Summary

Eligibility
for people ages 20-60 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Aric Prather, PhD
Headshot of Aric Prather
Aric Prather

Description

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.

Official Title

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

Details

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 than fixed day shift workers, while rotating shift workers sleep on average 1 hour less than fixed day shift workers. While there may be several reasons for sleep difficulties and sleep loss among shift workers, the misalignment of one's sleep preference (i.e., goal of sleeping during the day) and one's circadian rhythm (i.e., endogenous rhythm that signals the body to be awake during the day) is thought to be a primary cause. Insufficient sleep among night shift and rotating shift workers is linked with significant health consequences, including elevated risk for cardiovascular disease and cancer. Effective sleep treatments in shift workers are lacking. However, a recent randomized study of Suvorexant (20mg), a hypocretin/orexin receptor antagonist, produced a significant improvement in daytime total sleep time compared to placebo. Available evidence suggests that the reason Suvorexant is effective is because it blocks the hypocretin/orexin receptors that mediate signaling from the biological clock (suprachiasmatic nucleus of the hypothalamus) attempting to maintain sustained wakefulness during the biological day. As Lemborexant is also a hypocretin/orexin antagonist, it would also be expected to improve daytime sleep in shift workers but would have the advantage over Suvorexant of being highly effective in the dosages available for clinical use. As such, Lemborexant is ideally positioned to be an effective and important treatment of sleep problems in shift workers. 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. This will be a 4-week double blinded placebo controlled trial (2 weeks of baseline assessment followed by 2-weeks of treatment/placebo). The trial design is based on a recent successful study of the treatment of sleep problems in shift workers with a hypocretin/orexin receptor antagonist.

Keywords

Shift-Work Related Sleep Disturbance Shift Work Daytime Sleepiness Lemborexant Dyssomnias Parasomnias

Eligibility

You can join if…

Open to people ages 20-60

  • 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

You CAN'T join if...

  • 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

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Aric Prather, PhD
    Associate Professor, Psychiatry, School of Medicine. Authored (or co-authored) 99 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Study Screener
ID
NCT05344443
Phase
Phase 4 Sleep Disorders Research Study
Study Type
Interventional
Participants
Expecting 45 study participants
Last Updated