Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT07251140

Conditions

Dysphagia

Stroke

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Microphone device

Study Details

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

Study ID

NCT07251140

Start date

Oct 12, 2025

Status verified date

Nov, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Normalized Surface Acoustic Swallowing Signal [ Time Frame: Up to 30 min post-intervention ]

Central Contacts and Locations

Central contacts

Hyojung Choo, PhD

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

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Hyojung Choo, PhD

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

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Hyojung Choo, PhD

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

More Information

Sponsor

Emory University

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-11-26.