Fainting Detection and Early Warning Using a Wearable Monitor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-randomized feasibility study will enroll up to 40 adults who have had an autonomic reflex screen and were diagnosed with orthostatic hypotension, vasovagal syncope, or were normal controls. Participants will wear a Holter monitor during clinic visits and for a 21-day period to examine how monitor signals relate to symptom severity reported in standard questionnaires. The study includes one in-person visit and follow-up, with separate groups for OH, reflex syncope, and controls, to explore signal patterns and potential early warning indicators. Data analysis will focus on correlating wearable signals with symptom scales and clinical diagnoses.

Why it matters

Who can join: the full rules

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)

Where it's running

• Mayo Clinic Foundation
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Ashley M Jensen, Masters of Science
• Email: ashley.jensen@bsci.com
• Phone: 612-449-2918

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.