Videofluoroscopic Swallowing Study (VFSS)

Not Applicable

Terminated

Conditions: Oropharyngeal Dysphagia
Multiple Sclerosis
Stroke
Parkinson Disease
Dementia
Alzheimer Disease

Registration Number: NCT03387267

Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary: The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.

Detailed Description: DDS signals and VFSS will be recorded simultaneously (for the same bolus) using barium contrast agent stimuli prepared in three consistencies: thin, mildly-thick and moderately-thick. Subjects will undergo VFSS with simultaneous DDS using up to 5 boluses of thin barium stimulus ("THIN-Ba"), and up to 4 boluses of barium thickened to mildly ("MILD-Ba") thick and up to 4 boluses of moderately ("MODERATE-Ba") thick barium consistencies using Resource Thicken Up Clear Nestlé Health Science (TUC). 4, 3 and 3 boluses for THIN-Ba, MILD-Ba and MOD-Ba will be analyzed using the classifier algorithms for sensitivity/specificity results. According to the exploratory trial, VFSS data for safety or efficiency can be missing for up to 14% boluses due to quality of VFSS recording. To compensate for potential losses of boluses due to missing gold standard (VFSS) data, 5, 4 and 4 boluses will be collected for the three consistencies respectively . The DDS signals will be sent to a dedicated application software installed at the CRO, which interprets the acceleration data and displays the examination result. The VFSS recording will be sent to CRO and provided for blinded assessment by the independent central VFSS laboratory.The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 452

Inclusion Criteria

Adult subjects (over 18 years of age)
Hospitalized subjects or outpatients identified as at risk of oropharyngeal dysphagia (using local practice)
Patients belong to one of the following groups:
- Stroke patients
- Traumatic brain injury
- Parkinson Disease (PD) stage III or higher by Hoehn and Yahr scale
- Multiple Sclerosis (MS) above age 60
- Alzheimer Disease (AD) or other Dementia
Other medically complex hospitalized subjects not covered by the exclusion criteria and identified as at risk of dysphagia
Subject is able to comply with VFSS protocol to diagnose dysphagia
Subject is able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained / or a consultee has consented on he subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves.

Exclusion Criteria

Presence of nasogastric / nasojejunal feeding tube at the time of VFSS test
Currently has a tracheostomy, or has had a tracheostomy in the past year
Had posterior cervical spine surgery and/or carotid endarterectomy in the last 6 months
Had significant surgery to the mouth and/or neck, for example resection for oral or pharyngeal cancer, radical neck dissection, anterior cervical spine surgery, orofacial reconstruction, pharyngoplasty, or thyroidectomy. Routine tonsillectomy and/or adenoidectomy are not excluded
Experienced non-surgical trauma to the neck (e.g., knife wound) resulting in musculoskeletal or nerve injury in the neck.
Received radiation or chemotherapy to the oropharynx or neck for cancer.
Allergy to oral radiographic contrast media (specifically barium)
Distorted oropharyngeal anatomy (e.g. pharyngeal pouch)
Cognitive impairment that prevents them from being able to comply with study instructions and procedures
Known to be pregnant at the time of enrollment
Currently has significant facial hair at the location of sensor adherence and are unwilling/unable to be shaved
Any patients the local investigator finds that participation would not be in patients' best interest

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Area Under the Receiver Operating Characteristic (ROC) Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for THIN-Ba	The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.	The primary efficacy of the DDS was measured as the sensitivity \& specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for thin barium (THIN-Ba) stimuli, using 5 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms. The ROC curve incorporates both sensitivity (true positive rate) and specificity (true negative rate) providing a single assessment incorporating both measures. The higher the total area under the curve, the greater the predictive power of the outcome. Primary analysis for futility was based on 242 subjects (Interim Analysis). The study was terminated based on futility as the AUC for primary endpoint (0.64) was less than the guiding futility bound of 0.75.

Secondary Outcome Measures

Name	Time	Method
The Sensitivity & Specificity for Swallow Efficiency Using THIN-Ba	The study procedure of simultaneous VFSS and DDS measurement using THIN-Ba was completed in one day for each subject.	The sensitivity \& specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for Thin barium (THIN-Ba) stimuli.
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba	The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.	The sensitivity \& specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for MODERATE barium (MOD-Ba) stimuli, using 3 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms. The higher the total AUC, the greater the predictive power of the outcome.
The Sensitivity & Specificity for Swallow Efficiency Using MOD-Ba	The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.	The sensitivity \& specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for MOD-Ba stimuli.
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba	The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) was completed in one day for each subject.	The sensitivity \& specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for MILD barium (MILD-Ba) stimuli, using 4 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms. The higher the total AUC, the greater the predictive power of the outcome.
The Sensitivity & Specificity for Swallow Efficiency Using MILD-Ba	The study procedure of simultaneous VFSS and DDS measurement using MILD-Ba was completed in one day for each subject.	The sensitivity \& specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for MILD-Ba.

Trial Locations

Locations (13): Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center
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Downey, California, United States
University of Colorado Denver
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Aurora, Colorado, United States
Medstar Rehabilitation Hospital
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Washington, District of Columbia, United States
Shirley Ryan AbilityLab
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Chicago, Illinois, United States
Marionjoy Rehabilitation Hospital
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Wheaton, Illinois, United States
Kentucky Clinic
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Lexington, Kentucky, United States
Boston Medical Center
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Boston, Massachusetts, United States
Henry Ford Health System
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Detroit, Michigan, United States
New York Presbyterian/Weill Cornell Medical Center
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New York, New York, United States
New York Presbyterian Hospital/Columbia University Medical Center
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New York, New York, United States
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Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center
🇺🇸Downey, California, United States