Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Tennessee
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Bonnie K Black, RN, NP
bonnie.black@vumc.org
615-343-6862
Backup
Luis E Okamoto, MD
luis.e.okamoto@vumc.org
615-936-6119
Time Frame
Start Date: 2022-06-23
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 59
Treatments
Experimental: Active CPAP (Daytime Study)
CPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake.
Sham_comparator: Sham CPAP (Daytime Study)
Sham CPAP is applied for up to 2 hours while supine and awake.
Experimental: Active CPAP (Overnight Study)
CPAP at 8, 10, or 12 cm H2O is applied for up to 9 hours during the night.
Sham_comparator: Sham CPAP (Overnight Study)
Sham CPAP is applied for up to 9 hours during the night.
Active_comparator: Sleeping in a head-up tilt position (Overnight Study)
Sleeping with the bed tilted head-up by 10 degrees for up to 9 hours during the night.
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov