Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HD074819 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Toronto | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
This investigation evaluates the effectiveness of a device called the Aspirometer, which uses high resolution cervical auscultation (HRCA), in detecting when food or liquids enter the airway (aspiration) of the person swallowing, whether the person swallowing shows signs of aspiration (coughing) or not.
This aim of the project seeks to discriminate normal from abnormal airway protection and kinematic functions noninvasively via machine-learning analysis of Aspirometer/HRCA (high resolution cervical auscultation) signals, with similar accuracy as human judgment of VF. Hypothesis: Advanced data analytics can detect pathological airway protection in HRCA signal signatures with 90% accuracy when compared to a human expert's airway protection ratings from VF images. Analytical algorithms that can learn from data (e.g., Bayes' learning) will be used to infer about the continuum of abnormal airway protection during swallowing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videofluoroscopic Swallow Study + Aspirometer | Experimental | Consecutively referred patients for modified barium swallow due to suspicion of dysphagia with aspiration, undergo the modified barium swallow test with Aspirometer sensors taped to the anterior neck. Signals are time-linked to images. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirometer | Device | a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result | Patients will undergo the Yale Swallow Protocol Screening Test and videofluoroscopic swallow study (VFS) while being concurrently monitored by the Aspirometer. Blinded trained human judges will score the screening test per its protocol indicating pass or fail based on the test's manual. Participants then immediately undergo a videofluoroscopic swallowing study during the same visit. Judgments of their penetration-aspiration scale (PAS) scores on the will serve as the gold standard for whether abnormal airway protection occurs during a swallow. The Yale swallow protocol involves a patient suspected of dysphagia with aspiration, drinking an aliquot of water (90mL) from a cup. Patient PASSES the screen if they drink the aliquot continuously without pausing, and if they do not cough or clear their throat after the swallow (one minute observation). Patients who PASS are assumed to NOT aspirate, patients who FAIL are assumed to aspirate. | day 1 |
| Percentage of PAS Scores That Were Accurately Predicted by the Aspirometer/HRCA, in Comparison to Modified Barium Swallow Test. | The Penetration Aspiration Scale is an 8-point ordinal scale validated in 1996. Scale range 1(best)-8(worst). Normal:
| day 1 |
Not provided
Not provided
Inclusion Criteria:
- referred by an attending physician as an inpatient, for a modified barium swallow examination due to suspected dysphagia and aspiration
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Coyle | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center Oakland campus | Pittsburgh | Pennsylvania | 15260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36873304 | Background | Khalifa Y, Mahoney AS, Lucatorto E, Coyle JL, Sejdic E. Non-Invasive Sensor-Based Estimation of Anterior-Posterior Upper Esophageal Sphincter Opening Maximal Distension. IEEE J Transl Eng Health Med. 2023 Feb 20;11:182-190. doi: 10.1109/JTEHM.2023.3246919. eCollection 2023. | |
| 35230537 | Background | Mahoney AS, Khalifa Y, Lucatorto E, Sejdic E, Coyle JL. Cervical Vertebral Height Approximates Hyoid Displacement in Videofluoroscopic Images of Healthy Adults. Dysphagia. 2022 Dec;37(6):1689-1696. doi: 10.1007/s00455-022-10414-8. Epub 2022 Mar 1. |
Not provided
Not provided
algorithms, not individual participant data, will be made available to other researchers through an FTP (file transfer protocol) site
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Videofluoroscopic Swallow Study + Aspirometer | Consecutively referred patients for modified barium swallow due to suspicion of dysphagia with aspiration, undergo the modified barium swallow test with Aspirometer sensors taped to the anterior neck. Signals are time-linked to images. Aspirometer: a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively Videofluoroscopic X-ray: MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
adult inpatients referred for VFSS test due to suspected dysphagia
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Videofluoroscopic Swallow Study + Aspirometer | Consecutively referred patients for modified barium swallow due to suspicion of dysphagia with aspiration, undergo the modified barium swallow test with Aspirometer sensors taped to the anterior neck. Signals are time-linked to images. Aspirometer: a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively Videofluoroscopic X-ray: MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result | Patients will undergo the Yale Swallow Protocol Screening Test and videofluoroscopic swallow study (VFS) while being concurrently monitored by the Aspirometer. Blinded trained human judges will score the screening test per its protocol indicating pass or fail based on the test's manual. Participants then immediately undergo a videofluoroscopic swallowing study during the same visit. Judgments of their penetration-aspiration scale (PAS) scores on the will serve as the gold standard for whether abnormal airway protection occurs during a swallow. The Yale swallow protocol involves a patient suspected of dysphagia with aspiration, drinking an aliquot of water (90mL) from a cup. Patient PASSES the screen if they drink the aliquot continuously without pausing, and if they do not cough or clear their throat after the swallow (one minute observation). Patients who PASS are assumed to NOT aspirate, patients who FAIL are assumed to aspirate. | Only 23/50 patients produced single discrete swallows during VFS. | Posted | Count of Participants | Participants | day 1 |
1 day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Videofluoroscopic Swallow Study + Aspirometer | Consecutively referred patients for modified barium swallow due to suspicion of dysphagia with aspiration, undergo the modified barium swallow test with Aspirometer sensors taped to the anterior neck. Signals are time-linked to images. Aspirometer: a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively Videofluoroscopic X-ray: MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Coyle | University of Pittsburgh | 4123836608 | jcoyle@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2022 | Feb 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2022 | Feb 17, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
Prospective study of patients referred for videofluoroscopic swallow study, consenting to parallel data collection of signals. No control group.
Not provided
Not provided
Judges, examiners were blinded to participant diagnosis. Measurement/analysis judges were blinded to participant diagnosis.
Not provided
|
| Videofluoroscopic X-ray | Device | MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so. |
|
|
| 34963825 | Background | Schwartz R, Khalifa Y, Lucatorto E, Perera S, Coyle J, Sejdic E. A Preliminary Investigation of Similarities of High Resolution Cervical Auscultation Signals Between Thin Liquid Barium and Water Swallows. IEEE J Transl Eng Health Med. 2021 Dec 10;10:4900109. doi: 10.1109/JTEHM.2021.3134926. eCollection 2022. |
| 33601360 | Background | Shu K, Coyle JL, Perera S, Khalifa Y, Sabry A, Sejdic E. Anterior-posterior distension of maximal upper esophageal sphincter opening is correlated with high-resolution cervical auscultation signal features. Physiol Meas. 2021 Apr 6;42(3). doi: 10.1088/1361-6579/abe7cb. |
| 32889627 | Background | Donohue C, Khalifa Y, Perera S, Sejdic E, Coyle JL. A Preliminary Investigation of Whether HRCA Signals Can Differentiate Between Swallows from Healthy People and Swallows from People with Neurodegenerative Diseases. Dysphagia. 2021 Aug;36(4):635-643. doi: 10.1007/s00455-020-10177-0. Epub 2020 Sep 5. |
| 31631954 | Background | Sejdic E, Malandraki GA, Coyle JL. Computational deglutition: Signal and image processing methods to understand swallowing and associated disorders. IEEE Signal Process Mag. 2019 Jan;36(1):138-146. doi: 10.1109/MSP.2018.2875863. Epub 2018 Dec 25. No abstract available. |
| 36417738 | Background | Khalifa Y, Donohue C, Coyle JL, Sejdic E. Autonomous Swallow Segment Extraction Using Deep Learning in Neck-Sensor Vibratory Signals From Patients With Dysphagia. IEEE J Biomed Health Inform. 2023 Feb;27(2):956-967. doi: 10.1109/JBHI.2022.3224323. Epub 2023 Feb 3. |
| 34428093 | Background | Donohue C, Khalifa Y, Mao S, Perera S, Sejdic E, Coyle JL. Characterizing Swallows From People With Neurodegenerative Diseases Using High-Resolution Cervical Auscultation Signals and Temporal and Spatial Swallow Kinematic Measurements. J Speech Lang Hear Res. 2021 Sep 14;64(9):3416-3431. doi: 10.1044/2021_JSLHR-21-00134. Epub 2021 Aug 24. |
| 34018024 | Background | Donohue C, Khalifa Y, Mao S, Perera S, Sejdic E, Coyle JL. Establishing Reference Values for Temporal Kinematic Swallow Events Across the Lifespan in Healthy Community Dwelling Adults Using High-Resolution Cervical Auscultation. Dysphagia. 2022 Jun;37(3):664-675. doi: 10.1007/s00455-021-10317-0. Epub 2021 May 20. |
| 35937555 | Background | Sabry A, Mahoney AS, Mao S, Khalifa Y, Sejdic E, Coyle JL. Automatic Estimation of Laryngeal Vestibule Closure Duration Using High- Resolution Cervical Auscultation Signals. Perspect ASHA Spec Interest Groups. 2020 Dec;5(6):1647-1656. doi: 10.1044/2020_persp-20-00073. Epub 2020 Dec 14. |
| 33100445 | Background | Mao S, Sabry A, Khalifa Y, Coyle JL, Sejdic E. Estimation of laryngeal closure duration during swallowing without invasive X-rays. Future Gener Comput Syst. 2021 Feb;115:610-618. doi: 10.1016/j.future.2020.09.040. Epub 2020 Sep 30. |
| 32650655 | Background | Coyle JL, Sejdic E. High-Resolution Cervical Auscultation and Data Science: New Tools to Address an Old Problem. Am J Speech Lang Pathol. 2020 Jul 10;29(2S):992-1000. doi: 10.1044/2020_AJSLP-19-00155. Epub 2020 Jul 10. |
| 32457331 | Background | Khalifa Y, Coyle JL, Sejdic E. Non-invasive identification of swallows via deep learning in high resolution cervical auscultation recordings. Sci Rep. 2020 May 26;10(1):8704. doi: 10.1038/s41598-020-65492-1. |
| 32419103 | Background | Donohue C, Mao S, Sejdic E, Coyle JL. Tracking Hyoid Bone Displacement During Swallowing Without Videofluoroscopy Using Machine Learning of Vibratory Signals. Dysphagia. 2021 Apr;36(2):259-269. doi: 10.1007/s00455-020-10124-z. Epub 2020 May 17. |
| 30919104 | Background | Zhang Z, Perera S, Donohue C, Kurosu A, Mahoney AS, Coyle JL, Sejdic E. The Prediction of Risk of Penetration-Aspiration Via Hyoid Bone Displacement Features. Dysphagia. 2020 Feb;35(1):66-72. doi: 10.1007/s00455-019-10000-5. Epub 2019 Mar 27. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Videofluoroscopic Swallow Study + Aspirometer | Consecutively referred patients for modified barium swallow due to suspicion of dysphagia with aspiration, undergo the modified barium swallow test with Aspirometer sensors taped to the anterior neck. Signals are time-linked to images. Aspirometer: a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively Videofluoroscopic X-ray: MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so. |
|
|
| Primary | Percentage of PAS Scores That Were Accurately Predicted by the Aspirometer/HRCA, in Comparison to Modified Barium Swallow Test. | The Penetration Aspiration Scale is an 8-point ordinal scale validated in 1996. Scale range 1(best)-8(worst). Normal:
| Posted | Count of Units | PAS scores | day 1 | PAS scores | PAS scores |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
Not provided
Not provided
Not provided
| D010038 | Otorhinolaryngologic Diseases |