Suspected dysphagia and/or aspiration Digestive System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 16+ years 2. Undergoing videofluoroscopy or FEES for suspected dysphagia and/or aspiration 3. Capacity to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Tracheostomy in place or previous tracheostomy 2. Active or previously treated cancer of the aerodigestive tract in the head and neck (i.e., not including local thyroid, salivary and skin malignancy) 3. Loss of skin integrity over front of neck 4. Contact sensitivity or allergy to any external component of the worn device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device function in clinical practice determined using data quality and ease-of-use as markers at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Device diagnostic accuracy preliminary analysis using swallow acoustic data alongside videofluoroscopy and FEES-based diagnoses in patients with dysphagia at a single timepoint (sensitivity and specificity using videofluoroscopy as the gold standard, at a cohort and per patient level, using standard 2 x 2 tables) | — |
Countries
England, United Kingdom