Use of the Passy Muir Swallowing Self Trainer
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|ClinicalTrials.gov Identifier: NCT02848664|
Recruitment Status : Completed
First Posted : July 28, 2016
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment|
|Stroke Brain Injury Head and Neck Cancer||Device: Dysphagia retraining with 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 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.
- To develop and evaluate training for participants and caregivers to use the self-trainer.
- To gather participant feedback on the use of the device after 3 months of daily practice.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Dysphagia retraining with device
Participants with dysphagia received baseline testing of dysphagia and dysphagia handicap. Then received training on how to use a vibrotactile device for self training at home. They used the device for 3 months and returned for re-evaluation on testing of dysphagia and feedback on the device
Device: Dysphagia retraining with device
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
Other Name: Passy Muir Swallowing Self Trainer
- Change in Dysphagia Outcome and Severity Scale (DOSS) Rating [ Time Frame: From before onset of device use to return 3 months later ]
An ordinal scale of 7 levels of severity of swallowing disorder with 1 being the lowest level and 7 being the highest level.
Level 1 is Severe dysphagia Nothing per oral and unable to tolerate any per oral liquid/substance safely.
Level 2 is Moderately severe dysphagia, requires maximum assistance or use of strategies with partial per oral only, tolerates at least one consistency safely with total use of strategies.
Level 3 is Moderate Dysphagia, requires total assist, supervision, or strategies with two or more consistencies restricted.
Level 4 is Mild-moderate Dysphagia, Requires intermittent supervision/cueing, one or two consistencies restricted level 5 is Mild dysphagia: requires distant supervision may need one diet consistency restricted Level 6 Within functional limits, modified independence Level 7 Normal in all situations
- Dysphagia Handicap Index (DHI) [ Time Frame: From before onset of device use to return 3 months later ]Total handicap Score from 0 (no Handicap) to 100 (Severe Handicap)
- Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure [ Time Frame: From before onset of device use to return 3 months later ]Calibrated kinematic measures from videofluoroscopic imaging during a modified barium swallow study. Computed the change in peak elevation in millimeters during swallowing from the rest position before swallowing for two structures: the larynx and the hyoid bone. The peak elevation of the two structures were compared by subtracting the hyoid peak elevation from the laryngeal peak elevation. If the measure was positive the larynx was elevated to a greater degree than the hyoid bone resulting in vestibule closure and airway protection during the swallow.
- Cortical Activation for Swallowing [ Time Frame: From before onset of device use to return 3 months later ]The level of cortical activation for swallowing was measured using near infra-red spectroscopy. Overall blood oxygenation level during swallowing was compared with the level during a non activation period prior to swallowing. To compute Z scores, the change in overall level between swallowing and prior to swallowing was divided by the standard deviation of the level prior to swallowing. The Z scores measured prior to and post device use for 3 months were compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848664
|United States, Virginia|
|James Madison University|
|Harrisonburg, Virginia, United States, 22807|
|Principal Investigator:||Erin Kamarunas, PhD||James Madison University|