Clinical trial NCT05166590: Sleep and Social Experiences Study 2
Official title: Sleep Loss, Cardiovascular Physiology, and Social Experiences Study
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: 2021-12-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will be randomized to a night of normal sleep (8 hours) or total sleep restriction.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in blood pressure post-rejection
timeFrame: Baseline to post final rejection (cooperative task) an average of 32 minutes
Secondary outcomes:
measure: Change in pre-ejection period (PEP) in response to rejection task
timeFrame: Baseline to Post-rejection task, anticipated average of 42 minutes
measure: Change in heart rate variability (HRV) in response to rejection task
timeFrame: Baseline to Post-rejection task, anticipated average of 42 minutes
measure: Change in affect
timeFrame: Evening baseline to post-rejection task, time period of approximately 13 hours
measure: Risk-taking
timeFrame: Immediately after final social rejection task, approximately at hour 13 of the overnight in-lab visit
measure: Trust (of outgroup partner)
timeFrame: Public Goods game will be played after the Columbia Card Task, post-social rejection, approximately at hour 13 of the overnight in-lab visit
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: