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出境医 / 临床实验 / Videofluoroscopic Swallowing Study (VFSS) (PORSCHE)

Videofluoroscopic Swallowing Study (VFSS) (PORSCHE)

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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
Layout table for eligibility information
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

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Natalia Muhlemann, MD Nestle Health Science
Principal Investigator: Richard Harvey, MD Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)
Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE January 2, 2018
Results First Submitted Date  ICMJE December 18, 2020
Results First Posted Date  ICMJE May 20, 2021
Last Update Posted Date May 20, 2021
Actual Study Start Date  ICMJE October 24, 2017
Actual Primary Completion Date July 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2021) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017) 		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 6 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • 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 6 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.
  • 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 6 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.
  • 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. 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Videofluoroscopic Swallowing Study (VFSS)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Stroke
  • Parkinson Disease
  • Multiple Sclerosis
  • Oropharyngeal Dysphagia
  • Alzheimer Disease
  • Dementia
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Dysphagia Detection System
Publications *
  • Clavé P, Shaker R. Dysphagia: current reality and scope of the problem. Nat Rev Gastroenterol Hepatol. 2015 May;12(5):259-70. doi: 10.1038/nrgastro.2015.49. Epub 2015 Apr 7. Review.
  • Altman KW, Yu GP, Schaefer SD. Consequence of dysphagia in the hospitalized patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg. 2010 Aug;136(8):784-9. doi: 10.1001/archoto.2010.129.
  • Hinchey JA, Shephard T, Furie K, Smith D, Wang D, Tonn S; Stroke Practice Improvement Network Investigators. Formal dysphagia screening protocols prevent pneumonia. Stroke. 2005 Sep;36(9):1972-6. Epub 2005 Aug 18.
  • VA/DoD Clinical Practice Guideline for the October, 2010. Management of Stroke Rehabilitation
  • Donovan NJ, Daniels SK, Edmiaston J, Weinhardt J, Summers D, Mitchell PH; American Heart Association Council on Cardiovascular Nursing and Stroke Council. Dysphagia screening: state of the art: invitational conference proceeding from the State-of-the-Art Nursing Symposium, International Stroke Conference 2012. Stroke. 2013 Apr;44(4):e24-31. doi: 10.1161/STR.0b013e3182877f57. Epub 2013 Feb 14.
  • O'Horo JC, Rogus-Pulia N, Garcia-Arguello L, Robbins J, Safdar N. Bedside diagnosis of dysphagia: a systematic review. J Hosp Med. 2015 Apr;10(4):256-65. doi: 10.1002/jhm.2313. Epub 2015 Jan 12. Review.
  • Kertscher B, Speyer R, Palmieri M, Plant C. Bedside screening to detect oropharyngeal dysphagia in patients with neurological disorders: an updated systematic review. Dysphagia. 2014 Apr;29(2):204-12. doi: 10.1007/s00455-013-9490-9. Epub 2013 Sep 13. Review.
  • Swets JA. The science of choosing the right decision threshold in high-stakes diagnostics. Am Psychol. 1992 Apr;47(4):522-32.
  • Zammit-Maempel I, Chapple CL, Leslie P. Radiation dose in videofluoroscopic swallow studies. Dysphagia. 2007 Jan;22(1):13-5. Epub 2006 Oct 6.
  • Moro L, Cazzani C. Dynamic swallowing study and radiation dose to patients. Radiol Med. 2006 Feb;111(1):123-9. English, Italian.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 18, 2020) 		452
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2017) 		900
Actual Study Completion Date  ICMJE July 23, 2018
Actual Primary Completion Date July 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03387267
Other Study ID Numbers  ICMJE 16.21.CLI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE
  • Cytel Inc.
  • Regulatory and Clinical Research Institute Inc
  • Nestec Ltd.
Investigators  ICMJE
Study Director: Natalia Muhlemann, MD Nestle Health Science
Principal Investigator: Richard Harvey, MD Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)
PRS Account Nestlé
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯