Sleep and Social Experiences Study 2
SASE2
Sleep Loss, Cardiovascular Physiology, and Social Experiences Study
2 other identifiers
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 8, 2021
CompletedFirst Posted
Study publicly available on registry
December 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2025
CompletedNovember 6, 2025
November 1, 2025
4 years
December 8, 2021
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in blood pressure post-rejection
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
Baseline to post final rejection (cooperative task) an average of 32 minutes
Secondary Outcomes (5)
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
Change in affect
Evening baseline to post-rejection task, time period of approximately 13 hours
Risk-taking
Immediately after final social rejection task, approximately at hour 13 of the overnight in-lab visit
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
Study Arms (2)
Normal Sleep
NO INTERVENTIONParticipants 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
EXPERIMENTALParticipants will experience a night of total sleep restriction and then undergo a social-rejection task in the morning.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94118, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Aric A Prather, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2021
First Posted
December 22, 2021
Study Start
June 1, 2021
Primary Completion
May 31, 2025
Study Completion
October 15, 2025
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- All processed data should be available within 5 years of completion of the study
- Access Criteria
- Consistent with NIH guidelines
Our plan is to make all processed data available at the conclusion of the study in line with NIH guidelines.