Study Results
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View full resultsBasic Information
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TERMINATED
NA
452 participants
INTERVENTIONAL
2017-10-24
2018-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
SCREENING
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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Cytel Inc.
INDUSTRY
Regulatory and Clinical Research Institute Inc
OTHER
Nestec Ltd.
INDUSTRY
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Natalia Muhlemann, MD
Role: STUDY_DIRECTOR
Nestle Health Science
Richard Harvey, MD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)
Locations
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Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Medstar Rehabilitation Hospital
Washington D.C., District of Columbia, United States
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Marionjoy Rehabilitation Hospital
Wheaton, Illinois, United States
Kentucky Clinic
Lexington, Kentucky, United States
Boston Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
New York Presbyterian/Weill Cornell Medical Center
New York, New York, United States
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States
The Burke Medical Research Institute
White Plains, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Helsinki University Central Hospital
Helsinki, , Finland
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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16.21.CLI
Identifier Type: -
Identifier Source: org_study_id