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Enrolling by Invitation

NCT Number: NCT05656768

Sleep and Circadian Contributions to Nighttime Blood Pressure

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

Enrolling by Invitation

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Key information

Conditions

Sleep Blood Pressure Cardiovascular Diseases Circadian Rhythm Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0017, United States

About this study

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. Aims 1 and 2 are purely observation. The study design design described below pertains the intervention piece of this study (Aim 3).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant in the parent grant (IDH-MEGA)

Exclusion criteria

-

Treatment and study plan

Constant Routine Protocol

Other

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 outcomes

  1. Change in Melatonin

    Time frame: Hourly samples obtained over 30 hours

    Melatonin levels obtained from saliva samples

  2. Change in Core body temperature

    Time frame: Continuous measurements over 30 hours

    Core body temperature

Secondary outcomes

  1. Change in Blood pressure

    Time frame: Measurements obtained every 30 minutes over 30 hours

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: SCN-BP

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2022
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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