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| ID | Type | Description | Link |
|---|---|---|---|
| 2025P011062 | Other Identifier | Emory IRB |
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This study aims to collect swallowing acoustics with a novel non-invasive wearable surface microphone device during routine work-up, videofluoroscopic swallow study (VFSS), of patients with dysphagia (swallowing trouble). The collected microphone data will be analyzed to find the pattern of abnormal swallowing by machine learning algorithm.
Difficulty swallowing is a very common laryngeal problem affecting many individuals. This study aims to optimize and validate a device to detect dysphagia without invasive procedures. This is an investigational nanomembrane patch, which is a thin film, that will be attached to the subject's chin to check the activity of their muscles. The patch is designed to determine the movement of their muscles and acoustics while swallowing.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Acoustic Biopatch for the Investigation of Dysphagia Cohort | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microphone device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Normalized Surface Acoustic Swallowing Signal | Surface acoustic swallowing signals will be collected using a wearable biopatch containing a microphone, placed on study participants. Raw acoustic data will be recorded in voltage and subsequently normalized against background acoustic levels, resulting in a unitless measure expressed in arbitrary units (a.u.). | Up to 30 min post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Time to apply device to patients | Time to apply the device to patients will be recorded in minutes. | Up to 30 min post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyojung Choo, PhD | Contact | 404-727-3727 | hyojung.choo@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hyojung Choo, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |