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

Completed

• Conditions: Dysphagia, Oropharyngeal

• Registration Number: NCT03676582
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2018-05-24
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-18
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Results First Submitted: 2022-07-14
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Results First Posted: 2025-03-21
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence or Absence of Aspiration	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

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS FT; 🇬🇧 Sheffield, Yorkshire, United Kingdom