SleepSASE2NCT05166590
Sleep and Social Experiences Study 2
A study testing Sleep Restriction in people with Sleep and Blood Pressure, run by University of California, San Francisco at 1 site in United States.
Trial 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. 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?
- Sleep Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 15 Oct 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 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)
Who cannot join
- 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.
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: Sleep Loss, Cardiovascular Physiology, and Social Experiences Study
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.
Read the 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.
- Conditions
- Sleep, Blood Pressure
- Being tested
- Sleep Restriction
- Keywords
- sleep, heart, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep RestrictionBehavioural
Sleep Deprivation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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 42 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 42 minutes
Change in affect
Affect will be measured through the Positive and Negative Affect Scale (PANAS) at multiple timepoints in the study. The PANAS score is calculated by finding the sum of the 10 positive items, and then the 10 negative items. Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
Measured: Evening baseline to post-rejection task, time period of approximately 13 hours
Risk-taking
Risk-taking post-social rejection will be measured through performance on the Columbia Card Task (hot version), a card game in which they can choose to turn over cards for points. Each card could either be a gain or loss card, but this is unknown until the card is turned over. Turning over gain cards result in point increases while turning over loss cards result in point decreases. Performance is scored by the average number of cards research subjects choose to turn over. Higher average scores (more cards turned over) reflect increased risk-taking. The average is generated across 20 trials of the game, with each trial containing 32 cards in total.
Measured: Immediately after final social rejection task, approximately at hour 13 of the overnight in-lab visit
Trust (of outgroup partner)
Trust (of outgroup partner) will be measured via dollar amount shared in a "common pot" during a Public Goods game. Subjects will be told that they and their outgroup partner have the opportunity to further increase each of their monetary bonus by placing their money in a "common pot" that will be increased by 150% and split equally between them and their partner. Subjects can choose how much they would like to place in the common pot or choose to not share at all. Any money not placed in the common pot will be kept for themselves. Higher amounts (more dollars) shared in the "common pot" indicate higher levels of trust in the outgroup partner.
Measured: Public Goods game will be played after the Columbia Card Task, post-social rejection, approximately at hour 13 of the overnight in-lab visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Jun 2021
- Primary completion31 May 2025
- Study completion15 Oct 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
- Parallel groups
- Model description
- All participants will be randomized to a night of normal sleep (8 hours) or total sleep restriction.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 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
- NCT05166590
- Sponsor's protocol ID
- 18-25169
- Other IDs
- 5R01HL142051-03
- Acronym
- SASE2
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2021
- 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
- Sleep Loss, Cardiovascular Physiology, and Social Experiences Study
- ClinicalTrials.gov ID
- NCT05166590
- Acronym / sponsor ID
- SASE2 / 18-25169
- Conditions
- Sleep, Blood Pressure
- Keywords
- sleep, heart, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 22 Dec 2021 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will be randomized to a night of normal sleep (8 hours) or total sleep restriction.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Sleep RestrictionParticipants will experience a night of total sleep restriction and then undergo a social-rejection task in the morning. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Sleep RestrictionSleep Deprivation | Behavioural | Total Sleep Restriction |
Primary outcome
Change in blood pressure post-rejection
Time frame: Baseline to post final rejection (cooperative task) an average of 32 minutes
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
5 secondary outcomes
Change in pre-ejection period (PEP) in response to rejection task
Time frame: Baseline to Post-rejection task, anticipated average of 42 minutes
Change in heart rate variability (HRV) in response to rejection task
Time frame: Baseline to Post-rejection task, anticipated average of 42 minutes
Change in affect
Time frame: Evening baseline to post-rejection task, time period of approximately 13 hours
Risk-taking
Time frame: Immediately after final social rejection task, approximately at hour 13 of the overnight in-lab visit
Trust (of outgroup partner)
Time frame: Public Goods game will be played after the Columbia Card Task, post-social rejection, approximately at hour 13 of the overnight in-lab visit
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.
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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 Sleep Restriction 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 5 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 blood pressure post-rejection (time frame: Baseline to post final rejection (cooperative task) an average of 32 minutes). 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.