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Completed

NCT Number: NCT03937973

Social Experiences and Sleep Study

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.

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Key information

Conditions

Sleep Blood Pressure

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Social rejection

Behavioral

Social rejection paradigm

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

The Effects of Social Experiences on Sleep and Cardiovascular Functioning

Acronym: SASE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 6, 2019
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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