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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
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.
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.
CIUSSS du Nord de l'ile de Montreal (CIUSSS-NIM) - Hôpital du Sacré-Cœur de Montréal (HSCM)
Montreal, Quebec, Canada
Total sleep duration (objective measure)
Assess the efficacy of lemborexant compared to placebo on PSG measured total sleep time (TST) during daytime recovery sleep using the mean data of the second and third daytime sleep episodes in each condition.
Time frame: during the intervention
Wake after sleep onset (objective measure)
Assess the efficacy of lemborexant compared to placebo on polysomnographically (PSG) measured wake after sleep onset (WASO) during daytime recovery sleep using the mean data of the second and third daytime sleep episodes in each condition
Time frame: during the intervention
Total sleep duration (subjective measure)
Evaluate the participant-reported daytime recovery sleep quality, measured as subjective TST (sTST), under lemborexant in comparison to placebo using the mean data of the second and third daytime sleep episodes in each condition
Time frame: during the intervention
Wake after sleep onset (subjective measure)
Evaluate the participant-reported daytime recovery sleep quality, measured as subjective WASO (sWASO), under lemborexant in comparison to placebo using the mean data of the second and third daytime sleep episodes in each condition.
Time frame: during the intervention
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