Status:
RECRUITING
Lemborexant Shift Work Treatment Study
Lead Sponsor:
University of California, San Francisco
Conditions:
Shift-Work Related Sleep Disturbance
Eligibility:
All Genders
20-60 years
Phase:
PHASE4
Brief 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,...
Detailed Description
Insomnia and daytime sleepiness are common complaints among night shift workers. A meta-analysis on sleep in shift workers indicates that fixed night shift workers sleep, on average, 0.4 hours less th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05344443
Start Date
March 10 2022
End Date
June 30 2025
Last Update
June 27 2024
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143