CPAP for the Treatment of Supine Hypertension
Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy
About this trial
This is an interventional treatment trial for Autonomic Failure focused on measuring CPAP, Hypertension, Orthostatic hypotension
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.
Sites / Locations
- Autonomic Dysfunction Center/ Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Sham Comparator
Experimental
Sham Comparator
Active Comparator
Active CPAP (Daytime Study)
Sham CPAP (Daytime Study)
Active CPAP (Overnight Study)
Sham CPAP (Overnight Study)
Sleeping in a head-up tilt position (Overnight Study)
CPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake.
Sham CPAP is applied for up to 2 hours while supine and awake.
CPAP at 8, 10, or 12 cm H2O is applied for up to 9 hours during the night.
Sham CPAP is applied for up to 9 hours during the night.
Sleeping with the bed tilted head-up by 10 degrees for up to 9 hours during the night.