Dysphagia, Stroke
Conditions
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.
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.
Interventions
DEVICEMicrophone 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.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized Surface Acoustic Swallowing Signal | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to apply device to patients | Up to 30 min post-intervention | Time to apply the device to patients will be recorded in minutes. |
Countries
United States
Contacts
Primary ContactHyojung Choo, PhD
Outcome results
None listed