Dysphagia, OropharyngealAspiRATENCT03676582
AspiRATE: Novel Intervention to Acoustically Detect Silent Aspiration in Acquired Dysphagia.
An observational study of Dysphagia, Oropharyngeal, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will investigate whether silent aspiration during swallowing can reliably be detected using acoustic signal processing plus pulse oximetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Oropharyngeal
- What is being tested?
- Acoustic analysis plus pulse oximetry
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2018to 1 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults over the age of 18 years with acquired dysphagia
Who may be able to join
- Dysphagia ± aspiration,
- age 18 and above
Who cannot join
- Not competent for consent,
- previous neck surgery (not including thyroid surgery)
- cervical skin infection or defect
- pregnant (or unknown pregnancy status).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS FT
Sheffield, Yorkshire, S10 2JF
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysphagia, Oropharyngeal
- Being tested
- Acoustic analysis plus pulse oximetry
- Keywords
- swallowing disorders, instrumental swallow assessment, acoustic analysis, respiratory changes
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic analysis plus pulse oximetryDiagnostic test
Acoustic analysis plus pulse oximetry
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start24 May 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dysphagia, OropharyngealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Sue Pownall, Ph.D, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676582
- Sponsor's protocol ID
- STH19484
- Acronym
- AspiRATE
- Status last verified
- Mar 2025
- First submitted
- 14 Sep 2018
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AspiRATE Study: a Proof-of-concept Assessment of a Novel Intervention to Acoustically Detect Silent Aspiration in Patients With Acquired Dysphagia.
- ClinicalTrials.gov ID
- NCT03676582
- Acronym / sponsor ID
- AspiRATE / STH19484
- Conditions
- Dysphagia, Oropharyngeal
- Keywords
- swallowing disorders, instrumental swallow assessment, acoustic analysis, respiratory changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 24 May 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over the age of 18 years with acquired dysphagia
Key inclusion criteria (2 listed)
- Dysphagia ± aspiration,
- age 18 and above
Key exclusion criteria (4 listed)
- Not competent for consent,
- previous neck surgery (not including thyroid surgery)
- cervical skin infection or defect
- pregnant (or unknown pregnancy status).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic analysis plus pulse oximetryAcoustic analysis plus pulse oximetry | Diagnostic test | – |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Pownall, Ph.D principal investigator
Sheffield Teaching Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, Oropharyngeal, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or Absence of Aspiration (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.