase Syndrome


Sponsor

University of California, San Francisco

Enrollment

15 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This 2-year study is testing whether Lemborexant, a medication that works by blocking the brain's wake-promoting signals, can help people with delayed sleep phase syndrome (DSPS) fall asleep earlier at their desired bedtime. DSPS is a circadian rhythm disorder where people naturally fall asleep 2 or more hours later than they wish, causing daytime fatigue and difficulty waking on time. You may be eligible if you are 18 or older, have been diagnosed with DSPS based on established criteria, do not have significant depression, anxiety, or other sleep disorders, and are not a shift worker or taking medications that strongly affect sleep. Participation involves taking a 5 to 10 mg tablet nightly, tracking your sleep with a diary and wrist monitor (actigraphy), and attending follow-up visits over 2 years. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLemborexant

Lemborexant tablet administered orally once daily

DRUGPlacebo

Placebo to match Lemborexant tablet administered orally once daily


Locations(1)

University of California San Francisco

San Francisco, California, United States

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NCT06874855


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