Social Experiences and Sleep Study (SASE)

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

Tracking Information

• First Submitted Date: April 15, 2019
• First Posted Date: May 6, 2019
• Last Update Posted Date: July 29, 2022
• Actual Study Start Date: April 9, 2019
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 8, 2021)

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

Original Primary Outcome Measures (submitted: May 1, 2019)

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" in the sleepon the nights following the social rejection task and the control task laboratory to onset of sleep, as measured via polysomnography

Current Secondary Outcome Measures (submitted: May 1, 2019)

• 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
• 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
• 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
• 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
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Social Experiences and Sleep Study
• Official Title: The Effects of Social Experiences on Sleep and Cardiovascular Functioning
• 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.
• 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
• Study Phase: Not Applicable

Study Design

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

Condition

• Sleep
• Blood Pressure

Intervention

Behavioral: Social rejection

Social rejection paradigm

Study Arms

• 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).
  Intervention: Behavioral: Social rejection
• 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).
  Intervention: Behavioral: Social rejection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 1, 2019): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Rebecca Dileo; 4154767758; rebecca.dileo@ucsf.edu

Contact: Emelly Argueta; emelly.argueta@ucsf.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03937973
• Other Study ID Numbers: 18-24889; R01HL142051 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Analytic Code
• Time Frame: All processed data should be available within 5 years of completion of the study
• Access Criteria: Consistent with NIH guidelines

• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Aric Prather, University of California, San Francisco, Associate Professor of Psychiatry
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Aric A Prather, PhD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: July 2022