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Sleep and Circadian Contributions to Nighttime Blood Pressure (SCN-BP)

Primary Purpose

Sleep, Circadian Rhythm, Blood Pressure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Constant Routine Protocol
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep focused on measuring sleep, circadian rhythm, circadian misalignment, nocturnal hypertension, non-dipping blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participant in the parent grant (IDH-MEGA) Exclusion Criteria: -

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Constant Routine Protocol

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Melatonin
Melatonin levels obtained from saliva samples
Change in Core body temperature
Core body temperature

Secondary Outcome Measures

Change in Blood pressure
Systolic and diastolic blood pressure obtained using an ambulatory blood pressure monitor

Full Information

First Posted
November 18, 2022
Last Updated
June 22, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05656768
Brief Title
Sleep and Circadian Contributions to Nighttime Blood Pressure
Acronym
SCN-BP
Official Title
Sleep and Circadian Contributions to Nighttime Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 30, 2028 (Anticipated)
Study Completion Date
December 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Circadian Rhythm, Blood Pressure, Hypertension
Keywords
sleep, circadian rhythm, circadian misalignment, nocturnal hypertension, non-dipping blood pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Constant Routine Protocol
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Constant Routine Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Melatonin
Description
Melatonin levels obtained from saliva samples
Time Frame
Hourly samples obtained over 30 hours
Title
Change in Core body temperature
Description
Core body temperature
Time Frame
Continuous measurements over 30 hours
Secondary Outcome Measure Information:
Title
Change in Blood pressure
Description
Systolic and diastolic blood pressure obtained using an ambulatory blood pressure monitor
Time Frame
Measurements obtained every 30 minutes over 30 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant in the parent grant (IDH-MEGA) Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Thomas, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0017
Country
United States

12. IPD Sharing Statement

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Sleep and Circadian Contributions to Nighttime Blood Pressure

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