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Clinical Trials/NCT05656768
NCT05656768
Enrolling By Invitation
Not Applicable

Sleep and Circadian Contributions to Nighttime Blood Pressure

University of Alabama at Birmingham1 site in 1 country1,427 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Constant Routine Protocol
Conditions
Sleep
Sponsor
University of Alabama at Birmingham
Enrollment
1427
Locations
1
Primary Endpoint
Change in Melatonin
Status
Enrolling By Invitation
Last Updated
3 months ago

Overview

Brief Summary

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

Detailed 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. Aims 1 and 2 are purely observation. The study design design described below pertains the intervention piece of this study (Aim 3).

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
December 30, 2028
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Justin Thomas, PhD

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Participant in the parent grant (IDH-MEGA)

Exclusion Criteria

  • Not provided

Arms & Interventions

Constant Routine Protocol

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.

Intervention: Constant Routine Protocol

Outcomes

Primary Outcomes

Change in Melatonin

Time Frame: Hourly samples obtained over 30 hours

Melatonin levels obtained from saliva samples

Change in Core body temperature

Time Frame: Continuous measurements over 30 hours

Core body temperature

Secondary Outcomes

  • Change in Blood pressure(Measurements obtained every 30 minutes over 30 hours)

Study Sites (1)

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