Dysphagia Study Using Novel Microphone Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microphone device.
- Who it may be relevant to
- Registry conditions: Dysphagia, Stroke. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Novel Acoustic Biopatch for the Investigation of Dysphagia
Overview
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
- 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.
Primary outcome measures
- Normalized Surface Acoustic Swallowing Signal [Time frame: Up to 30 min post-intervention]
Secondary outcome measures (1)
- Time to apply device to patients [Time frame: Up to 30 min post-intervention]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Emory University Hospital Midtown — Atlanta
- Emory University Hospital — Atlanta
Identifiers
NCT: NCT07251140 · STUDY00009053 · 2025P011062