Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-10-12
2026-09-30
Brief Summary
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Detailed Description
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This is a prospective cohort study. Dysphagic individuals with stroke visiting Emory University Hospital and Emory Midtown hospital will be asked to participate in the study. Individuals above the age of 40 years will be recruited. The study will be explained in detail to the individuals. After which a written signed consent will be obtained by research personnel before performing any research procedure. The biopatch will be placed and calibrated in dysphagic individuals at the time of performing a barium swallowing test. The collected medical (dysphagia questionnaire) data and demographic data will be collected and saved in Emory REDCap.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Novel Acoustic Biopatch for the Investigation of Dysphagia Cohort
The device is composed of a sensor (disposable part) and a circuit (reusable part).
The device will be applied to the anterior neck of dysphagia symptomatic patients who will be accessed with routine dysphagia investigation, such as standard swallowing evaluation with a modified barium swallow (VFSS). Device will be applied by authorized investigators to specific area to target specific neck muscles where no interference occurs for X-ray imaging (VFSS) interpretation. Acoustic data collected via device will be compared with X-ray imaging (VFSS) to train Convolutional neural network (CNN) algorithm to improve accuracy and to determine accuracy of device.
Microphone device
* An investigational nanomembrane patch, which is a thin film, is designed to collect acoustics while swallowing.
* The Microphone is also placed between the thyroid and cricoid cartilages to record swallowing acoustics.
Interventions
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Microphone device
* An investigational nanomembrane patch, which is a thin film, is designed to collect acoustics while swallowing.
* The Microphone is also placed between the thyroid and cricoid cartilages to record swallowing acoustics.
Eligibility Criteria
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Inclusion Criteria
* Stroke with additional neurological disorders
* Age between 40 and 85
* Male and Female
* Scheduled to VFSS due to suspected dysphagia, which is determined by bedside water swallowing test and EAT-10 questionnaire as a standard of care.
Exclusion Criteria
40 Years
85 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Hyojung Choo
Assistant Professor
Principal Investigators
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Hyojung Choo, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025P011062
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00009053
Identifier Type: -
Identifier Source: org_study_id
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