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Non-invasive swallow assessment device

Swallow assessment using a multi-channel non-invasive device: a feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11429329
Enrollment
27
Registered
2025-06-11
Start date
2023-11-09
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected dysphagia and/or aspiration Digestive System

Interventions

Screening: A member of the hospital clinical team will review the electronic medical record of patients attending routine and urgent videofluoroscopy (VF) or fibreoptic endoscopic evaluation of swallo

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
University of Cambridge
Collaborator

Eligibility

Sex/Gender
All

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

MeasureTime frame
Device function in clinical practice determined using data quality and ease-of-use as markers at a single timepoint

Secondary

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026