The Passy Muir Swallowing Self Training Device

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01765673

Acronym

PMSST

Enrollment

Registered

2013-01-10

Start date

2013-01-01

Completion date

2016-02-22

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Dysphagia

Keywords

Swallowing, Stroke, Sensory stimulation, Home based therapy, Head and Neck Cancer

Brief summary

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.

Interventions

DEVICEVibrotactile stimulation

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in Discomfort Level 30 Hz	During one session within 1 hour	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.
Change in Discomfort 70 Hz	During one session within 1 hour	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.
Change in Discomfort 110 Hz	During one session within 1 hour	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.
Change in Discomfort 150 Hz	During one session within 1 hour	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.
Change in Discomfort 70 & 110 Hz	During one session within 1 hour	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.
Change in Urge to Swallow After 30 Hz Stimulation	During one session within 1 hour	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.
Change in Swallow Frequency 4 kPa	During one session within 1 hour	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
Change in Swallow Frequency 6 kPa	During one session within 1 hour	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
Percent Change in Swallow Frequency Pulse vs Continuous	During one session within one hour	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
Change in Swallow Initiation Time	During one session within 1 hour	Change in swallow initiation time (ms) from swallow reaction time during vibrotactile stimulation minus reaction time with sham (no) stimulation
Change in Swallowing Frequency 2 kPa	During one session within 1 hour	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
Change in Urge to Swallow 70 Hz	During one session within 1 hour	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.
Change in VAS Urge to Swallow 110 Hz	During one session within 1 hour	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.
Change in VAS Urge to Swallow 150 Hz	During one session within 1 hour	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.
Change in VAS Urge to Swallow 70 & 110 Hz	During one session within 1 hour	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.

Countries

United States

Participant flow

Pre-assignment details

Of the 13 enrolled, 1 did not pass cognitive testing and did not participate in the study

Participants by arm

Arm	Count
Vibrotactile Stimulation in Dysphagia 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 Vibrotactile stimulation: 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.	12
Total	12

Arm

Count

Vibrotactile Stimulation in Dysphagia

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 Vibrotactile stimulation: 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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	No transportation for 2nd/3rd visits	1

Baseline characteristics

Characteristic	Vibrotactile Stimulation in Dysphagia
Age, Continuous	64.3 years STANDARD_DEVIATION 9.83
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	11 Participants
Region of Enrollment United States	12 Participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 12
other Total, other adverse events	0 / 12
serious Total, serious adverse events	0 / 12

Outcome results

Primary

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)