Social Experiences and Sleep Study
SASE
The Effects of Social Experiences on Sleep and Cardiovascular Functioning
2 other identifiers
interventional
139
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2019
CompletedFirst Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedNovember 6, 2025
November 1, 2025
6 years
April 15, 2019
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in sleep onset latency, as determined by polysomnography
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
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 Outcomes (6)
Change in minutes of wake after sleep onset (WASO), as determined by polysomnography
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
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
Baseline to Post-rejection task, anticipated average of 30 minutes
Change in heart rate variability (HRV) in response to rejection task
Baseline to Post-rejection task, anticipated average of 30 minutes
Change in nocturnal heart rate variability
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
- +1 more secondary outcomes
Study Arms (2)
Social rejection by in-group
EXPERIMENTALOne 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 by out-group
EXPERIMENTALOne 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).
Interventions
Social rejection paradigm
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94118, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Aric A Prather, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants will be blind to condition until the debriefing, which occurs the morning following the social-rejection task.
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2019
First Posted
May 6, 2019
Study Start
April 9, 2019
Primary Completion
April 1, 2025
Study Completion
May 31, 2025
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- All processed data should be available within 5 years of completion of the study
- Access Criteria
- Consistent with NIH guidelines
Our plan is to make all processed data available at the conclusion of the study in line with NIH guidelines