Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT03721393
Brief Summary:
To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.
To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.
Detailed Description:
This is a non-randomized feasibility study that will enroll up to 50 participants that have undergone a previous autonomic reflect screen (ARS) assessment and were either diagnosed with OH or reflex syncope, or considered to be control subjects for this study.
A maximum of 20 subjects diagnosed with reflex syncope, a maximum of 10 subjects diagnosed with OH and a maximum of 10 control subjects will be enrolled. There will be one study visit per subject.
Study:
NCT03721393
Study Brief:
Protocol Section:
NCT03721393