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

NCT03676582 | Completed Results

• 1 other identifier: STH19484
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysphagia, Oropharyngeal

Keywords

swallowing disorders; instrumental swallow assessment; acoustic analysis; respiratory changes

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Acoustic analysis plus pulse oximetry DIAGNOSTIC_TEST

Acoustic analysis plus pulse oximetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults over the age of 18 years with acquired dysphagia

You may qualify if:

• Dysphagia ± aspiration,
• age 18 and above

You may not qualify if:

• Not competent for consent,
• previous neck surgery (not including thyroid surgery)
• cervical skin infection or defect
• pregnant (or unknown pregnancy status).

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Limitations and Caveats

Some swallowing events had to be excluded because of background noise in the recording.

Results Point of Contact

• Title: Lise Sproson
• Organization: Sheffield Teaching Hospitals NHS Trust

Lise.Sproson@nihr.ac.uk

07753827428

Study Officials

• Sue Pownall, Ph.D

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 18, 2018
• Study Start: May 24, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Locations

GB (1)