Sleep and Circadian Contributions to Nighttime Blood Pressure
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT05656768
- Status
- Enrolling By Invitation
Conditions
- Blood Pressure
- Circadian Rhythm
- Hypertension
- Sleep
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Constant Routine Protocol — OTHERA 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.
Study Details
Broadly, this study (SCN-BP) seeks to examine sleep and circadian factors that contribute to blood pressure levels at night.
Key Dates
- Start date
- Jun 1, 2023
- Status verified
- Jan 2026
- Primary completion
- Dec 30, 2028
- Completion
- Dec 30, 2028
Study Design
- Enrollment
- 1,427 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Constant Routine ProtocolParticipants 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.
Primary Outcome Measure
Change in Melatonin [ Time Frame: Hourly samples obtained over 30 hours ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0017 | - |
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