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 range
20 Years – 60 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary