CPAP for High Blood Pressure with Autonomic Failure

This study is investigating if Continuous Positive Airway Pressure (CPAP) can help treat high blood pressure that occurs when lying down (supine hypertension) in people with autonomic failure (a condition where the nervous system doesn't control body functions well). CPAP is a device that delivers air pressure through a mask. Researchers want to see if CPAP, compared to a sham (inactive) CPAP or sleeping with your head elevated, can lower your blood pressure during the day and overnight. The study aims to enroll 59 participants, aged 40-80, who have autonomic failure due to conditions like Parkinson's disease. Success will be measured by changes in your systolic blood pressure (the top number in a blood pressure reading) during the day and overnight. The current recruitment status is unclear.

Study design
This is an interventional study comparing active CPAP, sham CPAP, and sleeping in a head-up tilt position. It plans to enroll 59 participants.
What's involved
You would spend 3-5 days at the Vanderbilt Clinical Research Center, including screening tests and up to three study days/nights. This involves physical exams, blood and urine samples, and wearing a CPAP mask.
Compensation
Not stated in the trial record.
Follow-up
Blood pressure will be measured on day 1 and 2 (within 2 hours of intervention) for daytime studies, and up to 9 hours during overnight interventions.

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NCT05489575

CPAP for the Treatment of Supine Hypertension

Recruiting
NAAges 40–80InterventionalTreatment
Vanderbilt University Medical Center
~59 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Active CPAPSham CPAPSleeping in a head-up tilt (HUT) position

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Systolic blood pressure (daytime)
Measured over day 1 and 2 (within 2 hours of the intervention)
+1 more outcome measured
Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy
Parkinson Disease
Supine Hypertension
Neurogenic Orthostatic Hypotension
1 sites across 1 states
Tennessee1
  • Italo Biaggioni, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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Eligibility criteria

Inclusion

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

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.
  • Systolic blood pressure (daytime)day 1 and 2 (within 2 hours of the intervention)

    Change from baseline in systolic blood pressure at 2 hours of the intervention

  • Systolic blood pressure (overnight)up to 9 hours during the intervention

    Area under the curve of the change from baseline in systolic blood pressure