Social Experiences and Sleep Study

Sleep Clinical Trial

— SASE  

Official title:

The Effects of Social Experiences on Sleep and Cardiovascular Functioning

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03937973
• Other study ID #: 18-24889
• Secondary ID: R01HL142051
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 139
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Sleep

Intervention

Behavioral:
• Social rejection
Social rejection paradigm

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in minutes of wake after sleep onset (WASO), as determined by polysomnography	Number of minutes awake once sleep is initiated, 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
Secondary	Change in total sleep time, as determined by polysomnography	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
Secondary	Change in pre-ejection period (PEP) in response to rejection task	Pre-ejection period is measured via impedance cardiography, averaged over a 5-minute baseline period and in the minutes during the rejection task	Baseline to Post-rejection task, anticipated average of 30 minutes
Secondary	Change in heart rate variability (HRV) in response to rejection task	Heart rate variability is measured via EKG, averaged over a 5-minute baseline period and in the minutes during the rejection task	Baseline to Post-rejection task, anticipated average of 30 minutes
Secondary	Change in nocturnal heart rate variability	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
Secondary	Change in nocturnal pre-ejection period	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