Trial Outcomes & Findings for The Passy Muir Swallowing Self Training Device (NCT NCT01765673)

Results Overview

Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

Recruitment status

COMPLETED

Target enrollment

13 participants

Primary outcome timeframe

During one session within 1 hour

Results posted on

2017-11-14

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study No transportation for 2nd/3rd visits	1

Baseline Characteristics

The Passy Muir Swallowing Self Training Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Age, Continuous	64.3 years STANDARD_DEVIATION 9.83 • n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	12 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Swallow Frequency 30 Hz	0.512 Change in swallows/min Standard Deviation 1.358

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Swallow Frequency 70 Hz	0.747 Change in Swallows/min Standard Deviation 0.924

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Swallow Frequency 110 Hz	0.849 Change in swallows/min Standard Deviation 1.102

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Swallow Frequency 150 Hz	0.110 Change in swallows/min Standard Deviation 1.033

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=11 Participants 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.
Change in Swallowing Frequency 70 & 110 Hz	0.246 Change in swallows/min Standard Deviation 0.967

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Urge to Swallow After 30 Hz Stimulation	18.83 Change in VAS Urge to Swallow Standard Deviation 27.679

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Urge to Swallow 70 Hz	13.167 Change in VAS Urge to Swallow Standard Deviation 24.207

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in VAS Urge to Swallow 110 Hz	12.75 Change in VAS Urge to Swallow Standard Deviation 29.394

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in VAS Urge to Swallow 150 Hz	14.75 Change in VAS Urge to Swallow Standard Deviation 23.437

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=11 Participants 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.
Change in VAS Urge to Swallow 70 & 110 Hz	2.273 Change in VAS Urge to Swallow Standard Deviation 33.589

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Discomfort Level 30 Hz	2.750 Change in discomfort Standard Deviation 5.083

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Discomfort 70 Hz	5.25 Change in discomfort Standard Deviation 11.825

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Discomfort 110 Hz	4.083 Change in discomfort Standard Deviation 11.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Discomfort 150 Hz	5.583 Change in discomfort Standard Deviation 11.493

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=11 Participants 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.
Change in Discomfort 70 & 110 Hz	5.273 Change in discomfort Standard Deviation 13.92

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Swallowing Frequency 2 kPa	1.417 Change in Swallow/min Standard Deviation 1.975

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Swallow Frequency 4 kPa	2.0 Change in swallows/min Standard Deviation 3.411

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=12 Participants 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.
Change in Swallow Frequency 6 kPa	1.5 Change in swallows/min Standard Deviation 5.885

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=10 Participants 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.
Percent Change in Swallow Frequency Pulse vs Continuous	37.5 percent change Standard Deviation 126.519

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation in Dysphagia n=8 Participants 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.
Change in Swallow Initiation Time	372 millisseconds Standard Deviation 3092

Adverse Events

Vibrotactile Stimulation in Dysphagia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christy Ludlow

James Madison University

Phone: 540-937-3007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place