NCT03937973

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

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

April 9, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

6 years

First QC Date

April 15, 2019

Last Update Submit

November 4, 2025

Conditions

Keywords

sleepheartstress

Outcome Measures

Primary Outcomes (1)

  • Change in sleep onset latency, as determined by polysomnography

    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

    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

Secondary Outcomes (6)

  • 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 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 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

  • +1 more secondary outcomes

Study Arms (2)

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).

Behavioral: Social rejection

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).

Behavioral: Social rejection

Interventions

Social rejection paradigm

Social rejection by in-groupSocial rejection by out-group

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be blind to condition until the debriefing, which occurs the morning following the social-rejection task.
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: All participants will complete two nights in the sleep laboratory. One night will be a non-rejection control night. The other night will be a rejection task night. In this regard, African American and Caucasian American participants will be randomized to one of two conditions. All participants will be exposed to social rejection prior to bedtime; however, they will either be rejected by a person of their own race (in-group member) or a different race (out-group member)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

May 6, 2019

Study Start

April 9, 2019

Primary Completion

April 1, 2025

Study Completion

May 31, 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