Dysphagia Study Using Novel Microphone Device

NCT07251140 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY000090532025P011062
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dysphagia; Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to apply device to patients

  Up to 30 min post-intervention

Study Arms (1)

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.

Device: Microphone device

Interventions

Microphone device 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.

Novel Acoustic Biopatch for the Investigation of Dysphagia Cohort

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Head and neck cancer treatment history

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hyojung Choo, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyojung Choo, PhD

CONTACT

404-727-3727; hyojung.choo@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 26, 2025
• Study Start: October 12, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)