An observational study in Dysphagia, Oropharyngeal, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational
This study will investigate whether silent aspiration during swallowing can reliably be detected using acoustic signal processing plus pulse oximetry.
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 25 is below the median of 97 across 207 observational studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 207 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults over the age of 18 years with acquired dysphagia
Exclusion Criteria:
Acoustic analysis plus pulse oximetry
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
Time frame: 1 hour
| Milestone | Stroke Patients |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
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
| swallowing events with aspiration | Swallowing Events |
|---|---|
| Presence or Absence of Aspiration | 42 |
Collected over From informed consent to study completion (Time frame per participant: up to 1 day). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stroke Patients | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
Patients with acquired dysphagia
| Age, Categorical(Participants) | Stroke Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 20 |
| Sex: Female, Male(Participants) | Stroke Patients |
|---|---|
| Female | 10 |
| Male | 15 |
| Race and Ethnicity Not Collected(Participants) | Stroke Patients |
|---|
| Region of Enrollment(participants) | Stroke Patients |
|---|---|
| United Kingdom | 25 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Sheffield Teaching Hospitals NHS Foundation Trust