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临床试验/NCT03937973
NCT03937973已完成不适用

The Effects of Social Experiences on Sleep and Cardiovascular Functioning

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2019年4月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
2
主要终点
Change in sleep onset latency, as determined by polysomnography

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be blind to condition until the debriefing, which occurs the morning following the social-rejection task.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

研究组 & 干预措施

Social rejection by in-group

Experimental

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).

干预措施: Social rejection (Behavioral)

Social rejection by out-group

Experimental

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).

干预措施: Social rejection (Behavioral)

结局指标

主要结局

Change in sleep onset latency, as determined by polysomnography

时间窗: 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

次要结局

  • Change in total sleep time, as determined by polysomnography(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)
  • Change in pre-ejection period (PEP) in response to rejection task(Baseline to Post-rejection task, anticipated average of 30 minutes)
  • Change in minutes of wake after sleep onset (WASO), as determined by polysomnography(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)
  • Change in heart rate variability (HRV) in response to rejection task(Baseline to Post-rejection task, anticipated average of 30 minutes)
  • Change in nocturnal heart rate variability(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)
  • Change in nocturnal pre-ejection period(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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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