The Passy Muir Swallowing Self Training Device

Study Overview
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Brief Summary
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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).

Detailed Description
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Participants were recruited who had chronic moderate to severe dysphagia following stroke or radiation treatment for head and neck cancer. Their frequency of swallowing was transduced with an accelerometer placed on the skin over the thyroid cartilage and inductive plethysmography bands placed over the rib cage and abdomen. When laryngeal elevation coincided with respiratory apnea a swallow was marked. Five different motor frequencies were evaluated to determine their effect on participants frequency of swallowing (swallows per minute). Frequencies were 30, 70, 110, and 150 Hz and a combination of 70 and 110 Hz. For each vibratory frequency the number of swallows per minute occurring during stimulation was compared with sham when the participant was wearing the device but the motor was not turned on. The frequency fo swallowing during stimulation was compared with the frequency of swallowing between stimulations. Visual analogue ratings of the urge to swallow and discomfort were also measured after each condition. Other parameters were the pressure between the motor and the skin (0, 2, 4, and 6 kPa) and swallow initiation time when stimulation was on and when it was not. Swallowing frequency with continuous versus pulsed stimulation was also compared.

Official Title
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Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke

Conditions
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Oropharyngeal Dysphagia

Intervention / Treatment
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* Device: Vibrotactile stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vibrotactile Stimulation in Dysphagia<br>A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort. | Device: Vibrotactile stimulation<br>* Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.<br>* Other names: Passy Muir Swallowing Serlf Trainer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Swallow Frequency 30 Hz | Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation) | During one session within 1 hour | 
| Change in Swallow Frequency 70 Hz | Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation) | During one session within 1 hour | 
| Change in Swallow Frequency 110 Hz | Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation) | During one session within 1 hour | 
| Change in Swallow Frequency 150 Hz | Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation) | During one session within 1 hour | 
| Change in Swallowing Frequency 70 & 110 Hz | Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation) | During one session within 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urge to Swallow After 30 Hz Stimulation | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed. | During one session within 1 hour | 
| Change in Urge to Swallow 70 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed. | During one session within 1 hour | 
| Change in VAS Urge to Swallow 110 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed. | During one session within 1 hour | 
| Change in VAS Urge to Swallow 150 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed. | During one session within 1 hour | 
| Change in VAS Urge to Swallow 70 & 110 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed. | During one session within 1 hour | 
| Change in Discomfort Level 30 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed. | During one session within 1 hour | 
| Change in Discomfort 70 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed. | During one session within 1 hour | 
| Change in Discomfort 110 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed. | During one session within 1 hour | 
| Change in Discomfort 150 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed. | During one session within 1 hour | 
| Change in Discomfort 70 & 110 Hz | At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed. | During one session within 1 hour | 
| Change in Swallowing Frequency 2 kPa | The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition | During one session within 1 hour | 
| Change in Swallow Frequency 4 kPa | The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition | During one session within 1 hour | 
| Change in Swallow Frequency 6 kPa | The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between increased pressure and no pressure condition | During one session within 1 hour | 
| Percent Change in Swallow Frequency Pulse vs Continuous | Percent Change= [(Number of swallows per minute from continuous stimulation -number of swallows per minute during pulsed stimulation) / number of swallows per minute during pulsed stimulation] X 100 | During one session within one hour | 
| Change in Swallow Initiation Time | Change in swallow initiation time (ms) from swallow reaction time during vibrotactile stimulation minus reaction time with sham (no) stimulation | During one session within 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home based therapy, Head and Neck Cancer, Swallowing, Stroke, Sensory stimulation