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

NHS Foundation Trust logo

NHS Foundation Trust

Status

Completed

Conditions

Dysphagia, Oropharyngeal

Treatments

Diagnostic Test: Acoustic analysis plus pulse oximetry

Study type

Observational

Funder types

Other

Identifiers

NCT03676582
STH19484

Details and patient eligibility

About

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

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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