Social Rejection for Sleep

(SASE Trial)

Overseen By Emelly Argueta

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Anxiolytics, Beta-blockers

Disqualifiers: Obesity, Sleep apnea, Hypertension, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

139 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, if you are taking medications that affect sleep or heart function, like antidepressants, anxiety meds, sleep aids, or beta-blockers, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Social rejection for sleep?

Research suggests that social interactions, whether positive or negative, can impact sleep quality. For instance, supportive social relationships are linked to better sleep, while social rejection is associated with poor sleep, indicating that social dynamics play a role in sleep health. ^{1 2 3 4 5}

How does the treatment for social rejection differ from other treatments for sleep issues?

The treatment for social rejection in the context of sleep issues is unique because it focuses on addressing social rejection sensitivity, which is linked to depression and emotional responses, rather than directly targeting sleep itself. This approach is novel as it considers the psychological and social factors that may indirectly affect sleep, unlike traditional sleep treatments that typically focus on sleep hygiene or medication. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Aric A Prather, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This study is for English-speaking African American/Black or Caucasian American/White individuals aged 18-64 who usually sleep between 6.5 and 8.5 hours a night, with bedtime from 10PM to midnight. They must be able to consent and not have conditions like severe sleep apnea, obesity (BMI of 40+), heart issues, major mental health disorders, or take medications affecting sleep/cardiovascular health.

Inclusion Criteria

I am a competent English speaker and can provide consent.

I usually sleep for about 6.5 to 8.5 hours a night, in 5/7 nights over the last month

You identify as either African American/Black or Caucasian American/White.

Exclusion Criteria

You have a high risk for a condition called obstructive sleep apnea, which affects your breathing while you sleep.

You have a very high body weight for your height.

You have a medical or mental health condition that affects your sleep or heart health, such as diagnosed heart problems, high blood pressure, depression, bipolar disorder, or post-traumatic stress disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Night

Participants complete low arousal tasks prior to bedtime in the sleep laboratory

1 night

1 visit (in-person)

Social Rejection Night

Participants are exposed to a social rejection paradigm prior to bedtime in the sleep laboratory

1 night

1 visit (in-person)

Follow-up

Participants are monitored for changes in sleep and cardiovascular outcomes after the experimental nights

1-2 weeks

Treatment Details

Interventions

• Social rejection

Trial Overview The trial examines how race-based social rejection affects sleep quality and nighttime heart function in African Americans and Caucasians. It compares the effects of a socially rejecting experience against a control non-rejection scenario during two different nights in a sleep lab.

Participant Groups

Group I: Social rejection by out-group Experimental Treatment 1 Intervention

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).

Group II: Social rejection by in-group Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep, emotional supportiveness, and socially straining behavior: A multidimensional approach. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Social support from the closest person and sleep quality in later life: Evidence from a British birth cohort study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Bidirectional Links Between Social Rejection and Sleep. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of individualized social activity on sleep in nursing home residents with dementia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of young children's bedtime refusal and nighttime wakings: a comparison of "standard" and graduated ignoring procedures. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Measuring online and offline social rejection sensitivity in the digital age. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Abnormal emotional and neural responses to romantic rejection and acceptance in depressed women. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Rejection sensitivity and children's interpersonal difficulties. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Age Differences in Reactions to Social Rejection: The Role of Cognitive Resources and Appraisals. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Anxious solitude and peer exclusion predict social helplessness, upset affect, and vagal regulation in response to behavioral rejection by a friend. [2021]