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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 weeks
Treatment ~ Varies
Follow Up ~baseline to post-rejection task, anticipated average of 42 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-rejection task, anticipated average of 42 minutes for reporting.

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 more

Awards & 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
~470

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,586 Previous Clinical Trials
14,899,987 Total Patients Enrolled
6 Trials studying Sleep
440 Patients Enrolled for Sleep
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,934 Previous Clinical Trials
47,792,199 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

Sleep Restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166590 — N/A
~17 spots leftby Dec 2025
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