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Lemborexant for Shift Work Sleep Disorder
Montréal, Canada
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
Must not have
Presence of a sleep disorder, such as a diagnosis of insomnia, narcolepsy, sleep paralysis, active somnambulism (history of childhood somnambulism is accepted), hypnagogic/ hypnopompic hallucinations, and REM behavior disorder, will be excluded based on the clinical interview. For sleep apnea syndrome, an apnea-hypopnea index > 15 per hour of sleep on the first screening night will be used as an exclusion criterion. For periodic limb movement disorder, an index of periodic limb movements during sleep associated with an arousal > 15 per hour of sleep on the first screening night will be used as an exclusion criterion
History of epilepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the intervention
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
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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 belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a diagnosed sleep disorder like insomnia or sleep apnea.
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I have a history of epilepsy.
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I haven't used any over-the-counter sleep aids like melatonin or valerian root in the last week.
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I have severe liver problems.
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I have heart issues, including abnormal ECG results or uncontrolled high blood pressure.
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I have had a serious head injury or stroke in the past.
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I am not taking any strong medication that affects liver enzymes.
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I haven't taken any sleep or mood-altering drugs recently.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total sleep duration (objective measure)
Wake after sleep onset (objective measure)
Secondary study objectives
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
Find a Location
Closest Location:CIUSSS du Nord de l'ile de Montreal (CIUSSS-NIM) - Hôpital du Sacré-Cœur de Montréal (HSCM)· Montréal, Canada
Who is running the clinical trial?
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealLead Sponsor
16 Previous Clinical Trials
4,531 Total Patients Enrolled