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

Primary Purpose

Sleep Disorder, Shift-Work

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suvorexant
Placebo
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder, Shift-Work

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug

Placebo

Arm Description

10 mg of suvorexant 30 minutes prior to daytime sleep opportunity

Placebo pill 30 minutes prior to daytime sleep opportunity

Outcomes

Primary Outcome Measures

Change in Average Total Sleep Time
Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline

Secondary Outcome Measures

Full Information

First Posted
July 1, 2015
Last Updated
June 29, 2020
Sponsor
VA Palo Alto Health Care System
Collaborators
Merck Sharp & Dohme LLC, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02491788
Brief Title
Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
Merck Sharp & Dohme LLC, Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Shift-Work

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug
Arm Type
Experimental
Arm Description
10 mg of suvorexant 30 minutes prior to daytime sleep opportunity
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill 30 minutes prior to daytime sleep opportunity
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Other Intervention Name(s)
Belsomra
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Average Total Sleep Time
Description
Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline
Time Frame
Daytime sleep will be examined from baseline to after 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All relevant data will be provided in the publication
Citations:
PubMed Identifier
32484552
Citation
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.
Results Reference
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Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers

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