Lemborexant Shift Work Treatment Study (NCT05344443) | Clinical Trial Compass
CompletedPhase 4
Lemborexant Shift Work Treatment Study
United States29 participantsStarted 2022-03-10
Plain-language summary
Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
Who can participate
Age range20 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Full-time night shift work (at least 6 hours per shift, 4 days per week or 32 hours per week)
* Employed as a night shift worker for at least 3 months
* Self-reported concerns about daytime sleepiness and difficulty sleeping during the daytime
Exclusion Criteria:
* Pregnancy (verified by urine pregnancy test) or plan to become pregnant in the next 3 months
* Currently breastfeeding
* Inadequate opportunity for sleep during the daytime (\< 7 hours opportunity) after overnight shift
* Extreme circadian preference (based on Horne \& Ostberg Morningness-Eveningness Questionnaire)
* Severe depressive symptoms (\>25 on CES-D)
* Unwillingness to discontinue sleep aids (prescription or non-prescription) during the study period
* Presence of sleep disordered breathing (verified by Apnea link)
* Self-reported diagnosis of narcolepsy, restless legs syndrome
* Self-reported intake of \>600mg of caffeine per night shift or use of stimulants during night shift, rotational, or irregular shifts
* Unstable or untreated medical or psychiatric condition based on clinical interview.
* Severe hepatic or renal impairment (based on chemistry panel);
* Self-reported use of digoxin or strong or moderate cytochrome P450 3A4 isozyme inhibitors or cytochrome P450 3A4 isozyme inducers for 6 months prior to or during the study
What they're measuring
1
Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary