Sleep Disorder, Shift-Work
Conditions
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.
Interventions
DRUGSuvorexant
DRUGPlacebo
Sponsors
Merck Sharp & Dohme LLC
Stanford University
VA Palo Alto Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Total Sleep Time | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug 10 mg of suvorexant 30 minutes prior to daytime sleep opportunity
Suvorexant | 8 |
| Placebo Placebo pill 30 minutes prior to daytime sleep opportunity
Placebo | 11 |
| Total | 19 |
Baseline characteristics
| Characteristic | Placebo | Total | Drug |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 19 Participants | 8 Participants |
| Age, Continuous | 35.1 years STANDARD_DEVIATION 9.33 | 37.7 years STANDARD_DEVIATION 11.1 | 41.4 years STANDARD_DEVIATION 12.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 11 participants | 19 participants | 8 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 11 |
| other Total, other adverse events | 0 / 8 | 2 / 11 |
| serious Total, serious adverse events | 0 / 8 | 0 / 11 |
Outcome results
Primary
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
Time frame: Daytime sleep will be examined from baseline to after 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug | Change in Average Total Sleep Time | 1.83 hours/sleep opportunity | Standard Error 0.62 |
| Placebo | Change in Average Total Sleep Time | -0.33 hours/sleep opportunity | Standard Error 0.49 |
p-value: <0.05Mixed Models Analysis