RecruitingNot ApplicableNCT05489575

CPAP for the Treatment of Supine Hypertension

Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension


Sponsor

Vanderbilt University Medical Center

Enrollment

59 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether CPAP — the same type of breathing device used for sleep apnea — can help lower dangerously high blood pressure that occurs when people with certain nerve disorders lie down at night. People with conditions like Parkinson's disease or multiple system atrophy often have blood pressure that drops when they stand (causing dizziness) but spikes when they lie down at night, which is hard to treat. **You may be eligible if...** - You are between 40 and 80 years old - You have autonomic failure (a nerve disorder affecting blood pressure) such as pure autonomic failure, multiple system atrophy, or Parkinson's disease - You have low blood pressure when standing up (orthostatic hypotension) - Your blood pressure is too high when lying down at night (nighttime systolic BP above 140 mmHg) **You may NOT be eligible if...** - You have had recent facial trauma or surgery, or cannot tolerate wearing a CPAP mask - You are unable to stand for at least one minute after stopping blood pressure medications - You are bedridden or cannot stand due to severe motor problems - You are a smoker or pregnant - You have unstable coronary artery disease or other serious cardiovascular or neurological conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEActive CPAP

Continuous positive airway pressure (CPAP) is applied at 8, 10, or 12 cm H20. The active CPAP level will be determined during a CPAP titration trial

DEVICESham CPAP

Sham continuous positive airway pressure applied at \<4 cm H2O

OTHERSleeping in a head-up tilt (HUT) position

Sleeping with the whole bed tilted head-up by 10 degrees or with the head elevated by 13-14 inches.


Locations(1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05489575


Related Trials