Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT05489575

CPAP for the Treatment of Supine Hypertension

Led by Vanderbilt University Medical Center · Updated on 2026-04-07

59

Participants Needed

1

Research Sites

270 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

This study aims to learn about the effects of continuous positive airway pressure (CPAP) on people with autonomic failure and high blood pressure when lying down (supine hypertension) to determine if it can be used to treat their high blood pressure during the night. CPAP (a widely used treatment for sleep apnea) involves using a machine that blows air into a tube connected to a mask covering the nose, or nose and mouth, to apply a low air pressure in the airways. The study includes 3-5 days spent in the Vanderbilt Clinical Research Center (CRC): at least one day of screening tests, followed by up to 3 study days. Subjects may be able to participate in daytime and/or overnight studies. The Daytime study consists of 2 study days: one with active CPAP and one with sham CPAP applied for up to 2 hours. The Overnight study consists of 3 study nights: one with active CPAP, one with sham CPAP, both applied for up to 9 hours and one night sleeping with the bed tilted head-up.

CONDITIONS

Official Title

CPAP for the Treatment of Supine Hypertension

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

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 �3E=20-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
  • Nocturnal supine hypertension (nighttime systolic blood pressure �3E=140 mmHg) during the overnight screening for supine hypertension.
  • Patients who are willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • History of recent facial trauma or surgery or intolerance to CPAP or to the CPAP mask.
  • Patients who cannot tolerate medication withdrawal, defined as inability to stand at least one minute or sustained supine blood pressure �3E=180/110 mmHg after medication withdrawal.
  • Bedridden patients or those unable to stand due to motor impairment or severe orthostatic hypotension.
  • Smokers, pregnant patients, or those with unstable coronary artery disease, major cardiovascular or neurological events in past 6 months, heart failure, or clinically significant abnormalities preventing protocol completion.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

B

Bonnie K Black, RN, NP

CONTACT

L

Luis E Okamoto, MD

CONTACT

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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