AspiRATE: Novel Intervention to Acoustically Detect Silent Aspiration in Acquired Dysphagia.

Study Overview
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Brief Summary
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This study will investigate whether silent aspiration during swallowing can reliably be detected using acoustic signal processing plus pulse oximetry.

Detailed Description
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This proof of concept trial, involving original research from a multicentre, multidisciplinary team, aims to establish whether silent aspiration can be detected in patients with dysphagia (swallowing difficulties), using a microphone array attached to the neck (to capture acoustic respiratory changes), pulse oximetry (to detect reduction in blood oxygen levels) and respiratory rate analysis, with data combined and analysed via post-capture signal processing techniques. The project aims to develop equipment and signal processing algorithms to a point where a novel intervention has been established that allows semi-automated detection of safe versus unsafe (aspiration) swallows. The intervention will be trialled in patients with dysphagia within standard videofluoroscopy clinics under clinical supervision. There will be on-going development of the intervention and signal processing algorithms during this process. Public and patient involvement work will feed back into the design process. If the intervention performs successfully in this proof-of-concept study, the investigators aim to proceed to a larger clinical trial to determine its sensitivity and specificity as a screening tool for aspiration, before final development into a commercial product.

Official Title
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The AspiRATE Study: a Proof-of-concept Assessment of a Novel Intervention to Acoustically Detect Silent Aspiration in Patients With Acquired Dysphagia.

Conditions
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Dysphagia, Oropharyngeal

Intervention / Treatment
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* Diagnostic Test: Acoustic analysis plus pulse oximetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dysphagia ± aspiration, age 18 and above Exclusion Criteria: Not competent for consent, previous neck surgery (not including thyroid surgery) cervical skin infection or defect pregnant (or unknown pregnancy status).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Acoustic analysis plus pulse oximetry|Acoustic analysis plus pulse oximetry|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of aspiration | Presence or absence of matter passing between or below the vocal cords during swallowing, particularly in the absence of cough reflex stimulation - novel intervention to acoustically detect silent aspiration in patients | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swallowing disorders, instrumental swallow assessment, acoustic analysis, respiratory changes