Use of the Passy Muir Swallowing Self Trainer

Stroke Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

The investigators are currently developing the Passy Muir Swallowing Self-Trainer to continue treatment of dysphagia after the patient is discharged to home. The self-training device is worn around the neck with motors placed externally on the skin over the thyroid cartilage to provide vibratory stimulation to the larynx. The vibrations activate the sensory receptors inside the larynx which excite central nervous system (CNS) control for swallowing and can help the patient to initiate swallowing. Patients can use the self-training device at home to promote swallowing rehabilitation during daily swallowing practice. The device can also be programmed to vibrate at regular intervals throughout the day to promote saliva swallows. Using this method, the patient can continue their swallowing therapy independently and in a manner that is cost effective. A previous Phase I trial compared the clinical outcomes of 8 patients with chronic dysphagia using either an intramuscular electrical stimulation implant device or an external vibratory stimulator to practice swallowing daily at home. Functional outcomes of oral intake improved with both devices. As the external vibratory stimulation has the advantage of being external and completely noninvasive, it has been selected for further development as a self-training device. A second pilot study examined the effect of different frequencies of vibration on the swallowing frequency of healthy participants and found swallowing rate significantly increased from baseline when using a vibration of either 70 Hz or 150 Hz (Mulheren and Ludlow, 2017). Data has also been collected on the effect of different vibration characteristics on swallowing in participants who have swallowing problems after stroke (Kamarunas et al., in press).

Purpose: The purpose of this study is to allow patients with chronic dysphagia to use the Self-Trainer for daily swallowing practice in their home and collect feedback on device use and satisfaction and use. Objective information on the effectiveness of self-training for swallowing rehabilitation will also be gathered.

Objectives:

1. To develop and evaluate training for participants and caregivers to use the self-trainer.

2. To gather participant feedback on the use of the device after 3 months of daily practice.

3. To determine how 3 months of daily practice with the Passy Muir Swallowing Self-Trainer affects swallowing physiology, brain activation, oral intake, and quality of life in participants with chronic dysphagia. ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Head and Neck Cancer
• Head and Neck Neoplasms
• Stroke

• NCT number: NCT02848664
• Study type: Observational
• Source: James Madison University
• Status: Completed
• Start date: August 2013
• Completion date: August 2015