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Videofluoroscopic Swallowing Study (VFSS) (PORSCHE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03387267
Recruitment Status : Terminated (Study terminated due to futility)
First Posted : January 2, 2018
Results First Posted : May 20, 2021
Last Update Posted : May 20, 2021
Sponsor:
Collaborators:
Cytel Inc.
Regulatory and Clinical Research Institute Inc
Nestec Ltd.
Information provided by (Responsible Party):
Nestlé

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Parkinson Disease Multiple Sclerosis Oropharyngeal Dysphagia Alzheimer Disease Dementia Device: Dysphagia Detection System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: The clinical trial will initially start as a 3-look group sequential design (GSD). Alpha-spending will be calculated using Lan-DeMets spending function (with O'Brien-Fleming parameter). At the first interim analysis (IA-1) the threshold on the ROC curve may be re-computed using the ROC curve generated using the IA-1 data, in which case, the validation trial would start afresh following IA-1 using a 2-look GSD. Data included in the IA-1 would no longer be used for the validation phase.
Masking: None (Open Label)
Masking Description: An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.
Primary Purpose: Screening
Official Title: A Prospective Multi-center Study Comparing the Performance of the Dysphagia Detection System (DDS) in Detecting Impaired Swallowing Safety and Efficiency as Compared to the Clinical Reference Method - Videofluoroscopic Swallowing Study
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : July 23, 2018
Actual Study Completion Date : July 23, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
single-arm Dysphagia Detection System
An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.
 Device: Dysphagia Detection System
The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba [ Time Frame: 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.

  2. AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba [ Time Frame: 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.

  3. The Sensitivity & Specificity for Swallow Efficiency Using THIN-Ba [ Time Frame: 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.

  4. The Sensitivity & Specificity for Swallow Efficiency Using MILD-Ba [ Time Frame: 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.

  5. The Sensitivity & Specificity for Swallow Efficiency Using MOD-Ba [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387267


Locations
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United States, California
Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, District of Columbia
Medstar Rehabilitation Hospital
Washington, District of Columbia, United States, 20010
United States, Illinois
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Marionjoy Rehabilitation Hospital
Wheaton, Illinois, United States, 60187
United States, Kentucky
Kentucky Clinic
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
New York Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10021
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
The Burke Medical Research Institute
White Plains, New York, United States, 10605
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Nestlé
Cytel Inc.
Regulatory and Clinical Research Institute Inc
Nestec Ltd.
Investigators
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Study Director: Natalia Muhlemann, MD Nestle Health Science
Principal Investigator: Richard Harvey, MD Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)
  Study Documents (Full-Text)

Documents provided by Nestlé:
Study Protocol  [PDF] September 25, 2017
Statistical Analysis Plan  [PDF] June 22, 2018

More Information
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Publications:

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03387267    
Other Study ID Numbers: 16.21.CLI
First Posted: January 2, 2018    Key Record Dates
Results First Posted: May 20, 2021
Last Update Posted: May 20, 2021
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Deglutition Disorders
Parkinson Disease
Multiple Sclerosis
Alzheimer Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases