Videofluoroscopic Swallowing Study (VFSS)

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

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

Interventions

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.

Sponsors & Collaborators

• Cytel Inc.

  collaborator INDUSTRY

• Regulatory and Clinical Research Institute Inc

  collaborator OTHER

• Nestec Ltd.

  collaborator INDUSTRY

• Société des Produits Nestlé (SPN)

  lead INDUSTRY

Principal Investigators

• Natalia Muhlemann, MD · Nestle Health Science

• Richard Harvey, MD · Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-24

Primary Completion

2018-07-23

Completion

2018-07-23

FDA Device

Yes

Countries

• United States
• Finland

Study Locations