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Videofluoroscopic Swallowing Study (VFSS) (PORSCHE)

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ClinicalTrials.gov Identifier: NCT03387267
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
Cytel Inc.
Regulatory and Clinical Research Institute Inc
Nestec Ltd.
Information provided by (Responsible Party):
Nestlé

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
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
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019


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.



Primary Outcome Measures :
  1. The primary efficacy of the Dysphagia Detection System (DDS) will be measured as the sensitivity & specificity obtained from comparing the DDS swallow safety outcome simultaneously to the VFSS swallow safety outcome for thin barium (THIN-Ba) stimuli [ Time Frame: The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) will be completed in one day. ]
    The primary efficacy of the Dysphagia Detection System (DDS) will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow safety outcome (binary) simultaneously with the clinical reference standard VFSS swallow safety outcome (binary) for thin barium (THIN-Ba) stimuli, using 5 boluses per subject protocol. Swallowing safety describes risk of penetration-aspiration which describes impaired airway protection. The impaired swallowing safety is defined as Penetration Aspiration Scale (PAS) ≥ 3 as determined by VFSS.


Secondary Outcome Measures :
  1. The sensitivity & specificity DDS for swallow safety using MILD-Ba will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow safety outcome with the VFSS swallow safety outcome for MILD-Ba [ Time Frame: The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) will be completed in one day. ]
    The sensitivity & specificity DDS for swallow safety using mild barium (MILD-Ba) will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow safety outcome (binary) simultaneously with the clinical reference standard videofluoroscopic swallowing study (VFSS) swallow safety outcome (binary) for mild barium (MILD-Ba) stimuli, using 4 boluses per subject protocol. Swallowing safety describes risk of penetration-aspiration which describes impaired airway protection.The impaired swallowing safety is defined as Penetration Aspiration Scale (PAS) ≥ 3 as determined by VFSS.

  2. The sensitivity & specificity DDS for swallow efficiency using THIN-Ba will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome with the VFSS swallow efficiency outcome for THIN-Ba [ Time Frame: The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) will be completed in one day. ]
    The sensitivity & specificity DDS for swallow efficiency using thin barium (THIN-Ba) will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) simultaneously with the clinical reference standard VFSS (videofluoroscopic swallowing study) swallow efficiency outcome (binary) for thin barium (THIN-Ba) stimuli, using 5 boluses per subject protocol. Swallowing efficiency is described as the ability to clear a bolus through the pharynx in 2 swallows or less without leaving residue in the throat.The impaired swallowing efficiency is defined as at least 50% residue as determined by VFSS.

  3. The sensitivity & specificity DDS for swallow efficiency using MILD-Ba will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome with the VFSS swallow efficiency outcome for MILD-Ba [ Time Frame: The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) will be completed in one day. ]
    The sensitivity & specificity DDS for swallow efficiency using mild barium (MILD-Ba) will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) simultaneously with the clinical reference standard VFSS (videofluoroscopic swallowing study) swallow efficiency outcome (binary) for mild barium (MILD-Ba) stimuli,using 4 boluses per subject protocol. Swallowing efficiency is described as the ability to clear a bolus through the pharynx in 2 swallows or less without leaving residue in the throat.The impaired swallowing efficiency is defined as at least 50% residue as determined by VFSS.

  4. The sensitivity & specificity DDS for swallow safety using MOD-Ba will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow safety outcome with the VFSS swallow safety outcome for MOD-Ba [ Time Frame: The study procedure of simultaneous VFSS and DDS measurement using moderate barium (MOD-Ba) will be completed in one day. ]
    The sensitivity & specificity DDS for swallow safety using moderate barium (MOD-Ba) will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow safety outcome (binary) simultaneously with the clinical reference standard videofluoroscopic swallowing study (VFSS) swallow safety outcome (binary) for mild barium (MOD-Ba) stimuli, using 4 boluses per subject protocol. Swallowing safety describes risk of penetration-aspiration which describes impaired airway protection.The impaired swallowing safety is defined as PAS ≥ 3 as determined by VFSS.

  5. The sensitivity & specificity DDS for swallow efficiency using MOD-Ba will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome with the VFSS swallow efficiency outcome for MOD-Ba [ Time Frame: The study procedure of simultaneous VFSS and DDS measurement using moderate barium (MOD-Ba) will be completed in one day. ]
    The sensitivity & specificity DDS for swallow efficiency using moderate barium (MOD-Ba) will be measured as the sensitivity & specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) simultaneously with the clinical reference standard VFSS (videofluoroscopic swallowing study) swallow efficiency outcome (binary) for moderate barium (MOD-Ba) stimuli, using 4 boluses per subject protocol. Swallowing efficiency is described as the ability to clear a bolus through the pharynx in 2 swallows or less without leaving residue in the throat.The impaired swallowing efficiency is defined as at least 50% residue as determined by VFSS.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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


Contacts
Contact: Paula Kamman 952-224-2269 PORSCHE@rcri-inc.com

Locations
United States, California
Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center Recruiting
Downey, California, United States, 90242
Contact: Charles Liu, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Karen Orjuela, MD         
United States, District of Columbia
Medstar Rehabilitation Hospital Recruiting
Washington, District of Columbia, United States, 20010
Contact: Richard Zorowitz         
United States, Illinois
Shirley Ryan AbilityLab Recruiting
Chicago, Illinois, United States, 60611
Contact: Matthew Oswald, MD         
Marionjoy Rehabilitation Hospital Recruiting
Wheaton, Illinois, United States, 60187
Contact: Michael Pietrantoni         
United States, Kentucky
Kentucky Clinic Recruiting
Lexington, Kentucky, United States, 40536
Contact: Larry Goldstein, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Gintas Krisciunas         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Alice Silbergleit         
United States, New York
New York Presbyterian/Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Michael O'Dell, MD         
New York Presbyterian Hospital/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: David Seres, MD         
The Burke Medical Research Institute Recruiting
White Plains, New York, United States, 10605
Contact: Dylan Edwards, PhD         
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Claudio Milstein, MD         
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Contact: Lauri Soinne, MD         
Sponsors and Collaborators
Nestlé
Cytel Inc.
Regulatory and Clinical Research Institute Inc
Nestec Ltd.
Investigators
Study Director: Natalia Muhlemann, MD Nestle Health Science
Principal Investigator: Richard Harvey, MD Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)

Publications:
VA/DoD Clinical Practice Guideline for the October, 2010. Management of Stroke Rehabilitation

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03387267     History of Changes
Other Study ID Numbers: 16.21.CLI
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Parkinson Disease
Multiple Sclerosis
Alzheimer Disease
Dementia
Deglutition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases