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| Name | Class |
|---|---|
| University of Cambridge | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoustic analysis plus pulse oximetry | Diagnostic Test | Acoustic analysis plus pulse oximetry |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults over the age of 18 years with acquired dysphagia
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| Name | Affiliation | Role |
|---|---|---|
| Sue Pownall, Ph.D | Sheffield Teaching Hospitals NHS FT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospitals NHS FT | Sheffield | Yorkshire | S10 2JF | United Kingdom |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Stroke Patients | Stroke patients - with acquired dysphagia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with acquired dysphagia
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| ID | Title | Description |
|---|---|---|
| BG000 | Stroke Patients | Stroke patients - with acquired dysphagia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Stroke patients with acquired dysphagia undergoing videofluoroscopy | Posted | Number | swallowing events with aspiration | 1 hour |
|
|
From informed consent to study completion (Time frame per participant: up to 1 day)
As per protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stroke Patients | Stroke patients - with acquired dysphagia | 0 |
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Some swallowing events had to be excluded because of background noise in the recording.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lise Sproson | Sheffield Teaching Hospitals NHS Trust | 07753827428 | Lise.Sproson@nihr.ac.uk |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2018 | Aug 11, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D010092 | Oximetry |
| ID | Term |
|---|---|
| D001784 | Blood Gas Analysis |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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| D010038 | Otorhinolaryngologic Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D008919 | Investigative Techniques |