NCT05656768

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,427

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jun 2023Dec 2028

First Submitted

Initial submission to the registry

November 18, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

5.6 years

First QC Date

November 18, 2022

Last Update Submit

January 27, 2026

Conditions

SleepCircadian RhythmBlood PressureHypertension

Keywords

sleepcircadian rhythmcircadian misalignmentnocturnal hypertensionnon-dipping blood pressure

Outcome Measures

Primary Outcomes (2)

  • Change in Melatonin

    Melatonin levels obtained from saliva samples

    Hourly samples obtained over 30 hours

  • Change in Core body temperature

    Core body temperature

    Continuous measurements over 30 hours

Secondary Outcomes (1)

  • Change in Blood pressure

    Measurements obtained every 30 minutes over 30 hours

Study Arms (1)

Constant Routine Protocol

EXPERIMENTAL

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

Interventions

Constant Routine ProtocolOTHER

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.

Constant Routine Protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant in the parent grant (IDH-MEGA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0017, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Stephen J Thomas, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 19, 2022

Study Start

June 1, 2023

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

US(1)