CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Dysphagia retraining with devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02848664
NCT02848664N/ACompleted

Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia

James Madison University·observational·Posted Jul 28, 2016·Updated Mar 11, 2019

In Brief

An observational study evaluating Dysphagia retraining with device for Stroke and 2 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to develop appropriate training methods and gather participant feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST is a small device that provides external vibratory stimulation to the larynx during swallowing and swallowing training. A secondary purpose of the study is to determine how 3 months of use of the PMSST affects swallowing physiology, brain activation, oral intake and quality of life. This was an uncontrolled pilot study aimed at gaining patient feedback on use of the vibratory device.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPassy Muir Inc.

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 28, 2016
Enrollment StartAug 1, 2013
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.9 years ago

Interventions

Dysphagia retraining with devicedevice

Patients used the device for 60 trials of retraining swallowing at home each day and also had the device turned on throughout the day in automatic mode to intermittently trigger every few minutes to trigger a swallow for saliva control