NCT07251140

Dysphagia Study Using Novel Microphone Device

Novel Acoustic Biopatch for the Investigation of Dysphagia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia
• Stroke

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-10-12
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study