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

Dysphagia, Oropharyngeal Clinical Trial

— AspiRATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676582
• Other study ID #: STH19484
• Status: Completed
• Start date: March 19, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2022
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Oropharyngeal

Intervention

Diagnostic Test:
• Acoustic analysis plus pulse oximetry
Acoustic analysis plus pulse oximetry

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS FT	Sheffield	Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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