Clinical trial NCT03937973: Social Experiences and Sleep Study
Official title: The Effects of Social Experiences on Sleep and Cardiovascular Functioning
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Blood Pressure
Keywords: sleep
heart
stress
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-05-06
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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)
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in sleep onset latency, as determined by polysomnography
timeFrame: 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:
measure: Change in minutes of wake after sleep onset (WASO), as determined by polysomnography
timeFrame: 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
measure: Change in total sleep time, as determined by polysomnography
timeFrame: 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
measure: Change in pre-ejection period (PEP) in response to rejection task
timeFrame: Baseline to Post-rejection task, anticipated average of 30 minutes
measure: Change in heart rate variability (HRV) in response to rejection task
timeFrame: Baseline to Post-rejection task, anticipated average of 30 minutes
measure: Change in nocturnal heart rate variability
timeFrame: 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
measure: Change in nocturnal pre-ejection period
timeFrame: 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
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Aric A Prather, PhD
role: PRINCIPAL_INVESTIGATOR
References: