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NCT07251140NARecruiting

Dysphagia Study Using Novel Microphone Device

Emory University

Start Date

10/12/2025

Completion Date

9/30/2026

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 40 years to 85 years

Inclusion Criteria: * Diagnosis or suspected stroke * 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: * BMI\>35 as an exclusion criteria to recruit participants due to limited transmission of acoustics through increased subcutaneous fat. * Head and neck cancer treatment history

Interventions

DEVICE

Microphone device

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Conditions

DysphagiaStroke

Locations

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Emory University Hospital

Atlanta, Georgia 30322

United States