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NCT Number: NCT07251140

Dysphagia Study Using Novel Microphone Device

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Normalized Surface Acoustic Swallowing Signal

    Time frame: Up to 30 min post-intervention

    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.).

Secondary outcomes

  1. Time to apply device to patients

    Time frame: Up to 30 min post-intervention

    Time to apply the device to patients will be recorded in minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyojung Choo, PhD

CONTACT

[email protected]

404-727-3727

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Novel Acoustic Biopatch for the Investigation of Dysphagia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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