Lemborexant Shift Work Treatment Study
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|ClinicalTrials.gov Identifier: NCT05344443|
Recruitment Status : Recruiting
First Posted : April 25, 2022
Last Update Posted : April 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Shift-Work Related Sleep Disturbance||Drug: Lemborexant Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of a Dual Orexin Receptor Antagonist, Lemborexant, on Total Sleep Time in Shift Workers: a Randomized Controlled Trial|
|Actual Study Start Date :||March 10, 2022|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Active Treatment
Participants randomized into this arm will receive Lemborexant (5-10mg).
A dual orexin antagonist
Other Name: Dayvigo
Placebo Comparator: Placebo Treatment
Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment.
A placebo that looks and tastes like Lemborexant tablets
- Changes in Daytime Total Sleep Time in Minutes Collected from the Consensus Sleep Diary [ Time Frame: Baseline and 2 Weeks ]Within-person changes in daytime total sleep time in minutes from baseline to 2 weeks. Daytime total sleep time is reported in minutes from a Consensus Sleep Diary, completed by participants daily.
- Changes in Daytime Total Sleep Time in Minutes Measured by Actigraphy [ Time Frame: Baseline and 2 Weeks ]Within-person changes in daytime total sleep time in minutes from baseline to 2 weeks. Daytime total sleep time is collected using daily actigraphy data from Actiwatches, which participants will wear for two weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05344443
|Contact: Cara A Woodworth, BAemail@example.com|
|Contact: Aric Prather, PhDfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Aric Prather, PhD 415-476-7758 email@example.com|
|Contact: Cara A Woodworth, BA 415-476-6618 firstname.lastname@example.org|
|Principal Investigator: Aric Prather, PhD|
|Sub-Investigator: Andrew Krystal, MD|
|Principal Investigator:||Aric Prather, PhD||University of California, San Francisco|