CPAP for the Treatment of Supine Hypertension

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

Sponsors

Lead Sponsor: Vanderbilt University Medical Center

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Source Vanderbilt University Medical Center
Brief 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.

Detailed 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.

Overall Status Recruiting
Start Date 2022-06-23
Completion Date 2026-08-31
Primary Completion Date 2026-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Systolic blood pressure (daytime) day 1 and 2 (within 2 hours of the intervention)
Systolic blood pressure (overnight) up to 9 hours during the intervention
Secondary Outcome
Measure Time Frame
Stroke Volume (daytime) day 1 and 2 (within 2 hours of the intervention)
Natriuretic hormone (daytime) day 1 and 2 (within 2 hours of the intervention)
Nocturnal diuresis (overnight) up to 9 hours during the intervention
Morning orthostatic tolerance (overnight) during 10 minutes upright tilt
Enrollment 59
Condition
Intervention

Intervention Type: Device

Intervention Name: Active CPAP

Description: 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

Other Name: Active continuous positive airway pressure

Intervention Type: Device

Intervention Name: Sham CPAP

Description: Sham continuous positive airway pressure applied at <4 cm H2O

Other Name: Sham continuous positive airway pressure

Intervention Type: Other

Intervention Name: Sleeping in a head-up tilt (HUT) position

Description: Sleeping with the whole bed tilted head-up by 10 degrees or with the head elevated by 13-14 inches.

Arm Group Label: Sleeping in a head-up tilt position (Overnight Study)

Other Name: HUT sleeping

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.

Gender:

All

Minimum Age:

40 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Italo Biaggioni, MD Principal Investigator Vanderbilt University Medical Center
Overall Contact

Last Name: Bonnie K Black, RN, NP

Phone: 615-343-6862

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Autonomic Dysfunction Center/ Vanderbilt University Medical Center Bonnie K Black, RN, NP 615-343-6862 [email protected] Andre Diedrich, MD, PhD Sub-Investigator Alfredo Gamboa, MD Sub-Investigator Cyndya A Shibao, MD Sub-Investigator Italo Biaggioni, MD Principal Investigator Luis E Okamoto, MD Principal Investigator
Location Countries

United States

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Vanderbilt University Medical Center

Investigator Full Name: Italo Biaggioni

Investigator Title: Professor of Medicine and Pharmacology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Active CPAP (Daytime Study)

Type: Experimental

Description: CPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake.

Label: Sham CPAP (Daytime Study)

Type: Sham Comparator

Description: Sham CPAP is applied for up to 2 hours while supine and awake.

Label: Active CPAP (Overnight Study)

Type: Experimental

Description: CPAP at 8, 10, or 12 cm H2O is applied for up to 9 hours during the night.

Label: Sham CPAP (Overnight Study)

Type: Sham Comparator

Description: Sham CPAP is applied for up to 9 hours during the night.

Label: Sleeping in a head-up tilt position (Overnight Study)

Type: Active Comparator

Description: Sleeping with the bed tilted head-up by 10 degrees for up to 9 hours during the night.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Randomized, single-blind, crossover

Primary Purpose: Treatment

Masking: Single (Participant)

Masking Description: A sham CPAP will be used.

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