Recruiting

CPAP

Sponsor:

Vanderbilt University Medical Center

Code:

NCT03312556

Conditions

Supine Hypertension

Autonomic Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

continuous positive airway pressure (CPAP)

Placebo

Study Details

Brief summary:

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.

Conditions

Supine Hypertension

Autonomic Failure

Study ID

NCT03312556

Start date

Sep 21, 2017

Status verified date

Nov, 2025

Completion date

Dec 21, 2026

Anticipated

Primary completion date

Sep 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with autonomic failure and with supine hypertension from all races

Exclusion Criteria:

  • All medical students
  • Pregnant women
  • High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)
  • History of serious allergies or asthma.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo pill or patch or sham CPAP

Placebo pill or patch or sham CPAP

active comparator: CPAP (continuous positive airway pressure)

Continuous positive airway pressure during the night

Interventions

continuous positive airway pressure (CPAP)

Continuous positive airway pressure(CPAP) will be applied during the night starting from 20:00. CPAP level will be determined during an acute CPAP trial.

Placebo

Placebo pill or patch. Single dose

Primary outcome measure

  • Supine Systolic Blood Pressure [ Time Frame: 12 hours ]

Central Contacts and Locations

Central contacts

Bonnie K Black, RN

615-343-6862autonomics@vumc.org

Luis E Okamoto, MD

(615) 936-6119autonomics@vumc.org

Locations

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Emily C Smith, RN

615-875-1516autonomics@vumc.org

Bonnie K Black, RN

615-343-6862autonomics@vumc.org

Principal Investigator:

Italo Biaggioni, MD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Keywords

  • hypertension
  • supine hypertension
  • autonomic failure
  • pure autonomic failure
  • multiple system atrophy
  • cpap

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-11-06.