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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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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, 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.

Condition or disease Intervention/treatment Phase
Shift-Work Related Sleep Disturbance Drug: Lemborexant Drug: Placebo Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Lemborexant

Arm Intervention/treatment
Experimental: Active Treatment
Participants randomized into this arm will receive Lemborexant (5-10mg).
Drug: Lemborexant
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.
Drug: Placebo
A placebo that looks and tastes like Lemborexant tablets




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Cara A Woodworth, BA 415-476-6618 cara.woodworth@ucsf.edu
Contact: Aric Prather, PhD 415-476-7758 aric.prather@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Aric Prather, PhD    415-476-7758    aric.prather@ucsf.edu   
Contact: Cara A Woodworth, BA    415-476-6618    cara.woodworth@ucsf.edu   
Principal Investigator: Aric Prather, PhD         
Sub-Investigator: Andrew Krystal, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Aric Prather, PhD University of California, San Francisco
Additional Information:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05344443    
Other Study ID Numbers: 20-32763
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
Shift Work
Daytime Sleepiness
Lemborexant
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Lemborexant
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs