Testing Lemborexant for sleep issues in night shift workers
Effect of a Dual Orexin Receptor Antagonist, Lemborexant, on Total Sleep Time in Shift Workers: a Randomized Controlled Trial
This study is testing if a new sleep medication called Lemborexant can help night shift workers get better daytime sleep.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05344443 on ClinicalTrials.gov |
What this trial studies
This Phase IV double-blind, placebo-controlled study aims to evaluate the effectiveness of Lemborexant, a dual orexin antagonist, in improving daytime sleep for full-time night shift workers experiencing sleep disturbances. Participants will be randomly assigned to receive either Lemborexant (5mg or 10mg) or a placebo, with the goal of assessing changes in daytime sleep duration. The study addresses a significant gap in effective treatments for insomnia and daytime sleepiness among shift workers, who often face misalignment between their sleep needs and circadian rhythms.
Who should consider this trial
Good fit: Ideal candidates are full-time night shift workers who have been employed in this role for at least three months and report difficulties with daytime sleep and excessive sleepiness.
Not a fit: Patients who have severe depressive symptoms, sleep disordered breathing, or extreme circadian preferences may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for night shift workers by enhancing their ability to sleep during the day.
How similar studies have performed: Previous studies have shown success with similar approaches using other orexin antagonists, indicating potential for Lemborexant to be effective as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Aric Prather, PhD — University of California, San Francisco
- Study coordinator: Kai A Woodworth, BA
- Email: kai.woodworth@ucsf.edu
- Phone: 415-476-6618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.