Trial Outcomes & Findings for Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers (NCT NCT02491788)

NCT ID: NCT02491788

Last Updated: 2020-07-01

Results Overview

Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: Daytime sleep will be examined from baseline to after 3 weeks
• Results posted on: 2020-07-01

Participant Flow

Participant milestones

Measure	Drug 10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity Suvorexant	Placebo Placebo pill 30 minutes prior to daytime sleep opportunity Placebo
Overall Study STARTED	8	11
Overall Study COMPLETED	8	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Drug n=8 Participants 10 mg of suvorexant 30 minutes prior to daytime sleep opportunity Suvorexant	Placebo n=11 Participants Placebo pill 30 minutes prior to daytime sleep opportunity Placebo	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41.4 years STANDARD_DEVIATION 12.9 • n=5 Participants	35.1 years STANDARD_DEVIATION 9.33 • n=7 Participants	37.7 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	11 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Drug n=8 Participants 10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity Suvorexant	Placebo n=11 Participants Placebo pill 30 minutes prior to daytime sleep opportunity Placebo
Change in Average Total Sleep Time	1.83 hours/sleep opportunity Standard Error 0.62	-0.33 hours/sleep opportunity Standard Error 0.49

Adverse Events

Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Drug n=8 participants at risk 10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity Suvorexant	Placebo n=11 participants at risk Placebo pill 30 minutes prior to daytime sleep opportunity Placebo
Musculoskeletal and connective tissue disorders Facial swelling	0.00% 0/8 • 5 weeks Weekly and ad libitum telephone assessment with project coordinator	9.1% 1/11 • Number of events 1 • 5 weeks Weekly and ad libitum telephone assessment with project coordinator
Nervous system disorders Fatigue	0.00% 0/8 • 5 weeks Weekly and ad libitum telephone assessment with project coordinator	9.1% 1/11 • Number of events 1 • 5 weeks Weekly and ad libitum telephone assessment with project coordinator

Additional Information

Dr. Jamie Zeitzer

Stanford University

Phone: 16504935000

Email: jzeitzer@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place