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Behavioural Intervention
Sleep and Circadian Rhythm Study for High Blood Pressure (SCN-BP Trial)
N/A
Waitlist Available
Led By Stephen J Thomas, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Participant in the parent grant (IDH-MEGA)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurements obtained every 30 minutes over 30 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how sleep and body clock affect nighttime blood pressure.
Who is the study for?
This trial is for participants of the parent grant IDH-MEGA who are interested in understanding how sleep and their body's internal clock affect nighttime blood pressure.
What is being tested?
The study is exploring how sleep patterns and circadian rhythms influence high blood pressure at night using a Constant Routine Protocol to monitor changes.
What are the potential side effects?
Since this trial involves monitoring rather than medication, side effects are minimal but may include discomfort from wearing monitoring equipment or disruption of normal sleep patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measurements obtained every 30 minutes over 30 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurements obtained every 30 minutes over 30 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Core body temperature
Change in Melatonin
Secondary study objectives
Change in Blood pressure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Constant Routine ProtocolExperimental Treatment1 Intervention
Participants complete a 30-hour constant routine protocol to directly examine markers of endogenous circadian rhythms. In a constant routine protocol, participants remain in a dimly lit room (\<10 lux), in a semi-recumbent posture, remain awake, and consume iso-caloric snacks. Saliva samples are collected and core body temperature and blood pressure are measured.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,703 Total Patients Enrolled
1 Trials studying Sleep
87 Patients Enrolled for Sleep
Stephen J Thomas, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are already taking part in the main study called IDH-MEGA.
Research Study Groups:
This trial has the following groups:- Group 1: Constant Routine Protocol
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.
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