Videofluoroscopic Swallowing Study (VFSS)

NCT03387267 | Terminated Results DMC FDA Device

• 1 other identifier: 16.21.CLI
• Study Type: interventional
• Target: 452
• Locations: 2 countries
• Sites: 13

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.

Conditions

Oropharyngeal Dysphagia; Alzheimer Disease; Stroke; Parkinson Disease; Multiple Sclerosis; Dementia

Outcome Measures

Primary Outcomes (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

  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.

Secondary Outcomes (5)

• AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba

  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.

Study Arms (1)

single-arm Dysphagia Detection System

OTHER

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

Interventions

Dysphagia Detection System DEVICE

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.

single-arm Dysphagia Detection System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Cytel Inc.: collaborator
• Regulatory and Clinical Research Institute Inc: collaborator
• Nestec Ltd.: collaborator

Study Sites (13)

Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Medstar Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Marionjoy Rehabilitation Hospital

Wheaton, Illinois, 60187, United States

Location

Kentucky Clinic

Lexington, Kentucky, 40536, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

New York Presbyterian/Weill Cornell Medical Center

New York, New York, 10021, United States

Location

New York Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

The Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (10)

• 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.

  PMID: 25850008 BACKGROUND

• 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.

  PMID: 20713754 BACKGROUND

• 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.

  PMID: 16109909 BACKGROUND

• 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.

  PMID: 21213454 BACKGROUND

• 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.

  PMID: 23412377 BACKGROUND

• 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.

  PMID: 25581840 BACKGROUND

• 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.

  PMID: 24026520 BACKGROUND

• 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.

  PMID: 1595983 BACKGROUND

• 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.

  PMID: 17024550 BACKGROUND

• 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.

  PMID: 16623312 BACKGROUND

MeSH Terms

Conditions

Stroke; Parkinson Disease; Multiple Sclerosis; Deglutition Disorders; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Kemuel Reyes
• Organization: Nestlé Health Science

Kemuel.Reyes@us.nestle.com

(908) 333-9379

Study Officials

• Natalia Muhlemann, MD

  Nestle Health Science

  STUDY DIRECTOR

• Richard Harvey, MD

  Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: January 2, 2018
• Study Start: October 24, 2017
• Primary Completion: July 23, 2018
• Study Completion: July 23, 2018
• Last Updated: December 19, 2025
• Results First Posted: May 20, 2021

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); US (12)