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

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ClinicalTrials.gov Identifier: NCT02491788
Recruitment Status : Completed
First Posted : July 8, 2015
Results First Posted : June 16, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Stanford University
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sleep Disorder, Shift-Work
Interventions Drug: Suvorexant
Drug: Placebo
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drug Placebo
Hide Arm/Group Description

10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity

Suvorexant

Placebo pill 30 minutes prior to daytime sleep opportunity

Placebo

Period Title: Overall Study
Started 8 11
Completed 8 11
Not Completed 0 0
Arm/Group Title Drug Placebo Total
Hide Arm/Group Description

10 mg of suvorexant 30 minutes prior to daytime sleep opportunity

Suvorexant

Placebo pill 30 minutes prior to daytime sleep opportunity

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 8 11 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
11
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 11 participants 19 participants
41.4  (12.9) 35.1  (9.33) 37.7  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
Female
3
  37.5%
3
  27.3%
6
  31.6%
Male
5
  62.5%
8
  72.7%
13
  68.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
  27.3%
3
  15.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   9.1%
1
   5.3%
Black or African American
1
  12.5%
1
   9.1%
2
  10.5%
White
5
  62.5%
5
  45.5%
10
  52.6%
More than one race
1
  12.5%
0
   0.0%
1
   5.3%
Unknown or Not Reported
1
  12.5%
1
   9.1%
2
  10.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 11 participants 19 participants
8 11 19
1.Primary Outcome
Title Change in Average Total Sleep Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug Placebo
Hide Arm/Group Description:

10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity

Suvorexant

Placebo pill 30 minutes prior to daytime sleep opportunity

Placebo

Overall Number of Participants Analyzed 8 11
Mean (Standard Error)
Unit of Measure: hours/sleep opportunity
1.83  (0.62) -0.33  (0.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drug, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.75
Estimation Comments [Not Specified]
Time Frame 5 weeks
Adverse Event Reporting Description Weekly and ad libitum telephone assessment with project coordinator
 
Arm/Group Title Drug Placebo
Hide Arm/Group Description

10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity

Suvorexant

Placebo pill 30 minutes prior to daytime sleep opportunity

Placebo

All-Cause Mortality
Drug Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
Drug Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drug Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      2/11 (18.18%)    
Musculoskeletal and connective tissue disorders     
Facial swelling  [1]  0/8 (0.00%)  0 1/11 (9.09%)  1
Nervous system disorders     
Fatigue  [2]  0/8 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Participant felt that facial swelling occurred contemporaneously with onset of taking the study medication (placebo). Participant decided to remain in study. Unblinding was not revealed to participant or study team who assessed the data.
[2]
Participant felt taking the study medication (placebo) made it more difficult to run in the evening. Participant decided to remain in study. Unblinding was not revealed to participant or study team who assessed the data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jamie Zeitzer
Organization: Stanford University
Phone: 16504935000
EMail: jzeitzer@stanford.edu
Layout table for additonal information
Responsible Party: Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT02491788    
Other Study ID Numbers: IRB-34778
First Submitted: July 1, 2015
First Posted: July 8, 2015
Results First Submitted: May 26, 2020
Results First Posted: June 16, 2020
Last Update Posted: July 1, 2020