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Recruiting NCT05489575

CPAP for the Treatment of Supine Hypertension

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Trial Parameters

Condition Autonomic Failure
Sponsor Vanderbilt University Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 59
Sex ALL
Min Age 40 Years
Max Age 80 Years
Start Date 2022-06-23
Completion 2027-03-01
Interventions
Active CPAPSham CPAPSleeping in a head-up tilt (HUT) position

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Brief 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 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 una

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