Sleep Disorder, Shift-WorkPhase 4NCT02491788

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

A Phase 4 study testing Suvorexant in people with Sleep Disorder, Shift-Work, run by VA Palo Alto Health Care System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Disorder, Shift-Work
What is being tested?: Suvorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2016to 1 Aug 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Palo Alto Health Care System
Palo Alto, California, 94304

Other trials in United States

About this study

Conditions: Sleep Disorder, Shift-Work
Being tested: Suvorexant, Placebo
Medical subject headings: Sleep Disorders, Circadian Rhythm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SuvorexantDrug
Also called Belsomra
PlaceboDrug

Study groups in NCT02491788
Study group	Role	What they receive
Drug	Experimental	10 mg of suvorexant 30 minutes prior to daytime sleep opportunity Receives: Drug: Suvorexant
Placebo	Placebo comparator	Placebo pill 30 minutes prior to daytime sleep opportunity Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Daytime sleep will be examined from baseline to after 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20161 Aug 2019

First posted8 Jul 2015 (estimated)
Study start1 Feb 2016
Primary completion1 Aug 2019
Study completion1 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sleep Disorder, Shift-WorkStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02491788
Sponsor's protocol ID: IRB-34778
Status last verified: Jun 2020
First submitted: 1 Jul 2015
Last updated: 1 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: All relevant data will be provided in the publication

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.
PubMed 32484552

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
ClinicalTrials.gov ID: NCT02491788
Acronym / sponsor ID: IRB-34778
Conditions: Sleep Disorder, Shift-Work
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: VA Palo Alto Health Care SystemUS federal agency
Collaborators: Merck Sharp & Dohme LLC, Stanford University
Study start: 1 Feb 2016 (actual)
Primary completion: 1 Aug 2019 (actual)
Study completion: 1 Aug 2019 (actual)
First posted: 8 Jul 2015 (estimated)
Results: Posted 16 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Drug	Experimental	Drug: Suvorexant10 mg of suvorexant 30 minutes prior to daytime sleep opportunity
Placebo	Placebo comparator	Drug: PlaceboPlacebo pill 30 minutes prior to daytime sleep opportunity

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Aged 20-60 (older individuals excluded due to altered sleep-related circadian signaling)
Males and females
Shift worker
Presence of DSM-5 defined Circadian Rhythm Sleep-Wake Disorder: Shift Work Type

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SuvorexantAlso: Belsomra	Drug	Drug
Placebo	Drug	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 16 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drug	8	8
Placebo	11	11

Primary outcome: Change in Average Total Sleep Time

Time frame: Daytime sleep will be examined from baseline to after 3 weeks. Mean (Standard Error). Unit: hours/sleep opportunity

Measure	Drug n = 8	Placebo n = 11
Value	1.83 (0.62)	-0.33 (0.49)

Drug vs Placebo: Mean Difference (Final Values): 2.16, p <0.05, Mixed Models Analysis

Adverse events

Time frame: 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Placebo	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32484552Zeitzer 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.
Individual participant dataSharing planned: No. All relevant data will be provided in the publication

Related trials for Sleep Disorder, Shift-Work

Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Suvorexant in people with Sleep Disorder, Shift-Work, run by VA Palo Alto Health Care System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Average Total Sleep Time (time frame: Daytime sleep will be examined from baseline to after 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02491788, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.