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Social Rejection for Sleep (SASE Trial)
N/A
Waitlist Available
Led By Aric A Prather, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare how well 80 African Americans and 80 Caucasian Americans sleep after being rejected based on their race.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this study involves psychological interventions rather than medication, side effects may include temporary feelings of distress or discomfort due to the social rejection simulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in sleep onset latency, as determined by polysomnography
Secondary study objectives
Change in heart rate variability (HRV) in response to rejection task
Change in minutes of wake after sleep onset (WASO), as determined by polysomnography
Heart rate
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Social rejection by out-groupExperimental Treatment1 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-groupExperimental Treatment1 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).
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,586 Previous Clinical Trials
14,899,837 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,182 Total Patients Enrolled
Aric A Prather, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
1,535 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The required age range for this survey is 18 to 64 years old.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 monthYou have a high risk for a condition called obstructive sleep apnea, which affects your breathing while you sleep.You identify as either African American/Black or Caucasian American/White.You usually go to bed between 10 PM and 12 AM for at least 5 nights out of the week for the past 3 months. We will confirm this information by asking you to keep a sleep diary and wear a wrist device that tracks your sleep patterns.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.You are taking medications that can disrupt sleep or affect your heart, such as antidepressants, anti-anxiety drugs, sleep aids, or beta-blockers.
Research Study Groups:
This trial has the following groups:- Group 1: Social rejection by in-group
- Group 2: Social rejection by out-group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Blood Pressure Patient Testimony for trial: Trial Name: NCT03937973 — N/A
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