- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937973
Social Experiences and Sleep Study (SASE)
November 4, 2025 updated by: University of California, San Francisco
The Effects of Social Experiences on Sleep and Cardiovascular Functioning
This study will test the effect of race-based social rejection on polysomnography derived sleep outcomes and nocturnal cardiovascular psychophysiology in a sample of 80 African Americans and 80 Caucasian Americans.
The investigators will test group differences on these outcomes as well as within subjects by testing impact of rejection compared to a non-rejection control night in the sleep laboratory.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
African Americans (AA) are disproportionally burdened by cardiovascular disease compared to Caucasian Americans (CA).
Poor sleep, which is more common among AA, may serve as an important pathway in understanding these disparities.
Race-based rejection has been cross-sectionally related to poor sleep and negative cardiovascular outcomes.
To test the links between social experiences and sleep, participants will spend two nights in the sleep laboratory.
One night will be a control night where participants complete low arousal tasks prior to bedtime.
On a second night, the investigators will randomize 80 AA and 80 CA to either race-based social rejection (i.e., being rejected by an out-group member) or same-race social rejection prior to bedtime to test the causal influences of race-based rejection on objective sleep parameters, measured using polysomnography, and nocturnal cardiovascular functioning.
The investigators will test group differences on these outcomes as well as within subjects by testing impact of rejection compared to a non-rejection control night in the sleep laboratory.
The order of the control and rejection task night will be counterbalanced.
Study Type
Interventional
Enrollment (Actual)
139
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94118
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age: 18 to 64 years old
- Self-identified as African American/Black or Caucasian American/White
- English speaking, able to provide consent
- Self-reported bedtime between 10PM and 12AM for 5/7 nights for the past 3 months (stability to be confirmed by sleep diary and wrist actigraphy).
- Self-reported sleep duration between 6.5 and 8.5 hours for 5/7 nights for the last month (duration to be confirmed by actigraphy and sleep diary)
Exclusion Criteria:
- Body mass index of 40 or above
- Participants at high risk for obstructive sleep apnea, based on "high risk" score from the STOP-Bang.
- Medical or psychiatric condition, as assessed by self-report and clinical interview that affect sleep and/or cardiovascular functioning, including doctor diagnosed arrhythmia, hypertension, congestive heart failure, major depression, bipolar disorder, post-traumatic stress disorder.
- Medication use that is likely to affect sleep and/or cardiovascular functioning, including antidepressants, anxiolytic or soporific medication, and beta-blockers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Social rejection by in-group
One hour prior to bed, participants will be exposed to a social rejection paradigm that includes a computerized ball-tossing game (Cyberball) and a speech task.
Participants are made to believe that they are being rejected by someone of their own race/ethnicity (e.g., African American rejected by another African American).
|
Social rejection paradigm
|
|
Experimental: Social rejection by out-group
One hour prior to bed, participants will be exposed to a social rejection paradigm that includes a computerized ball-tossing game (Cyberball) and a speech task.
Participants are made to believe that they are being rejected by someone not of their own race/ethnicity (e.g., Caucasian American rejected by another African American).
|
Social rejection paradigm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sleep onset latency, as determined by polysomnography
Time Frame: Assessed on the night of the social rejection task and compared to the control task night; it is anticipated that these nights will take place consecutively
|
Sleep onset latency is the time (in minutes) from "lights out" to sleep onset on the nights following the social rejection task and the control task laboratory to onset of sleep, as measured via polysomnography
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Assessed on the night of the social rejection task and compared to the control task night; it is anticipated that these nights will take place consecutively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in minutes of wake after sleep onset (WASO), as determined by polysomnography
Time Frame: Assessed on the night of the social rejection task and the night of the control task; it is anticipated that these nights will take place consecutively
|
Number of minutes awake once sleep is initiated, measured via polysomnography on the nights following the social rejection task and the control task
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Assessed on the night of the social rejection task and the night of the control task; it is anticipated that these nights will take place consecutively
|
|
Change in total sleep time, as determined by polysomnography
Time Frame: Assessed on the night of the social rejection task and the night of the control task; it is anticipated that these nights will take place consecutively
|
Total number of minutes scored as sleep, measured via polysomnography on the nights following the social rejection task and the control task
|
Assessed on the night of the social rejection task and the night of the control task; it is anticipated that these nights will take place consecutively
|
|
Change in pre-ejection period (PEP) in response to rejection task
Time Frame: Baseline to Post-rejection task, anticipated average of 30 minutes
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Pre-ejection period is measured via impedance cardiography, averaged over a 5-minute baseline period and in the minutes during the rejection task
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Baseline to Post-rejection task, anticipated average of 30 minutes
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Change in heart rate variability (HRV) in response to rejection task
Time Frame: Baseline to Post-rejection task, anticipated average of 30 minutes
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Heart rate variability is measured via EKG, averaged over a 5-minute baseline period and in the minutes during the rejection task
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Baseline to Post-rejection task, anticipated average of 30 minutes
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Change in nocturnal heart rate variability
Time Frame: Assessed on the night of the social rejection task and the night of the control task; it is anticipated that these nights will take place consecutively
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Heart rate variability is measured via EKG, beginning at "lights out" and collected across the night following the rejection task and control task; it is anticipated that the two nights will occur consecutively.
|
Assessed on the night of the social rejection task and the night of the control task; it is anticipated that these nights will take place consecutively
|
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Change in nocturnal pre-ejection period
Time Frame: Assessed on the night of the social rejection task and the night of the control task; it is anticipated that the two nights will occur consecutively
|
Pre-ejection period will be measured by impedance cardiography, beginning at "lights out" and collected across the night following the rejection task and control task; it is anticipated that the two nights will occur consecutively.
|
Assessed on the night of the social rejection task and the night of the control task; it is anticipated that the two nights will occur consecutively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Aric A Prather, PhD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2019
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
May 31, 2025
Study Registration Dates
First Submitted
April 15, 2019
First Submitted That Met QC Criteria
May 1, 2019
First Posted (Actual)
May 6, 2019
Study Record Updates
Last Update Posted (Estimated)
November 6, 2025
Last Update Submitted That Met QC Criteria
November 4, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Our plan is to make all processed data available at the conclusion of the study in line with NIH guidelines
IPD Sharing Time Frame
All processed data should be available within 5 years of completion of the study
IPD Sharing Access Criteria
Consistent with NIH guidelines
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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