CPAP for the Treatment of Supine Hypertension

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489575
• Other study ID #: 220821
• Secondary ID: R01HL16109520012
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Bonnie K Black, RN, NP
• Phone: 615-343-6862
• Email: bonnie.black[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study includes up to 5 days spent in the Vanderbilt University Medical Center, at least one day of screening tests, followed by 2 study days and/or 2 study nights. Screening tests include a physical examination and history, routine safety laboratory assessments, and autonomic nervous system testing. Medications for high blood pressure will be held for at least 5 half-lives before studies. Subjects may be able to participate in the daytime and/or the overnight studies. Daytime Study: Eligible participants will be studied on two separate days in random order: one day with a high CPAP level and one day with a low CPAP level. The active CPAP level will be determined during a CPAP titration trial On each study day, participants will be instrumented to measure blood pressure, heart rate, hemodynamic parameters, segmental impedance, and markers of cardiovascular risk. A saline lock or IV catheter will be inserted in one of the arm's veins for blood sample collection. Urine will also be collected during studies. After baseline measurements, active or sham CPAP will then be applied for up to 2 hours. Outcome measurements will be repeated after 1 and 2 hours of CPAP. Overnight Studies: Eligible participants will be studied on three separate nights in random order with a active CPAP, sham CPAP, and sleeping in a head-up tilt position. The active CPAP level will be determined during a CPAP titration trial. On each study night, the intervention (active CPAP, sham CPAP, or head-up tilt position) will be applied for up to 9 hours. Blood pressure, heart rate, hemodynamic parameters, and markers of cardiovascular risk will be assessed throughout the night. Urine will also be collected during this period. On the following morning, participants will have a tilt table test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: August 31, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Failure
• Hypertension
• Hypotension
• Hypotension, Orthostatic
• Multiple System Atrophy
• Neurogenic Orthostatic Hypotension
• Parkinson Disease
• Pure Autonomic Failure
• Shy-Drager Syndrome
• Supine Hypertension

Intervention

Device:
• Active CPAP
Continuous positive airway pressure (CPAP) is applied at 8, 10, or 12 cm H20. The active CPAP level will be determined during a CPAP titration trial
• Sham CPAP
Sham continuous positive airway pressure applied at <4 cm H2O

Other:
• Sleeping in a head-up tilt (HUT) position
Sleeping with the whole bed tilted head-up by 10 degrees or with the head elevated by 13-14 inches.

Locations

Country	Name	City	State
United States	Autonomic Dysfunction Center/ Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure (daytime)	Change from baseline in systolic blood pressure at 2 hours of the intervention	day 1 and 2 (within 2 hours of the intervention)
Primary	Systolic blood pressure (overnight)	Area under the curve of the change from baseline in systolic blood pressure	up to 9 hours during the intervention
Secondary	Stroke Volume (daytime)	Change from baseline in stroke volume at 1and 2 hours of the intervention	day 1 and 2 (within 2 hours of the intervention)
Secondary	Natriuretic hormone (daytime)	Percent change from baseline in N-terminal-proatrial natriuretic peptide at 2 hours after the intervention	day 1 and 2 (within 2 hours of the intervention)
Secondary	Nocturnal diuresis (overnight)	Urine volume collected during the night	up to 9 hours during the intervention
Secondary	Morning orthostatic tolerance (overnight)	Area under the curve of the upright systolic blood pressure during head-up tilt	during 10 minutes upright tilt