CPAP for the Treatment of Supine Hypertension

NCT05489575 | Recruiting FDA Device

• 3 other identifiers: 220821R01HL161095200124
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Failure; Pure Autonomic Failure; Multiple System Atrophy; Parkinson Disease; Supine Hypertension; Neurogenic Orthostatic Hypotension

Keywords

CPAP; Hypertension; Orthostatic hypotension

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• 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

Study Arms (5)

Active CPAP (Daytime Study)

EXPERIMENTAL

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

Device: Active CPAP

Sham CPAP (Daytime Study)

SHAM COMPARATOR

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

Device: Sham CPAP

Active CPAP (Overnight Study)

EXPERIMENTAL

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

Device: Active CPAP

Sham CPAP (Overnight Study)

SHAM COMPARATOR

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

Device: Sham CPAP

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

ACTIVE COMPARATOR

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

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

Interventions

Active CPAP DEVICE

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

Also known as: Active continuous positive airway pressure

Active CPAP (Daytime Study); Active CPAP (Overnight Study)

Sham CPAP DEVICE

Sham continuous positive airway pressure applied at \<4 cm H2O

Also known as: Sham continuous positive airway pressure

Sham CPAP (Daytime Study); Sham CPAP (Overnight Study)

Sleeping in a head-up tilt (HUT) position OTHER

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

Also known as: HUT sleeping

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Pure Autonomic Failure; Multiple System Atrophy; Parkinson Disease; Hypertension; Hypotension, Orthostatic

Interventions

Sleep; Patient Positioning

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Vascular Diseases; Cardiovascular Diseases; Orthostatic Intolerance; Hypotension

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bonnie K Black, RN, NP

CONTACT

615-343-6862; bonnie.black@vumc.org

Luis E Okamoto, MD

CONTACT

615-936-6119; luis.e.okamoto@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A sham CPAP will be used.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Model Details: Randomized, single-blind, crossover

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 5, 2022
• Study Start: June 23, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)