NCT06231641

The Effects of Lemborexant on the Ability to Sleep During Daytime

The Effects of Lemborexant on the Ability to Sleep During Daytime: A Feasibility Study to Evaluate the Potential of Lemborexant to Treat Shift Work Disorder

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Shift-Work Sleep Disorder

Interventions

Type	Name	Description
DRUG	Lemborexant 5 MG [Dayvigo]	Lemborexant 5 mg will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening.
OTHER	Matching Placebo	Matching placebo will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening.

Timeline

• Start date: 2024-01-11
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-01-30
• Last updated: 2026-04-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study