NCT05166590

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

4 years

First QC Date

December 8, 2021

Last Update Submit

November 4, 2025

Conditions

Keywords

sleepheartstress

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 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.

Behavioral: Sleep Restriction

Interventions

Sleep Deprivation

Total Sleep Restriction

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Aric A Prather, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

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
Model Details: All participants will be randomized to a night of normal sleep (8 hours) or total sleep restriction.
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

Our plan is to make all processed data available at the conclusion of the study in line with NIH guidelines.

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

Locations