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Sleep Restriction for High Blood Pressure (SASE2 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 baseline to post-rejection task, anticipated average of 42 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial will test how sleep deprivation affects a person's ability to discriminate, as well as their cardiovascular health. The study will specifically focus on African Americans to see how they are affected.
Who is the study for?
This study is for English-speaking African Americans aged 18-64 who usually sleep between 10 PM and 12 AM, with a normal sleep duration of 6.5 to 8.5 hours confirmed by actigraphy and diary. Excluded are those over age 64, BMI of 40+, with clinical sleep disorders or on medications affecting sleep/cardiovascular function.
What is being tested?
The trial examines how restricted sleep affects perceptions of discrimination and cardiovascular health in African Americans. It will also explore factors that might influence the link between racial discrimination experiences and actual sleep patterns.
What are the potential side effects?
Since this trial involves sleep restriction, potential side effects may include increased fatigue, irritability, difficulty concentrating, mood changes, and possibly elevated blood pressure due to stress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to post-rejection task, anticipated average of 42 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to post-rejection task, anticipated average of 42 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in blood pressure post-rejection
Secondary study objectives
Change in affect
Change in heart rate variability (HRV) in response to rejection task
Change in pre-ejection period (PEP) in response to rejection task
+2 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
Active Control
Group I: Total Sleep RestrictionExperimental Treatment1 Intervention
Participants will experience a night of total sleep restriction and then undergo a social-rejection task in the morning.
Group II: Normal SleepActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Restriction
2016
N/A
~490
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,873 Total Patients Enrolled
6 Trials studying Sleep
440 Patients Enrolled for Sleep
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,822 Total Patients Enrolled
33 Trials studying Sleep
57,079 Patients Enrolled for Sleep
Aric A Prather, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
1,597 Total Patients Enrolled
1 Trials studying Sleep
139 Patients Enrolled for Sleep
Media Library
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.