Microphone Device for Swallowing Difficulty

Recruiting at 1 trial location

Overseen By Hyojung Choo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Bmi>35, Head/neck cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new microphone device designed to help understand swallowing problems in people with dysphagia, or difficulty swallowing. The non-invasive device collects sound patterns from the throat during a routine swallowing study. Researchers aim to use this data to improve the diagnosis process with machine learning. Ideal participants have swallowing difficulties, possibly due to a stroke, and are scheduled for a specific swallowing test (VFSS). As an unphased trial, participants contribute to innovative research that may enhance future diagnostic methods for swallowing disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this microphone device is safe for use in patients with swallowing difficulties?

Research has shown that the microphone device for swallowing difficulties is safe and non-invasive for humans. As it is neither a drug nor a surgical procedure, the risks remain very low. The device, which includes a sensor and a circuit, is placed on the neck to listen to swallowing sounds.

Studies on similar devices have found no harm or discomfort. The primary purpose is to collect sound data, eliminating the risk of chemical or physical side effects. The device is designed for use with standard tests and does not interfere with them.

In summary, this microphone device is well-tolerated and poses little to no risk for study participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional dysphagia treatments that often rely on physical therapy or dietary modifications, the microphone device uses a novel acoustic biopatch to gather data about swallowing. This device captures sound data from the neck during swallowing and compares it with X-ray imaging to improve diagnostic accuracy with the help of AI. Researchers are excited about this approach because it could offer a non-invasive, more precise way to assess and monitor swallowing difficulties, potentially leading to more targeted and effective treatments.

What evidence suggests that this microphone device is effective for swallowing difficulty?

Research has shown that listening to swallowing sounds can help identify swallowing problems. In this trial, a new microphone device records these sounds and uses computers to analyze them. Early results suggest this method might effectively identify issues in both healthy individuals and those with swallowing difficulties. Listening to these sounds can reveal patterns that traditional methods might miss. This device could provide a new way to understand and possibly diagnose swallowing issues more accurately. ^{1 4 6 7 8}

Who Is on the Research Team?

Hyojung Choo, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals aged 40-85 who have had a stroke or are suspected to have one, and are experiencing swallowing difficulties. They must be scheduled for a videofluoroscopic swallow study (VFSS) as part of their care. People with a BMI over 35 or those treated for head and neck cancer cannot participate.

Inclusion Criteria

I have been diagnosed with or suspected to have had a stroke.

I have had a stroke and suffer from other neurological conditions.

I am between 40 and 85 years old.

Exclusion Criteria

My BMI is 35 or lower.

I have been treated for head and neck cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Device Application and Calibration

The biopatch device is applied and calibrated during the barium swallowing test

1 day

1 visit (in-person)

Data Collection and Analysis

Acoustic data is collected and analyzed using machine learning algorithms

Up to 30 minutes post-intervention

Follow-up

Participants are monitored for any immediate reactions post-device application

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Microphone device

Trial Overview The study is testing a new non-invasive microphone device that records swallowing sounds in patients with dysphagia during their routine VFSS. The recordings will be analyzed using machine learning to identify patterns of abnormal swallowing.

How Is the Trial Designed?

Group I: Novel Acoustic Biopatch for the Investigation of Dysphagia Cohort Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07251140?locStr=United+States&country=United+States&aggFilters=status%3A

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, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11762594/

Can Voice Parameters Provide Cutoff Values to Predict ... This study aims to determine the voice parameters that can predict the risk of dysphagia and to determine optimal cutoff values in individuals with multiple ...

3. medicaljournals.se medicaljournals.se/jrm/content/html/10.2340/16501977-0384

Acoustic analysis of swallowing sounds: A new technique ... The present study assessed a new technique, using a microphone and a notebook computer system, for acoustic analysis of the swallowing sounds of 4 types of ...

4. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/18070

Acoustic analysis of swallowing sounds: a new technique ... OBJECTIVE: To perform acoustic analysis of swallowing sounds, using a microphone and a notebook computer system, in healthy subjects and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19565158/

Acoustic analysis of swallowing sounds: a new technique ... To perform acoustic analysis of swallowing sounds, using a microphone and a notebook computer system, in healthy subjects and patients with dysphagia.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40381162/

Swallow sound acoustics: a cost-effective objective tool for ... The analysis revealed an inconsistent pattern of signal with multiple waves and prolonged duration in individuals with dysphagia. The duration ...

7. researchgate.net researchgate.net/publication/366528155_Swallow_Detection_with_Acoustics_and_Accelerometric-Based_Wearable_Technology_A_Scoping_Review

Swallow Detection with Acoustics and Accelerometric ... Only about half of the studies reported that the device attained an accuracy level of >90%, while a few studies reported poor performance with ...

8. repository.uantwerpen.be repository.uantwerpen.be/docstore/d:irua:9314

Acoustic assessment of airway protective maneuvers and ... Late radiation-associated dysphagia (RAD) can be defined as impaired swallowing safety and/or efficiency following intensive non-surgical ...