ClinicalTrials.gov record NCT03312556

Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old to 85 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized crossover study compares nighttime continuous positive airway pressure (CPAP) with placebo or sham in people who have autonomic failure and supine hypertension. The study first tests CPAP at several short pressure levels and may use a tolerable pressure overnight if a blood-pressure response is seen. Main measurements include change in supine systolic blood pressure and nighttime urine volume.

What it is studying. The study tests whether CPAP has an acute blood-pressure–lowering effect in patients with autonomic failure who have supine hypertension. During an initial CPAP trial, pressure is applied sequentially at 0, 4, 8, 12 and 16 cm H2O for short periods (1–20 minutes each) to assess blood-pressure response and tolerability; if a pressure level both lowers blood pressure and is tolerated, that level may be applied during the night.

What the researchers hope to learn. To learn whether CPAP can lower supine systolic blood pressure in patients with autonomic failure and supine hypertension and to measure effects on nocturnal urine volume. The study aims to define whether CPAP produces an acute blood-pressure change and to inform future treatment research.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Placebo
Device
  • continuous positive airway pressure (CPAP)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. This study will test the hypothesis that continuous positive airway pressure (CPAP) has an acute lowering-BP effect in autonomic failure patients with supine hypertension. CPAP is a widely-used treatment for sleep-related breathing disorders including sleep apnea, that uses mild air pressure to keep the breathing airways open. It involves using a CPAP machine that blows air into a tube connected to a mask placed over the nose, or nose and mouth. For these studies, a commercial CPAP device will be used to apply pressure sequentially at 0, 4, 8, 12 and 16 cm H2O for 1-20 minute each. Depending on the BP response and tolerability to CPAP, CPAP may be applied during the night using a CPAP level that was tolerable and showed a BP-lowering effect during the acute test.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will undergo an acute CPAP test where pressure is applied in steps (0, 4, 8, 12 and 16 cm H2O) for short periods (1–20 minutes each) to see the blood-pressure response and tolerability. The study uses a randomized crossover approach: participants will have periods with night-time CPAP (device starting at 20:00 at a tolerated level determined in the test) and periods with placebo pill/patch or a sham CPAP. Blood pressure will be monitored (supine blood pressure change over a 12-hour period is a main measure) and nocturnal urine volume will be recorded. Participation involves wearing a CPAP mask and device during the night when CPAP is used, and likely short clinic visits for the acute test and monitoring.

How the study is structured. Interventional, randomized crossover study with no masking. Participants undergo an acute CPAP pressure trial and are assigned in different periods to CPAP (overnight use at a tolerated level) or to placebo pill/patch or sham CPAP. Primary outcome is change in supine systolic blood pressure measured over a 12-hour timeframe; a secondary outcome is nocturnal urinary volume.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Sep 21, 2017
Primary completion
Sep 21, 2026 (estimated)
Study completion
Dec 21, 2026 (estimated)
Target enrollment
12 participants (estimated)
Last updated on registry
Nov 6, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Vanderbilt University Medical Center
Principal investigator
Italo Biaggioni, Professor of Medicine and Pharmacology
Vanderbilt University Medical Center

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Autonomic Dysfunction Center/ Vanderbilt University Medical CenterRecruiting

    Nashville, Tennessee, 37232 · United States

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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