Sleep and Circadian Contributions to Nighttime Blood Pressure

Not Applicable

• Conditions: Hypertension; Sleep; Blood Pressure; Circadian Rhythm
• Interventions: Other: Constant Routine Protocol

• Registration Number: NCT05656768
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-19
• Study Start: 2023-06-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2028-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Participant in the parent grant (IDH-MEGA)

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Constant Routine Protocol	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.

Primary Outcome Measures

Name	Time	Method
Change in Melatonin	Hourly samples obtained over 30 hours	Melatonin levels obtained from saliva samples
Change in Core body temperature	Continuous measurements over 30 hours	Core body temperature

Secondary Outcome Measures

Name	Time	Method
Change in Blood pressure	Measurements obtained every 30 minutes over 30 hours	Systolic and diastolic blood pressure obtained using an ambulatory blood pressure monitor

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States