Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID04502225

Impact of Decreased Venous Return on Supine Blood Pressure in Autonomic Failure

Led by Vanderbilt University Medical Center · Updated on 2025-11-06

44

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates supine hypertension, a condition where people with autonomic failure have high blood pressure while lying down. Autonomic failure causes issues like severe blood pressure drops upon standing, bladder and bowel problems, and sexual dysfunction. The study focuses on using gravity to reduce blood return to the heart by raising the head of the bed, aiming to lower blood pressure without medication and potentially improve related health risks. Participants will experience different ways of raising the head of the bed, either by tilting the whole bed or elevating just the trunk, with elevations of 8, 9, or 12 inches. These adjustments will be tested both during short sessions and overnight at home to compare their effects on blood pressure. The study uses a randomized design without masking to evaluate these non-drug interventions. During the study, researchers will monitor blood pressure from 10 PM to 8 AM, including during acute one-hour elevation sessions. They will also measure overnight urine volume to assess effects on fluid balance. Participants will be assessed for changes in systolic blood pressure and other health markers while sleeping with the bed in different elevated positions. The total participation period varies depending on the intervention and home use phases.

CONDITIONS

Brief Title

Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with autonomic failure and supine hypertension from all races
  • Males and females aged 18 to 85 years
Not Eligible

You will not qualify if you...

  • Medical students
  • Pregnant women
  • High-risk patients such as those with heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction
  • History of serious allergies or asthma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Overnight periods during the trial

Participants experience different methods of head elevation during sleep to assess the effects on supine blood pressure. This includes periods of whole bed tilt and trunk elevation using wedge pillows, both in clinical settings and at home.

Multiple overnight sessions depending on assigned intervention

Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

B

Bonnie K Black, RN

L

Luis E. Okamoto, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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