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CPAP for the Treatment of Supine Hypertension

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 days
  • Procedures mentioned: Physical exams, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study includes up to 5 days spent in the Vanderbilt University Medical Center, at least one day of screening tests, followed by 2 study days and/or 2 study nights."
  • "Screening tests include a physical examination and history, routine safety laboratory assessments, and autonomic nervous system testing."
  • "A saline lock or IV catheter will be inserted in one of the arm's veins for blood sample collection."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether CPAP can lower high blood pressure at night while lying down. CPAP uses a machine and mask to gently push air into the airways. The study is for adults ages 40–80 with autonomic failure, a condition that affects nerves controlling blood pressure and other body functions.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40–80 with autonomic failure, including pure autonomic failure, multiple system atrophy, or Parkinson disease.
  • Have a nerve-related drop in blood pressure when standing: the top number falls at least 20 points within 3 minutes. Nerve tests must confirm the problem, with no other cause found.
  • Have high blood pressure while lying down at night: the top number is at least 140 during overnight screening.
  • Are willing and able to give informed consent, meaning you understand and agree to join the study.

Who can't join

  • Have had a recent face injury or surgery, or cannot tolerate CPAP or its mask.
  • Cannot safely stop study-related medicines: after stopping, you cannot stand for at least 1 minute or your blood pressure stays at 180/110 or higher while lying down.
  • Are confined to bed or cannot stand because of movement problems or a severe blood pressure drop when standing.
  • Smoke or are pregnant.
  • Have unstable disease in the blood vessels supplying the heart, or had a major heart, blood vessel, brain, or nerve event in the past 6 months.
  • Have heart failure.
  • Have other problems, including important abnormal exam or lab results, that the study doctor believes would keep you from completing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 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 ≥140 mmHg) during the overnight screening for supine hypertension. * Patients who are willing and able to provide informed consent Exclusion Criteria: * Patients with history of recent facial trauma or surgery or intolerance to CPAP or to the CPAP mask. * Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute or those with sustained supine blood pressure ≥180/110 mmHg after the medication withdrawal period. * Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension. * Smokers, patients who are pregnant, or have clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months; heart failure; and other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical or laboratory testing.

Study sites (1)

TN