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



Status:Recruiting
Healthy:No
Age Range:20 - 60
Updated:1/7/2018
Start Date:February 2016
End Date:December 2018
Contact:Yvonne Quevedo
Email:pavasleepstudy@gmail.com
Phone:650-493-5000

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
1
site
3801 Miranda Avenue
Palo Alto, California 94304
650-493-5000
Principal Investigator: Jamie M Zeitzer, PhD
VA Palo Alto Health Care System The VA Palo Alto Health Care System (VAPAHCS) consists...
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials