Actively Recruiting
Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension
Led by Vanderbilt University Medical Center · Updated on 2026-04-07
59
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of continuous positive airway pressure (CPAP) on people aged 40 to 80 with autonomic failure and high blood pressure while lying down, known as supine hypertension. The goal is to see if CPAP, commonly used for sleep apnea, can treat high nighttime blood pressure in this group. The study is conducted at Vanderbilt University Medical Center and involves evaluating blood pressure and heart function under different conditions. The study includes up to 5 days at the research center, starting with screening tests like physical exams, lab tests, and autonomic nervous system evaluations. Participants may join daytime and/or overnight study phases. During the daytime study, they undergo two sessions with active CPAP or sham CPAP applied while awake for up to 2 hours. The overnight study involves three nights with active CPAP, sham CPAP, or sleeping with the bed tilted head-up, each for up to 9 hours. Active CPAP pressure levels are set during a prior titration trial. Participants will have blood pressure, heart rate, and other cardiovascular measures monitored during the interventions. Blood and urine samples will be collected, and a tilt table test will be done the morning after overnight studies. Researchers will assess changes in systolic blood pressure during the day and night, stroke volume, hormone levels, urine output, and orthostatic tolerance. The entire process includes careful monitoring and safety assessments, with study participation lasting up to 5 days.
CONDITIONS
Brief Title
CPAP for the Treatment of Supine Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy, and Parkinson disease.
- Neurogenic orthostatic hypotension, defined as a 20-mmHg or greater drop in systolic blood pressure within 3 minutes of standing with impaired autonomic reflexes.
- Nocturnal supine hypertension with nighttime systolic blood pressure of 140 mmHg or higher during screening.
- Willing and able to provide informed consent.
You will not qualify if you...
- History of recent facial trauma or surgery or intolerance to CPAP or the CPAP mask.
- Unable to tolerate medication withdrawal, including inability to stand for at least one minute or sustained supine blood pressure of 180/110 mmHg or higher after medication withdrawal.
- Bedridden or unable to stand due to motor impairment or severe orthostatic hypotension.
- Smokers, pregnant patients, or those with unstable coronary artery disease, recent major cardiovascular or neurological events within 6 months, heart failure, or other significant clinical or laboratory abnormalities preventing protocol completion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - At least 1 day
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for physical examination, history, safety labs, and autonomic testing
Duration - 2 days
Participants undergo two separate daytime study days in random order involving application of active or sham CPAP while supine and awake, with measurements taken before and during up to 2 hours of CPAP.
2 visits (in-person) for up to 2 hours each
Duration - 3 nights
Participants undergo three overnight study nights in random order with active CPAP, sham CPAP, and sleeping in a head-up tilt position, each lasting up to 9 hours with continuous monitoring and assessments.
3 overnight visits (in-person) with assessments during sleep and a morning tilt table test
Trial Site Locations
Total: 1 location
1
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
B
Bonnie K Black, RN, NP
L
Luis E Okamoto, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
5
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