SleepSASENCT03937973
Social Experiences and Sleep Study
A study testing Social rejection in people with Sleep and Blood Pressure, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Blood Pressure
- What is being tested?
- Social rejection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: The Effects of Social Experiences on Sleep and Cardiovascular Functioning
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.
Read the detailed description
African Americans (AA) are disproportionally burdened by cardiovascular disease compared to Caucasian Americans (CA). Poor sleep, which is more common among AA, may serve as an important pathway in understanding these disparities. Race-based rejection has been cross-sectionally related to poor sleep and negative cardiovascular outcomes. To test the links between social experiences and sleep, participants will spend two nights in the sleep laboratory. One night will be a control night where participants complete low arousal tasks prior to bedtime. On a second night, the investigators will randomize 80 AA and 80 CA to either race-based social rejection (i.e., being rejected by an out-group member) or same-race social rejection prior to bedtime to test the causal influences of race-based rejection on objective sleep parameters, measured using polysomnography, and nocturnal cardiovascular functioning. 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. The order of the control and rejection task night will be counterbalanced.
- Conditions
- Sleep, Blood Pressure
- Being tested
- Social rejection
- Keywords
- sleep, heart, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social rejectionBehavioural
Social rejection paradigm
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Social rejection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Number of minutes awake once sleep is initiated, measured via polysomnography on the nights following the social rejection task and the control task
Measured: 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
Total number of minutes scored as sleep, measured via polysomnography on the nights following the social rejection task and the control task
Measured: 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
Pre-ejection period is measured via impedance cardiography, averaged over a 5-minute baseline period and in the minutes during the rejection task
Measured: Baseline to Post-rejection task, anticipated average of 30 minutes
Change in heart rate variability (HRV) in response to rejection task
Heart rate variability is measured via EKG, averaged over a 5-minute baseline period and in the minutes during the rejection task
Measured: Baseline to Post-rejection task, anticipated average of 30 minutes
Change in nocturnal heart rate variability
Heart rate variability is measured via EKG, beginning at "lights out" and collected across the night following the rejection task and control task; it is anticipated that the two nights will occur consecutively.
Measured: 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 nocturnal pre-ejection period
Pre-ejection period will be measured by impedance cardiography, beginning at "lights out" and collected across the night following the rejection task and control task; it is anticipated that the two nights will occur consecutively.
Measured: Assessed on the night of the social rejection task and the night of the control task; it is anticipated that the two nights will occur consecutively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start9 Apr 2019
- Primary completion1 Apr 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Aric A Prather, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937973
- Sponsor's protocol ID
- 18-24889
- Other IDs
- R01HL142051
- Acronym
- SASE
- Status last verified
- Nov 2025
- First submitted
- 15 Apr 2019
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our plan is to make all processed data available at the conclusion of the study in line with NIH guidelines
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Social Experiences on Sleep and Cardiovascular Functioning
- ClinicalTrials.gov ID
- NCT03937973
- Acronym / sponsor ID
- SASE / 18-24889
- Conditions
- Sleep, Blood Pressure
- Keywords
- sleep, heart, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
African Americans (AA) are disproportionally burdened by cardiovascular disease compared to Caucasian Americans (CA). Poor sleep, which is more common among AA, may serve as an important pathway in understanding these disparities. Race-based rejection has been cross-sectionally related to poor sleep and negative cardiovascular outcomes. To test the links between social experiences and sleep, participants will spend two nights in the sleep laboratory. One night will be a control night where participants complete low arousal tasks prior to bedtime. On a second night, the investigators will randomize 80 AA and 80 CA to either race-based social rejection (i.e., being rejected by an out-group member) or same-race social rejection prior to bedtime to test the causal influences of race-based rejection on objective sleep parameters, measured using polysomnography, and nocturnal cardiovascular functioning. 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. The order of the control and rejection task night will be counterbalanced.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Social rejection by in-group | Experimental | Behavioral: Social rejectionOne 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). |
| Social rejection by out-group | Experimental | Behavioral: Social rejectionOne 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). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social rejectionSocial rejection paradigm | Behavioural | Social rejection by in-group, Social rejection by out-group |
Primary outcome
Change in sleep onset latency, as determined by polysomnography
Time frame: 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
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
6 secondary outcomes
Change in minutes of wake after sleep onset (WASO), as determined by polysomnography
Time frame: 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
Time frame: 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
Time frame: Baseline to Post-rejection task, anticipated average of 30 minutes
Change in heart rate variability (HRV) in response to rejection task
Time frame: Baseline to Post-rejection task, anticipated average of 30 minutes
Change in nocturnal heart rate variability
Time frame: 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 nocturnal pre-ejection period
Time frame: Assessed on the night of the social rejection task and the night of the control task; it is anticipated that the two nights will occur consecutively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: Yes. Our plan is to make all processed data available at the conclusion of the study in line with NIH guidelines
Related trials for Sleep
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aric A Prather, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social rejection in people with Sleep and Blood Pressure, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep onset latency, as determined by polysomnography (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.