NCT03387267|TerminatedResultsDMCFDA Device
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Study terminated due to futility
PORSCHE
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
Sponsor study identifier
interventional
452
2 countries
13
Study Start
October 24, 2017
Actual (reported)Primary Completion
July 23, 2018
Actual (reported)Study Completion
July 23, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 23, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2017
Actual (reported)October 30, 2017
Actual (reported)January 2, 2018
Actual (reported)July 23, 2018
Actual (reported)July 23, 2018
Actual (reported)May 20, 2021
Actual (reported)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 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.
The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Medstar Rehabilitation Hospital
Washington D.C., District of Columbia, 20010, United States
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
Marionjoy Rehabilitation Hospital
Wheaton, Illinois, 60187, United States
Kentucky Clinic
Lexington, Kentucky, 40536, United States
Boston Medical Center
Clave 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.
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. doi: 10.1161/01.STR.0000177529.86868.8d. Epub 2005 Aug 18.
Natalia Muhlemann, MD
Nestle Health Science
Richard Harvey, MD
Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)
452 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2017
Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.
The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) was completed in one day for each subject.
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 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 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 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.
Contact the study team to confirm eligibility.
Boston, Massachusetts, 02118, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
New York Presbyterian/Weill Cornell Medical Center
New York, New York, 10021, United States
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032, United States
The Burke Medical Research Institute
White Plains, New York, 10605, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Helsinki University Central Hospital
Helsinki, 00029, Finland
Management of Stroke Rehabilitation Working Group. VA/DOD Clinical practice guideline for the management of stroke rehabilitation. J Rehabil Res Dev. 2010;47(9):1-43. No abstract available.
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. No abstract available.
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.
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.
Swets JA. The science of choosing the right decision threshold in high-stakes diagnostics. Am Psychol. 1992 Apr;47(4):522-32. doi: 10.1037//0003-066x.47.4.522.
Zammit-Maempel I, Chapple CL, Leslie P. Radiation dose in videofluoroscopic swallow studies. Dysphagia. 2007 Jan;22(1):13-5. doi: 10.1007/s00455-006-9031-x. Epub 2006 Oct 6.
Moro L, Cazzani C. Dynamic swallowing study and radiation dose to patients. Radiol Med. 2006 Feb;111(1):123-9. doi: 10.1007/s11547-006-0013-8. English, Italian.
First Posted
January 2, 2018
Study Start
October 24, 2017
Actual (reported)Primary Completion
July 23, 2018
Actual (reported)Study Completion
July 23, 2018
Actual (reported)Last Updated
December 19, 2025
Results First Posted
May 20, 2021
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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