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Wearable device could warn you before you faint

NCT ID NCT07502599

Knowledge-focused Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 7 times

Summary

This study tests whether a wearable Holter monitor can detect early signs of fainting in people with orthostatic hypotension or reflex syncope. Forty adults who have already had a tilt-table test will wear the monitor for up to 21 days. The goal is to see if the device can pick up changes in blood pressure and heart rate that happen before a fainting episode.

What this could mean

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

What this could lead to
If successful, this could lead to better early warning systems for fainting episodes, helping people avoid falls or injuries.
What could go wrong
This is a small, early-stage study with only 40 participants, so results may not apply to everyone. It focuses on signal detection, not treatment.

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.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients that have previously undergone an ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects

Ages

18 years and older

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: * Willing and capable to provide informed consent * Age 18 or above * Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing). * Previously diagnosed with OH, Vasovagal syncope, OR control subjects assessed as normal, based on the ARS assessment. Participant enrollment shall be based on the type of diagnosis. * Willing to complete all required study activities. Exclusion Criteria: * Currently enrolled in another clinical trial that might interfere with data collection. * Subject is pregnant or planning to become pregnant during the study * Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc. * Have a prosthetic cardiac valve or previously underwent cardiac valve surgery. * Known allergy to materials used in the study (adhesive, ECG electrodes) * Diagnosed with syncope due to cardiologic causes. * Have had a myocardial infarction in the previous 90 days * Have been diagnosed with tachycardia that requires current medical treatment * Have any contraindications for exercise testing, tilt table test, Valsalva maneuver test or deep breathing test (judged by the study Principal Investigator)

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Conditions

The condition(s) this trial relates to.

Hypotension, Orthostatic orthostatic hypotension syncope, familial vasovagal Syncope, Vasovagal

As listed by the trial registrant

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

Orthostatic hypotension Reflex syncope

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic Foundation

    RECRUITING

    Rochester, Minnesota, 55905, United States

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