Trial Outcomes & Findings for Use of the Passy Muir Swallowing Self Trainer (NCT NCT02848664)
NCT ID: NCT02848664
Last Updated: 2019-03-11
Results Overview
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
COMPLETED
11 participants
From before onset of device use to return 3 months later
2019-03-11
Participant Flow
Potential patient participants were recruited from patients who had previously participated in protocol on The Passy Muir Swallowing Self Training Device, Voice and Swallowing Clinics, community hospitals, announcements in websites of patient support groups, and contacts with speech language pathologists specializing in dysphagia.
Exclusion of those with psychiatric, epilepsy, severe speech/language communication disorders, cognitive impairment, esophageal disorders, and inability to tolerate a nasal endoscopic examination. Inclusion criteria: 13 years or older, parental consent if under 18, stable medical condition and oropharyngeal dysphagia.
Participant milestones
| Measure |
Laryngeal Vibrotactile Stimulation
Participants with dysphagia received an external laryngeal vibratory stimulation device, The Passy Muir Swallowing Self Trainer, to assist with swallowing retraining. Participants and their caregivers received training to criterion on how to use the device and were then given a device to take home for 3 months for daily use in swallowing training and for saliva swallowing throughout the day. They were asked to use the device for a minimum of 60 practice trials of swallowing their own and to wear the device to assist with saliva swallowing. All participants were evaluated on their swallowing using modified barium swallow examination and patient questionnaires immediately before device training and on return 3 months later. They also completed questionnaires on the device characteristics on return.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
Laryngeal Vibrotactile Stimulation
Participants with dysphagia received an external laryngeal vibratory stimulation device, The Passy Muir Swallowing Self Trainer, to assist with swallowing retraining. Participants and their caregivers received training to criterion on how to use the device and were then given a device to take home for 3 months for daily use in swallowing training and for saliva swallowing throughout the day. They were asked to use the device for a minimum of 60 practice trials of swallowing their own and to wear the device to assist with saliva swallowing. All participants were evaluated on their swallowing using modified barium swallow examination and patient questionnaires immediately before device training and on return 3 months later. They also completed questionnaires on the device characteristics on return.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Adverse Event
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1
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Overall Study
no assistance for device training
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1
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Baseline Characteristics
Use of the Passy Muir Swallowing Self Trainer
Baseline characteristics by cohort
| Measure |
Laryngeal Vibrotactile Stimulation
n=7 Participants
Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.
Passy Muir Swallowing Self Trainer: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia
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|---|---|
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Age, Continuous
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56.4 years
STANDARD_DEVIATION 20.1 • n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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5 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=99 Participants
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Race (NIH/OMB)
White
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6 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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7 participants
n=99 Participants
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Functional Oral Intake Scale
1-Severe
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6 Participants
n=99 Participants
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Functional Oral Intake Scale
2-Moderate/Severe
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1 Participants
n=99 Participants
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Functional Oral Intake Scale
3-Moderate
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0 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: From before onset of device use to return 3 months laterPopulation: Patients with Severe/Moderate to Severe dysphagia, chronic for more than 6 months, nutrition is by enteric means, may be able to ingest one consistencies with supervision
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
Outcome measures
| Measure |
Laryngeal Vibrotactile Stimulation
n=7 Participants
Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.
Passy Muir Swallowing Self Trainer: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia
|
After Device Use for 3 Months
After vibrotactile device over 3 months at home for practicing swallowing and to manage salivary flow by swallowing during waking hours
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|---|---|---|
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Change in Dysphagia Outcome and Severity Scale (DOSS) Rating
No change on DOSS
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5 Participants
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—
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Change in Dysphagia Outcome and Severity Scale (DOSS) Rating
Improvement on DOSS
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2 Participants
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—
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PRIMARY outcome
Timeframe: From before onset of device use to return 3 months laterTotal handicap Score from 0 (no Handicap) to 100 (Severe Handicap)
Outcome measures
| Measure |
Laryngeal Vibrotactile Stimulation
n=7 Participants
Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.
Passy Muir Swallowing Self Trainer: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia
|
After Device Use for 3 Months
After vibrotactile device over 3 months at home for practicing swallowing and to manage salivary flow by swallowing during waking hours
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|---|---|---|
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Dysphagia Handicap Index (DHI)
Pre Device use DHI score
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61.143 units on a scale
Standard Deviation 17.199
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—
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Dysphagia Handicap Index (DHI)
Post Use DHI Score
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38.571 units on a scale
Standard Deviation 22.501
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—
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SECONDARY outcome
Timeframe: From before onset of device use to return 3 months laterPopulation: Only 5 patients were able to undergo a repeated modified barium swallow study after device use.
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.
Outcome measures
| Measure |
Laryngeal Vibrotactile Stimulation
n=5 Participants
Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.
Passy Muir Swallowing Self Trainer: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia
|
After Device Use for 3 Months
After vibrotactile device over 3 months at home for practicing swallowing and to manage salivary flow by swallowing during waking hours
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|---|---|---|
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Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure
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5.525 millimeters
Standard Deviation 4.338
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—
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SECONDARY outcome
Timeframe: From before onset of device use to return 3 months laterPopulation: Same patients before and after device use
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.
Outcome measures
| Measure |
Laryngeal Vibrotactile Stimulation
n=6 Participants
Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.
Passy Muir Swallowing Self Trainer: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia
|
After Device Use for 3 Months
n=6 Participants
After vibrotactile device over 3 months at home for practicing swallowing and to manage salivary flow by swallowing during waking hours
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|---|---|---|
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Cortical Activation for Swallowing
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18.042 Z score
Standard Error 17.391
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70.822 Z score
Standard Error 20.912
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Adverse Events
Laryngeal Vibrotactile Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Laryngeal Vibrotactile Stimulation
n=7 participants at risk
Patients using vibrotactile device over 3 months at home while practicing swallowing and to manage salivary by swallowing during waking hours
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Increase in temperature for more than 3 days
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42.9%
3/7 • Number of events 3 • 3 months
Severe Adverse Event: Diagnosis of Aspiration Pneumonia
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place