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To characterize the impact of orthostatic hypotension (OH) and Vasovagal syncope on signals measured using a wearable Holter monitor in the clinic and ambulatory setting.
To evaluate the relationship of signals measured from the Holter monitor with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.
This is a non-randomized feasibility study that will enroll up to 40 participants that have undergone a previous autonomic reflex screen (ARS) assessment and were either diagnosed with OH or reflex syncope or considered to be control subjects for this study.
A minimum of 20 subjects diagnosed with reflex syncope; a maximum of 15 subjects diagnosed with OH syncope and a maximum of 15 control subjects will be enrolled. There will be one in person study visit and a 21 day follow up period per subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Syncope group | Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope |
| |
| Control Group | Patients that have undergone an ARS assessment and are control subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable holter monitor | Device | Participants will be fitted with a minimum of one wearable Holter monitor and up to 2 monitors, placed on the skin that measures physiologic signals. Participants will wear the monitor(s) for up approximately 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Signal Detection via wearable holter monitor | Blood pressure (mmHg) will be monitored in the clinic and ambulatory setting. | From enrollment through the 21 day follow up period |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Signal Detection via wearable holter monitor | Heart rate (bpm) will be monitored in the clinic and ambulatory setting. | From enrollment through the 21 day follow up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that have previously undergone an ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley M Jensen, Masters of Science | Contact | 612-449-2918 | ashley.jensen@bsci.com | |
| Mojgan Goftari, PhD | Contact | mojgan.goftari@bsci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Foundation | Recruiting | Rochester | Minnesota | 55905 | United States |
IPD will not be shared due to privacy and confidentiality barriers in a small study population.
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D019462 | Syncope, Vasovagal |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Wearable holter monitor | Device | Participants will be fitted with a minimum of one wearable Holter monitor and up to 2 monitors, placed on the skin that measures physiologic signals. Participants will wear the monitor(s) for up approximately 21 days. |
|
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |