CPAP for the Treatment of Supine Hypertension

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Aug 3, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a treatment called continuous positive airway pressure (CPAP) for people who have high blood pressure when lying down, known as supine hypertension. This condition often affects individuals with autonomic failure, which can occur in diseases like Parkinson's and multiple system atrophy. The goal is to see if using CPAP at night can help lower their blood pressure while they sleep. CPAP works by blowing air into a mask that keeps the airways open, and it's commonly used for treating sleep apnea.

To participate in this study, individuals should be between 40 and 80 years old and have a diagnosis of autonomic failure with specific blood pressure issues. Participants will spend 3 to 5 days at the Vanderbilt Clinical Research Center, where they will go through screening tests and then take part in daytime and overnight studies to see how effective CPAP is. During these studies, some will use active CPAP while others may use a placebo (a device that looks like CPAP but doesn't actually provide air) for comparison. It's important to note that not everyone will qualify, as certain health conditions or recent surgeries may exclude potential participants.

Gender

ALL

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.