Wearable microphone patch to detect swallowing problems
Novel Acoustic Biopatch for the Investigation of Dysphagia
NA · Emory University · NCT07251140
We will test whether a thin wearable microphone patch can detect swallowing problems in adults aged 40–85 with stroke during their routine barium swallow (VFSS).
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT07251140 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study will attach an investigational nanomembrane microphone patch to the chin of adults with stroke who are undergoing a videofluoroscopic swallow study (VFSS) at Emory hospitals. Acoustic signals and muscle movement data will be recorded during routine VFSS and linked to clinical swallowing questionnaires and bedside test results. The collected microphone data will be analyzed with machine learning algorithms to identify patterns of abnormal swallowing. Demographic and clinical data will be stored in Emory REDCap for validation and future algorithm training.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40–85 with stroke or suspected stroke who are scheduled for a VFSS because of swallowing concerns.
Not a fit: Patients with BMI over 35, a history of head and neck cancer treatment, or those not undergoing VFSS are unlikely to benefit or be eligible for this device.
Why it matters
Potential benefit: If successful, the device could provide a quick, non-invasive way to detect or screen for dysphagia at the bedside without additional invasive testing.
How similar studies have performed: Prior work using neck acoustics and machine learning has shown promise for detecting dysphagia, but the specific nanomembrane microphone patch used here is novel and still requires validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University Hospital Midtown — Atlanta, Georgia, United States (RECRUITING)
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Hyojung Choo, PhD — Emory University
- Study coordinator: Hyojung Choo, PhD
- Email: hyojung.choo@emory.edu
- Phone: 404-727-3727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.