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Smart belt aims to stop fainting spells in nerve disorder patients

NCT ID NCT03482297

Symptom relief Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an automated abdominal binder that inflates when a person stands, applying pressure to help maintain blood pressure. It included 28 adults with autonomic failure and disabling orthostatic hypotension. Participants wore either the active binder or a sham version for one day, and researchers measured blood pressure changes and symptom relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
automated abdominal binder (device)
What this could lead to
If it works, this device could offer a non-drug way to reduce dizziness and fainting when standing, improving daily life for people with autonomic failure.
What could go wrong
This is an early-phase trial with only 28 participants, so results may not apply to everyone. The device may not provide meaningful benefit over a sham binder, and some people may find it uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

28 people

The number who actually took part.

Started

Mar 2018

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female subjects, age 40-80 years. * Possible or probable Multiple Systems Atrophy and Pure Autonomic Failure as defined by Consensus Criteria. * Neurogenic orthostatic hypotension defined as a ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes, and * Moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension Symptom Assessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10, with 0 reflecting absence of symptoms), within the first 10 minutes of the screening orthostatic stress test, and that have an impact in quality of life, as defined by the patient. * Able and willing to provide informed consent. Exclusion Criteria: * Pregnancy. * Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies. * History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months; symptomatic abdominal or inguinal hernias; severe gastroesophageal reflux; recent fractures or fissures of ribs, thoracic or lumbar spine; medical devices implanted on the abdominal wall or abdomen that would interfere with the binder; known abdominal or pelvic tumors, cysts or enlarged spleen; intolerance to any increase in intraabdominal pressure. * Pre-existing sustained supine hypertension ≥180/110. * Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension. * Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke or transient ischemic attacks). * Concomitant use of anticoagulants

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Conditions

The condition(s) this trial relates to.

Hypotension, Orthostatic multiple system atrophy orthostatic hypotension pure autonomic failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autonomic failure Multiple system atrophy Orthostatic hypotension Pure autonomic failure

Contacts and locations

Locations

  • Autonomic Dysfunction Center/ Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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