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

June 8, 2022 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Yorkshire
      • Sheffield, Yorkshire, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS FT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults over the age of 18 years with acquired dysphagia

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

University of Cambridge

Investigators

  • Principal Investigator: Sue Pownall, Ph.D, Sheffield Teaching Hospitals NHS FT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

September 14, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH19484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

As this is a proof of concept study, ethical approval has been secured for sharing of anonymised patient data with research study named collaborators for input advice on advanced data analysis. This is included on patient information and recruitment processes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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