Sleep and Circadian Contributions to Nighttime Blood Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Constant Routine Protocol.
- Who it may be relevant to
- Registry conditions: Sleep, Circadian Rhythm, Blood Pressure, Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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. Aims 1 and 2 are purely observation. The study design design described below pertains the intervention piece of this study (Aim 3).
Interventions
- 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.
Primary outcome measures
- Change in Melatonin [Time frame: Hourly samples obtained over 30 hours]
- Change in Core body temperature [Time frame: Continuous measurements over 30 hours]
Secondary outcome measures (1)
- Change in Blood pressure [Time frame: Measurements obtained every 30 minutes over 30 hours]
Eligibility criteria
Inclusion criteria
- Participant in the parent grant (IDH-MEGA)
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT05656768 · IRB-300010042