The Passy Muir Swallowing Self Training Device

Completed

Conditions studied: Oropharyngeal Dysphagia

In brief

This is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).

Key facts

Study ID

NCT01765673

Run by

James Madison University

People needed

13

Starts

2013-01-01

Expected to finish

2016-02-22

Last updated by the study team

2017-11-14

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stroke or post radiation for the treatment of head and neck cancer
• Dysphagia with a score of 2 or greater on the Penetration/Aspiration Scale OR a Mann Assessment of Swallowing Ability ordinal risk rating of "probable" or "definite"

You may not qualify if…

• Neck injury
• Epilepsy
• Neurological disorder other than stroke
• Psychiatric illness other than depression
• Uncontrolled gastroesophageal reflux disease
• Inability to communicate secondary to significant speech or language problems
• Inability to maintain alertness for 1 hour
• Significant health concerns that would put the participant at risk

Where it is running

• James Madison University and Rockingham Memorial Hospital — Harrisonburg, Virginia, United States

Full record on ClinicalTrials.gov

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