Lemborexant for Delayed Sleep Phase Syndrome

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Stanford Univeristy, Redwood City, CA
Delayed Sleep Phase Syndrome+2 More
Lemborexant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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, we 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.

Eligible Conditions

  • Delayed Sleep Phase Syndrome

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Delayed Sleep Phase Syndrome

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: From 2 weeks prior to randomization to 4 weeks post randomization

Week 4
Change in actigraphy derived total sleep time
Change in actigraphy sleep latency onset
Change in mean actigraphy derived wake time
Change in mean sleep diary derived wake time
Change in sleep diary derived sleep onset latency
Change in sleep diary derived total sleep time.
Sleep Regularity Index
Week 4
Change in Epworth Sleepiness Scale (ESS)
Change in Karolinska Sleepiness Scale (KSS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Delayed Sleep Phase Syndrome

Trial Design

2 Treatment Groups

Lemborexant
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Lemborexant · Has Placebo Group · Phase 4

Lemborexant
Drug
ActiveComparator Group · 1 Intervention: Lemborexant · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from 2 weeks prior to randomization to 4 weeks post randomization
Closest Location: Stanford Univeristy · Redwood City, CA
Photo of california 1Photo of california 2Photo of california 3
2015First Recorded Clinical Trial
1 TrialsResearching Delayed Sleep Phase Syndrome
2 CompletedClinical Trials

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,130 Previous Clinical Trials
35,668,850 Total Patients Enrolled
2 Trials studying Delayed Sleep Phase Syndrome
300 Patients Enrolled for Delayed Sleep Phase Syndrome
University of California, San FranciscoOTHER
2,245 Previous Clinical Trials
11,473,566 Total Patients Enrolled
Emmanuel Mignot, MD, PhDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Delayed Sleep Phase Syndrome
200 Patients Enrolled for Delayed Sleep Phase Syndrome

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 years of age or older.
Subjects are unable to fall asleep if trying to sleep before the later bedtime.
You are willing and able to comply with all aspects of the protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.