COMPLETED

Lemborexant Shift Work Treatment Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of a Dual Orexin Receptor Antagonist, Lemborexant, on Total Sleep Time in Shift Workers: a Randomized Controlled Trial

Quick Facts

Study Start:2022-03-10
Study Completion:2024-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05344443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Full-time night shift work (at least 6 hours per shift, 4 days per week or 32 hours per week)
  2. * Employed as a night shift worker for at least 3 months
  3. * Self-reported concerns about daytime sleepiness and difficulty sleeping during the daytime
  1. * Pregnancy (verified by urine pregnancy test) or plan to become pregnant in the next 3 months
  2. * Currently breastfeeding
  3. * Inadequate opportunity for sleep during the daytime (\< 7 hours opportunity) after overnight shift
  4. * Extreme circadian preference (based on Horne \& Ostberg Morningness-Eveningness Questionnaire)
  5. * Severe depressive symptoms (\>25 on CES-D)
  6. * Unwillingness to discontinue sleep aids (prescription or non-prescription) during the study period
  7. * Presence of sleep disordered breathing (verified by Apnea link)
  8. * Self-reported diagnosis of narcolepsy, restless legs syndrome
  9. * Self-reported intake of \>600mg of caffeine per night shift or use of stimulants during night shift, rotational, or irregular shifts
  10. * Unstable or untreated medical or psychiatric condition based on clinical interview.
  11. * Severe hepatic or renal impairment (based on chemistry panel);
  12. * 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

Contacts and Locations

Principal Investigator

Aric Prather, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Aric Prather, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-10
Study Completion Date2024-11-30

Study Record Updates

Study Start Date2022-03-10
Study Completion Date2024-11-30

Terms related to this study

Keywords Provided by Researchers

  • Shift Work
  • Daytime Sleepiness
  • Lemborexant

Additional Relevant MeSH Terms

  • Shift-Work Related Sleep Disturbance