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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
SASE Trial 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.Check my eligibility
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.See study design
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.
SASE Trial 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 the two nights will occur 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 the two nights will occur consecutively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in sleep onset latency, as determined by polysomnography
Secondary outcome measures
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 moreSASE 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
2,503 Previous Clinical Trials
15,236,516 Total Patients Enrolled
6 Trials studying Sleep
378 Patients Enrolled for Sleep
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,496 Total Patients Enrolled
31 Trials studying Sleep
56,934 Patients Enrolled for Sleep
Aric A Prather, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
1,535 Total Patients Enrolled
1 Trials studying Sleep
77 Patients Enrolled for Sleep
Media Library
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.
Sleep Patient Testimony for trial: Trial Name: NCT03937973 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment ongoing for this research protocol?
"According to the data posted on clinicaltrials.gov, this investigation is currently searching for participants. Initially made public on April 9th of 2019, its most recent update was July 28th 2022."
Answered by AI
What is the enrollment capacity of this experiment?
"Affirmative. The information posted on clinicaltrials.gov states that this research is presently enrolling participants, having been first advertised in April of 2019 and most recently modified on July 28th 2022. 160 people are needed across 1 medical centre for the study to be successful."
Answered by AI
Does this research include individuals over the age of 40?
"This clinical trial's acceptability parameters specify that the age cutoff for applicants is 18 to 64. Conversely, 36 studies are available for minors and 168 options exist for seniors aged 65 or older."
Answered by AI
Who meets the qualifications to participate in this trial?
"The criteria to enter this clinical trial are rigorous and limited. To be eligible, applicants must identify as either African American/Black or Caucasian American/White; they should have a regular bedtime between 10PM and 12AM for the past 3 months (verified by diary entries); additionally, sleep duration over 5 nights in the last month has to fall within 6.5-8.5 hours range (also validated through wrist actigraphy). The age restriction is quite clear: 18-64 years old only."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
University of California, San Francisco
Why did patients apply to this trial?
Help & make $. I'm eager to help others, plus I could really use the money right now.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How responsive is this trial?
Most responsive sites:
- University of California, San Francisco: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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