Dysphagia, Oropharyngeal
Conditions
Keywords
swallowing disorders, instrumental swallow assessment, acoustic analysis, respiratory changes
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.
Interventions
DIAGNOSTIC_TESTAcoustic analysis plus pulse oximetry
Acoustic analysis plus pulse oximetry
Sponsors
University of Cambridge
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stroke Patients Stroke patients - with acquired dysphagia | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Stroke Patients | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 20 Participants | — |
| Age, Categorical Between 18 and 65 years | 5 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 25 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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
Time frame: 1 hour
Population: Stroke patients with acquired dysphagia undergoing videofluoroscopy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Swallowing Events | Presence or Absence of Aspiration | 42 swallowing events with aspiration |