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CPAP for the Treatment of Supine Hypertension

RecruitingNAAges 40 Years - 80 YearsAllVanderbilt University Medical Center
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In plain words

What the trial is, and whether it could suit you

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,

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ20-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 โ‰ฅ140 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 โ‰ฅ180/110 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.
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What it tests

  • Active CPAP
  • Sham CPAP
  • Sleeping in a head-up tilt (HUT) position
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Where

1 site
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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