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Social Experiences and Sleep Study (SASE)

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ClinicalTrials.gov Identifier: NCT03937973
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : July 29, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Blood Pressure Behavioral: Social rejection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: All participants will complete two nights in the sleep laboratory. One night will be a non-rejection control night. The other night will be a rejection task night. In this regard, African American and Caucasian American participants will be randomized to one of two conditions. All participants will be exposed to social rejection prior to bedtime; however, they will either be rejected by a person of their own race (in-group member) or a different race (out-group member)
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be blind to condition until the debriefing, which occurs the morning following the social-rejection task.
Primary Purpose: Basic Science
Official Title: The Effects of Social Experiences on Sleep and Cardiovascular Functioning
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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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).
 Behavioral: Social rejection
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).
 Behavioral: Social rejection
Social rejection paradigm


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in pre-ejection period (PEP) in response to rejection task [ Time Frame: Baseline to Post-rejection task, anticipated average of 30 minutes ]
    Pre-ejection period is measured via impedance cardiography, averaged over a 5-minute baseline period and in the minutes during the rejection task

  4. Change in heart rate variability (HRV) in response to rejection task [ Time Frame: Baseline to Post-rejection task, anticipated average of 30 minutes ]
    Heart rate variability is measured via EKG, averaged over a 5-minute baseline period and in the minutes during the rejection task

  5. 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 ]
    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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937973


Contacts
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Contact: Rebecca Dileo 4154767758 rebecca.dileo@ucsf.edu
Contact: Emelly Argueta emelly.argueta@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94118
Contact: Rebecca Dileo       rebecca.dileo@ucsf.edu   
Contact: Aric Prather, PhD    4154767758    aric.prather@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Aric A Prather, PhD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03937973    
Other Study ID Numbers: 18-24889
R01HL142051 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Our plan is to make all processed data available at the conclusion of the study in line with NIH guidelines
Supporting Materials: Study Protocol
Statistical Analysis Plan (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
sleep
heart
stress