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NCT05656768 Clinical Trial

Sleep and Circadian Contributions to Nighttime Blood Pressure

Hypertension Clinical Trial

— SCN-BP  

Official title:
Sleep and Circadian Contributions to Nighttime Blood Pressure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05656768
Other study ID # IRB-300010042
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 30, 2028

Study information
Verified date June 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Broadly, this study (SCN-BP) seeks to examine sleep and circadian factors that contribute to blood pressure levels at night.

Description:

SCN-BP is imbedded in a parent grant titled "Improving the Detection of Hypertension (IDH-MEGA)" and examines a variety of sleep (e.g., sleep duration, timing, and the presence of sleep disorder) and circadian factors in Aims 1 and 2. In Aim 3, the investigators will conduct a 30-hour constant routine protocol to directly examine endogenous circadian and blood pressure rhythms.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 70
Est. completion date December 30, 2028
Est. primary completion date December 30, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participant in the parent grant (IDH-MEGA) Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Constant Routine Protocol
A constant routine protocol is used to directly examine markers of circadian rhythmicity (e.g., melatonin and core body temperature). A constant routine protocol requires an individual to remain in a dimly lit room, in a constant semi-recumbent posture, and remain awake for more than 24 hours. It is one of two gold-standard research protocols for examining circadian rhythms in humans.

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Melatonin Melatonin levels obtained from saliva samples Hourly samples obtained over 30 hours
Primary Change in Core body temperature Core body temperature Continuous measurements over 30 hours
Secondary Change in Blood pressure Systolic and diastolic blood pressure obtained using an ambulatory blood pressure monitor Measurements obtained every 30 minutes over 30 hours
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