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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 LLC
Stanford University
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Disorder, Shift-Work Drug: Suvorexant Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Suvorexant

Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug
10 mg of suvorexant 30 minutes prior to daytime sleep opportunity
 Drug: Suvorexant
Other Name: Belsomra
Placebo Comparator: Placebo
Placebo pill 30 minutes prior to daytime sleep opportunity
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT02491788


Locations
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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Merck Sharp & Dohme LLC
Stanford University
  Study Documents (Full-Text)

Documents provided by Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System:
Study Protocol and Statistical Analysis Plan  [PDF] August 21, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jamie M. Zeitzer, Ph.D., Associate Professor, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT02491788    
Other Study ID Numbers: IRB-34778
First Posted: July 8, 2015    Key Record Dates
Results First Posted: June 16, 2020
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All relevant data will be provided in the publication
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases
 Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action