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OpenTrials
Completed

NCT Number: NCT02491788

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suvorexant

Drug

Other names: Belsomra

Placebo

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Collaborators

  • Merck Sharp & Dohme LLC
  • Stanford University

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2015
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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