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.
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 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 (FDA IDE G0G0153). 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 significantly increased from baseline when using a vibration of 70 Hz on one side of the larynx and 110 Hz on the other side. Data has also been collected on the effect of different vibration characteristics on swallowing in participants who have swallowing problems after stroke.
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.
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.
- Passy Muir Swallowing Self Trainer Device
Other Names: Soyo Vibrotactile device III Intervention Desc: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia ARM 1: Kind: Experimental Label: Laryngeal vibrotactile stimulation Description: Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Training methods||During and up to 3 months after training the participant||No|
|Primary||Participant feedback on device use||During and up to 3 months after training the participant||Yes|
|Primary||Physiological changes after 3 months of device use||Changes between baseline and after 3 months of device use||No|
|Secondary||Device use/breakage||3 months after enrollment||No|