跳至主要内容
临床试验/NCT05166590
NCT05166590已完成不适用

Sleep Loss, Cardiovascular Physiology, and Social Experiences Study

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2021年6月1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
77
试验地点
2
主要终点
Change in blood pressure post-rejection

研究概览

简要总结

This study aims to to test effects of sleep loss on perceived discrimination and cardiovascular functioning as well as identify moderators of the racial discrimination and objective sleep link in a sample of 80 African Americans.

详细描述

African Americans (AAs) are disproportionately burdened by clinical and subclinical cardiovascular disease (CVD) when compared to European Americans (EAs), and while experiences of racial discrimination have been associated with CVD morbidity among AAs, including high daytime and nighttime blood pressure, the mechanisms underlying these associations are unclear. Poor sleep, such as short sleep duration and poor sleep continuity, may serve as a novel pathway; however, this possibility has not been rigorously tested. Evidence linking racial discrimination and poor sleep is mounting, however, largely derived from cross-sectional studies. Further, researchers have largely ignored the possibility of reciprocal effects. In a separate study (CHR#:18-24889) the investigators are testing the effects of perceived discrimination on sleep and nocturnal physiology. In this study, however, the investigators aim to test whether the other direction- whether experimental sleep loss affects one's perception and reaction to social interaction tasks with an outgroup member (White participant). To this end, the investigators will randomize 80 healthy AAs to one night of total sleep restriction or normal sleep in the sleep laboratory and then expose them to several standardized social experience tasks. These tasks include a digit span task, social evaluative speech task and cooperative task (i.e., playing Taboo), all of which will occur in the context of subtle negative evaluative feedback from the White confederate. Cardiovascular functioning as well as self-reported affect will be measured throughout the tasks and potential moderators, including socioeconomic status and race-based rejection sensitivity, will be tested. This study will fill fundamental gap in the scientific literature and provide the critical causal and mechanistic evidence necessary to address racial disparities in sleep and cardiovascular risk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants will be blind to their condition up until right before they begin their night of normal sleep or total restriction. Participants will also be blind to the nature of the social-rejection task until the debriefing.

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 old 64 years old
  • Self-identified African American/Black
  • English speaking, able to provide informed consent
  • Self-reported bedtime between 10 PM and 12 AM for 5/7 nights for the past 3-months (stability to be confirmed by actigraphy and sleep diary)
  • Self-reported sleep duration of 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

  • Aged greater than 64 years (to minimize age-related differences in sleep quantity and architecture).
  • Body mass index of 40 or above (to exclude for obesity, which can impair physiologic recording and confound study outcomes).
  • Presence of any clinical sleep disorder, including insomnia and obstructive sleep apnea (OSA), as assessed by validated screening measure. OSA will also be assessed objectively during the Sleep Screening period.
  • Medical or psychiatric condition, as assessed by self-report and clinical interview, that is likely to affect sleep/wake function 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/wake function or cardiovascular functioning, including antidepressants, anxiolytic or soporific medication, and beta-blockers.

研究组 & 干预措施

Normal Sleep

No Intervention

Participants will sleep in the laboratory for 8 hours and then undergo the same social-rejection paradigm as the experimental group to serve as a control comparison.

Total Sleep Restriction

Experimental

Participants will experience a night of total sleep restriction and then undergo a social-rejection task in the morning.

干预措施: Sleep Restriction (Behavioral)

结局指标

主要结局

Change in blood pressure post-rejection

时间窗: Baseline to post final rejection (cooperative task) an average of 32 minutes

Both systolic and diastolic blood pressure is measured via blood pressure arm cuff, taken after a 5-minute resting period and after each social interaction task

次要结局

  • Change in pre-ejection period (PEP) in response to rejection task(Baseline to Post-rejection task, anticipated average of 42 minutes)
  • Change in heart rate variability (HRV) in response to rejection task(Baseline to Post-rejection task, anticipated average of 42 minutes)
  • Risk-taking(Immediately after final social rejection task, approximately at hour 13 of the overnight in-lab visit)
  • Change in affect(Evening baseline to post-rejection task, time period of approximately 13 hours)
  • Trust (of outgroup partner)(Public Goods game will be played after the Columbia Card Task, post-social rejection, approximately at hour 13 of the overnight in-lab visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验