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Clinical Trial Summary

This study aim to evaluate whether a dose of 5 mg of lemborexant, as compared to a placebo, may improve daytime recovery sleep, without producing lingering sleepiness during wakefulness, using a 3-day simulated night shift protocol in the lab under constant monitoring.


Clinical Trial Description

After being informed about the study and potential risks, all patients giving written informed conset will undergo 2 screening visits to determine eligibility for study entry. Selected participants will then stay twice in the lab (active treatment condition and placebo condition), each visit lasting approximately 4 days. Participants will stay awake across the night and sleep during the day. Only the experimental condition will be different between the two visits (lemborexant or placebo). These experimental visits will be double-blind, in counterbalanced order and separated by an interval of at least 2 weeks (washout period). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06231641
Study type Interventional
Source Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Contact Alex Desautels, M.D., Ph.D.
Phone 514-338-2692
Email alex.desautels@umontreal.ca
Status Recruiting
Phase Phase 2
Start date January 11, 2024
Completion date September 1, 2025

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