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Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers

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ClinicalTrials.gov Identifier: NCT02491788
Recruitment Status : Completed
First Posted : July 8, 2015
Results First Posted : June 16, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Stanford University
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 8, 2015
Results First Submitted Date  ICMJE May 26, 2020
Results First Posted Date  ICMJE June 16, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE February 1, 2016
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
Change in Average Total Sleep Time [ Time Frame: Daytime sleep will be examined from baseline to after 3 weeks ]
Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Average Total Sleep Time [ Time Frame: Daytime sleep will be examined over three weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working overnight shifts will significantly improve both objective (total sleep time, sleep efficiency, wake after sleep onset) and subjective (sleep quality) measures of daytime sleep.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sleep Disorder, Shift-Work
Intervention  ICMJE
  • Drug: Suvorexant
    Other Name: Belsomra
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Drug
    10 mg of suvorexant 30 minutes prior to daytime sleep opportunity
    Intervention: Drug: Suvorexant
  • Placebo Comparator: Placebo
    Placebo pill 30 minutes prior to daytime sleep opportunity
    Intervention: Drug: Placebo
Publications * Zeitzer JM, Joyce DS, McBean A, Quevedo YL, Hernandez B, Holty JE. Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206614. doi: 10.1001/jamanetworkopen.2020.6614.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2020)
19
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2015)
38
Actual Study Completion Date  ICMJE August 1, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 20-60 (older individuals excluded due to altered sleep-related circadian signaling)
  • Males and females
  • Shift worker

    • Minimum of three months of prior shift work
    • Will work minimum of four nights per week or 32 hours of night shift per week during study
    • "Night work" defined as having at least six hours of work occurring between 8 PM and 8 AM and no longer than 12 hours on shift
  • Presence of DSM-5 defined Circadian Rhythm Sleep-Wake Disorder: Shift Work Type

    • Insomnia (SE < 88%) during attempted daytime sleep or excessive sleepiness during nocturnal wake

Exclusion Criteria:

  • Currently or planning to become pregnant
  • Currently breastfeeding
  • Inadequate opportunity (<7 hours) for daytime sleep after shift work
  • Use of sleep aids during the study period. Includes as needed or continuous use of prescription, non-prescription, and naturopathic pharmacotherapies
  • Diagnosis or detection (during study) of sleep disordered breathing (AHI>10) on home sleep testing; referral to clinical sleep program will be offered
  • Diagnosis of narcolepsy
  • Restless Legs Syndrome
  • >600 mg caffeine intake per night shift or use of prescription stimulant medication during night shift
  • Rotational or irregular work shifts during study
  • Use of digoxin for six months prior to or during study
  • Use of strong (e.g., etoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan) or moderate (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) CYP3A inhibitors or CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin) for six months prior to or during study
  • Severe hepatic impairment
  • Unstable or severe medical or psychiatric condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02491788
Other Study ID Numbers  ICMJE IRB-34778
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: All relevant data will be provided in the publication
Responsible Party Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
Study Sponsor  ICMJE VA Palo Alto Health Care System
Collaborators  ICMJE
  • Merck Sharp & Dohme Corp.
  • Stanford University
Investigators  ICMJE Not Provided
PRS Account VA Palo Alto Health Care System
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP