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Completed

NCT Number: NCT03676582

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Teaching Hospitals NHS FT

Sheffield, Yorkshire, S10 2JF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Acoustic analysis plus pulse oximetry

Diagnostic Test

Acoustic analysis plus pulse oximetry

Primary outcomes

  1. Presence or Absence of Aspiration

    Time frame: 1 hour

    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

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • University of Cambridge

Registry information

Official study title

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

Acronym: AspiRATE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2018
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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