SCN-BP: Sleep and Circadian Contributions to Nighttime Blood Pressure

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05656768
• Collaborator: (none)
• Enrollment: 70
• Arm: 1
• Anticipated Duration (Months): 72

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep; Circadian Rhythm; Blood Pressure; Hypertension	Other: Constant Routine Protocol	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Sleep and Circadian Contributions to Nighttime Blood Pressure
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 30, 2028
• Anticipated Study Completion Date: Dec 30, 2028

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

1. Change in Melatonin [Hourly samples obtained over 30 hours]

   Melatonin levels obtained from saliva samples

2. Change in Core body temperature [Continuous measurements over 30 hours]

   Core body temperature

Secondary Outcome Measures

1. Change in Blood pressure [Measurements obtained every 30 minutes over 30 hours]

   Systolic and diastolic blood pressure obtained using an ambulatory blood pressure monitor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participant in the parent grant (IDH-MEGA)

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Stephen J Thomas, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephen Justin Thomas, PhD, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT05656768
• Other Study ID Numbers: IRB-300010042
• First Posted: Dec 19, 2022
• Last Update Posted: Dec 19, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stephen Justin Thomas, PhD, Assistant Professor, University of Alabama at Birmingham: sleep; circadian rhythm; circadian misalignment; nocturnal hypertension; non-dipping blood pressure
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Dec 19, 2022