NCT03676582

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Dysphagia, Oropharyngeal

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Acoustic analysis plus pulse oximetry	Acoustic analysis plus pulse oximetry

Timeline

• Start date: 2018-05-24
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2018-09-18
• Last updated: 2025-03-21
• Results posted: 2025-03-21

Locations

1 site across 1 country: United Kingdom