Dysphagia Study Using Novel Microphone Device

NCT ID: NCT07251140

Last Updated: 2025-11-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-12

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dysphagia Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Microphone device

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

* Head and neck cancer treatment history
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Hyojung Choo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Emory University Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hyojung Choo, PhD

Role: CONTACT

404-727-3727

Facility Contacts

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Hyojung Choo, PhD

Role: primary

404-727-3727

Hyojung Choo, PhD

Role: primary

404-727-3727

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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