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CPAP for the Treatment of Supine Hypertension

NCT05489575 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-04-07

No results posted yet for this study

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

Interventions

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

DEVICE

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Italo Biaggioni, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2027-03-01
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489575 on ClinicalTrials.gov