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

NCT02491788 | Completed Phase 4 Results DMC

• 1 other identifier: IRB-34778
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder, Shift-Work

Outcome Measures

Primary Outcomes (1)

• 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

  Daytime sleep will be examined from baseline to after 3 weeks

Study Arms (2)

Drug

EXPERIMENTAL

10 mg of suvorexant 30 minutes prior to daytime sleep opportunity

Drug: Suvorexant

Placebo

PLACEBO COMPARATOR

Placebo pill 30 minutes prior to daytime sleep opportunity

Drug: Placebo

Interventions

Suvorexant DRUG

Also known as: Belsomra

Drug

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead
• Merck Sharp & Dohme LLC: collaborator
• Stanford University: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 32484552 DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Jamie Zeitzer
• Organization: Stanford University

jzeitzer@stanford.edu

16504935000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 8, 2015
• Study Start: February 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 1, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)