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Active treatment condition for Shift Work Sleep Disorder

Phase 2
Recruiting
Research Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men with women partners of childbearing potential are also expected to practice effective barrier methods of contraception from the time of signing informed consent through the last dose of study drug and for 30 days after dosing stops
Men or women aged between 30 and 60 years, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the intervention
Awards & highlights

Study Summary

This trial aims to see if taking a 5 mg dose of lemborexant can help improve sleep during the day without causing excessive sleepiness when awake. The study will be conducted in a

Who is the study for?
This trial is for individuals with sleep disorders linked to their work schedules, like shift workers who struggle to sleep during the day. Participants should be healthy adults willing to follow a simulated night shift schedule in a lab setting.Check my eligibility
What is being tested?
The study tests if taking 5 mg of Lemborexant helps improve daytime sleep without causing drowsiness when awake. It's compared against a placebo over three days under lab conditions with constant monitoring.See study design
What are the potential side effects?
Possible side effects of Lemborexant include headache, dizziness, grogginess or feeling sleepy during times you need to be awake, and potential changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will use effective contraception during and for 30 days after the study.
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I am between 30 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total sleep duration (objective measure)
Wake after sleep onset (objective measure)
Secondary outcome measures
Total sleep duration (subjective measure)
Wake after sleep onset (subjective measure)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active treatment conditionActive Control1 Intervention
Lemborexant at a 5mg dose is delivered in a film-coated tablet
Group II: Placebo conditionPlacebo Group1 Intervention
Placebo is delivered in a film-coated tablet

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Who is running the clinical trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealLead Sponsor
12 Previous Clinical Trials
4,317 Total Patients Enrolled
~16 spots leftby Sep 2025
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