The Effects of Lemborexant on the Ability to Sleep During Daytime (NCT06231641) | Clinical Trial Compass
TerminatedPhase 2
The Effects of Lemborexant on the Ability to Sleep During Daytime
Stopped: In agreement with all parties, we will close the project on March 31 due to recruitment challenges.
Canada5 participantsStarted 2024-01-11
Plain-language 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.
Who can participate
Age range20 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men or women aged between 20 and 65 years, inclusive
✓. Be willing and able to give informed consent for study participation
✓. Participants must not have done shiftwork in the past year
✓. Normal vital signs values are: oral body temperature between 36.1 and 37.5 ºC (95 and 99.5 °F), supine SBP between 90 and 140 mmHg inclusive; supine DBP between 55 and 90 mmHg inclusive; heart rate between 50 and 100 bpm inclusive.
✓. Be willing to comply with all study requirements and procedures for the duration of the study, including refraining from consuming alcohol 48 hours prior to each experimental visit and grapefruit products (juice or fruit itself), Seville orange, lime, pomelo, carambola and pomegranate during all the duration of the study (from Visit 1 to Visit 4).
✓. Women who:
✓. Self-reported bedtime was between 9 pm and midnight on 4-7 nights per week.
Exclusion criteria
✕. Body mass index \> 32 as calculated from the participant's height (m) and weight (kg); weight (kg)/square height (m²)
✕. 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.
What they're measuring
1
Total sleep duration (objective measure)
Timeframe: during the intervention
2
Wake after sleep onset (objective measure)
Timeframe: during the intervention
Trial details
NCT IDNCT06231641
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
✕. Any evidence of psychiatric disorder (including Beck Depression Inventory \[BDI\] ≥ 20 at screening, or a score of 3 on item related to suicidal ideas)
✕. Evidence of any clinically significant, or unstable, acute or chronically progressive medical or surgical disorder (including planned medical procedures that may impact sleep), or any condition that may interfere with the absorption, metabolism, distribution, or excretion of the study drug, or may affect the participant's safety
✕. Clinically significant and abnormal electrocardiogram (ECG; including QTc ≥ 450 ms for males, 460 ms for females) or a history of cardiovascular disease including poorly controlled hypertension, ischemic heart disease, arrhythmia, or severe heart failure