The Passy Muir Swallowing Self Training Device "PMSST"

Completed

Phase N/A Results

Trial Description

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

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.

Conditions

Interventions

  • Passy Muir Swallowing Self-Trainer Device
    Other Names: PMSST; Swallowing Self-Trainer
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Participants with swallowing deficits post stroke
  • Vibrotactile stimulation Device
    Other Names: Passy Muir Swallowing Serlf Trainer
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Vibrotactile Stimulation in Dysphagia
    Description: 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.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Participants who have swallowing problems secondary to a stroke or following radiation for the treatment of head and neck cancer

Outcomes

Type Measure Time Frame Safety Issue
Primary Frequency of swallowing During intervention No
Secondary Perceived urge to swallow During intervention No
Primary Change in Swallow Frequency 30 Hz During one session within 1 hour
Primary Change in Swallow Frequency 70 Hz During one session within 1 hour
Primary Change in Swallow Frequency 110 Hz During one session within 1 hour
Primary Change in Swallow Frequency 150 Hz During one session within 1 hour
Primary Change in Swallowing Frequency 70 & 110 Hz During one session within 1 hour
Secondary Change in Urge to Swallow After 30 Hz Stimulation During one session within 1 hour
Secondary Change in Urge to Swallow 70 Hz During one session within 1 hour
Secondary Change in VAS Urge to Swallow 110 Hz During one session within 1 hour
Secondary Change in VAS Urge to Swallow 150 Hz During one session within 1 hour
Secondary Change in VAS Urge to Swallow 70 & 110 Hz During one session within 1 hour
Secondary Change in Discomfort Level 30 Hz During one session within 1 hour
Secondary Change in Discomfort 70 Hz During one session within 1 hour
Secondary Change in Discomfort 110 Hz During one session within 1 hour
Secondary Change in Discomfort 150 Hz During one session within 1 hour
Secondary Change in Discomfort 70 & 110 Hz During one session within 1 hour
Secondary Change in Swallowing Frequency 2 kPa During one session within 1 hour
Secondary Change in Swallow Frequency 4 kPa During one session within 1 hour
Secondary Change in Swallow Frequency 6 kPa During one session within 1 hour
Secondary Percent Change in Swallow Frequency Pulse vs Continuous During one session within one hour
Secondary Change in Swallow Initiation Time During one session within 1 hour

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