StrokeNCT02848664

Use of the Passy Muir Swallowing Self Trainer

An observational study of Stroke and Brain Injury, run by James Madison University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 100 years
Conditions the study is for: Stroke, Brain Injury, Head and Neck Cancer
What is being tested?: Dysphagia retraining with device
Type of treatment: Medical device
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Aug 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 100 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Chronic severe dysphagia requiring Percutaneous Endoscopic Gastrostomy (PEG) tube for nutrition

Who may be able to join

13 years or older
Stable medical condition
Diagnosed with oropharyngeal dysphagia confirmed by Modified Barium Swallow (MBS) baseline measure of the follow two scales:
Penetration-Aspiration Scale score of 2 or greater verified by modified barium swallow (Rosenbek et al., 1996) and/or
Functional Oral Intake Scale score of 5 or lower (Crary et al., 2005)
Folstein Mini-Mental State Examination (MMSE) score of 23 or greater indicating cognitive ability to follow directions and communicate preferences
Willingness to travel to Sentara Rockingham Memorial Hospital 2 or more times to undergo initial evaluation, device use training and checkup at 3 months.

Who cannot join

Pregnancy
Cardiac problems
history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia)
cardiac pacemaker in place
Highly-pigmented (dark) skin color is an exclusion criterion because near-infrared spectroscopy requires the measurement of the degree of absorption of different wavelengths of light after being reflected back through the scalp. Highly pigmented skin interferes with wavelength transmission, making the measurement of changes in absorption inaccurate.
Lack of a primary care physician who can be contacted if there are findings on the Magnetic Resonance Imaging (MRI) scan.

Show all 13Show fewer

Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware)
Presence of certain tattoos with ferromagnetic metal or permanent makeup, due to the exposure to high magnetic force through MRI procedures.
Subjects who were metal workers as a previous occupation will also be excluded due to the possibility of unknown/undetected metal in their body.
Volunteers with broken skin in the area that the functional Near Infra-Red Spectroscopy (fNIRS) probes will be placed on the scalp
Claustrophobia
Previous surgery that used surgical staples
Artificial joints

Trial locations and contacts

1 site in 1 country.

United States1 site

James Madison University
Harrisonburg, Virginia, 22807

Other trials in United States

About this study

Official title: Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia

The purpose of this study is to develop appropriate training methods and gather participant feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST is a small device that provides external vibratory stimulation to the larynx during swallowing and swallowing training. A secondary purpose of the study is to determine how 3 months of use of the PMSST affects swallowing physiology, brain activation, oral intake and quality of life. This was an uncontrolled pilot study aimed at gaining patient feedback on use of the vibratory device.

Read the detailed description

The investigators are currently developing the Passy Muir Swallowing Self-Trainer to continue treatment of dysphagia after the patient is discharged to home. The self-training device is worn around the neck with motors placed externally on the skin over the thyroid cartilage to provide vibratory stimulation to the larynx. The vibrations activate the sensory receptors inside the larynx which excite central nervous system (CNS) control for swallowing and can help the patient to initiate swallowing. Patients can use the self-training device at home to promote swallowing rehabilitation during daily swallowing practice. The device can also be programmed to vibrate at regular intervals throughout the day to promote saliva swallows. Using this method, the patient can continue their swallowing therapy independently and in a manner that is cost effective. A previous Phase I trial compared the clinical outcomes of 8 patients with chronic dysphagia using either an intramuscular electrical stimulation implant device or an external vibratory stimulator to practice swallowing daily at home. Functional outcomes of oral intake improved with both devices. As the external vibratory stimulation has the advantage of being external and completely noninvasive, it has been selected for further development as a self-training device. A second pilot study examined the effect of different frequencies of vibration on the swallowing frequency of healthy participants and found swallowing rate significantly increased from baseline when using a vibration of either 70 Hz or 150 Hz (Mulheren and Ludlow, 2017). Data has also been collected on the effect of different vibration characteristics on swallowing in participants who have swallowing problems after stroke (Kamarunas et al., in press).

Purpose: The purpose of this study is to allow patients with chronic dysphagia to use the Self-Trainer for daily swallowing practice in their home and collect feedback on device use and satisfaction and use. Objective information on the effectiveness of self-training for swallowing rehabilitation will also be gathered.

Objectives:

To develop and evaluate training for participants and caregivers to use the self-trainer.
To gather participant feedback on the use of the device after 3 months of daily practice.
To determine how 3 months of daily practice with the Passy Muir Swallowing Self-Trainer affects swallowing physiology, brain activation, oral intake, and quality of life in participants with chronic dysphagia.

Conditions: Stroke, Brain Injury, Head and Neck Cancer
Being tested: Dysphagia retraining with device
Medical subject headings: Stroke, Brain Injuries, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dysphagia retraining with deviceDevice
Also called Passy Muir Swallowing Self Trainer
Patients used the device for 60 trials of retraining swallowing at home each day and also had the device turned on throughout the day in automatic mode to intermittently trigger every few minutes to trigger a swallow for saliva control

Study groups in NCT02848664
Study group	Role	What they receive
Dysphagia retraining with device		Participants with dysphagia received baseline testing of dysphagia and dysphagia handicap. Then received training on how to use a vibrotactile device for self training at home. They used the device for 3 months and returned for re-evaluation on testing of dysphagia and feedback on the device Receives: Device: Dysphagia retraining with device

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Dysphagia Outcome and Severity Scale (DOSS) Rating
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
Measured: From before onset of device use to return 3 months later
Dysphagia Handicap Index (DHI)
Total handicap Score from 0 (no Handicap) to 100 (Severe Handicap)
Measured: From before onset of device use to return 3 months later

Secondary outcomes (2)

Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure
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.
Measured: From before onset of device use to return 3 months later
Cortical Activation for Swallowing
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.
Measured: From before onset of device use to return 3 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Aug 2015

First posted28 Jul 2016 (estimated)
Study startAug 2013
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02848664
Sponsor's protocol ID: #14-0064
Status last verified: Nov 2018
First submitted: 26 Jul 2016
Last updated: 11 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Mulheren RW, Ludlow CL. Vibration over the larynx increases swallowing and cortical activation for swallowing. J Neurophysiol. 2017 Sep 1;118(3):1698-1708. doi: 10.1152/jn.00244.2017. Epub 2017 Jul 5.
PubMed 28679839
Hegyi Szynkiewicz S, Mulheren RW, Palmore KW, O'Donoghue CR, Ludlow CL. Using devices to upregulate nonnutritive swallowing in typically developing infants. J Appl Physiol (1985). 2016 Oct 1;121(4):831-837. doi: 10.1152/japplphysiol.00797.2015. Epub 2016 Jul 28.
PubMed 27471240

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia
ClinicalTrials.gov ID: NCT02848664
Acronym / sponsor ID: #14-0064
Conditions: Stroke, Brain Injury, Head and Neck Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: James Madison UniversityUniversity, hospital or other
Collaborators: Passy Muir Inc.
Study start: Aug 2013 (actual)
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 28 Jul 2016 (estimated)
Results: Posted 11 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives:

To develop and evaluate training for participants and caregivers to use the self-trainer.
To gather participant feedback on the use of the device after 3 months of daily practice.
To determine how 3 months of daily practice with the Passy Muir Swallowing Self-Trainer affects swallowing physiology, brain activation, oral intake, and quality of life in participants with chronic dysphagia.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Dysphagia retraining with device	–	Device: Dysphagia retraining with deviceParticipants with dysphagia received baseline testing of dysphagia and dysphagia handicap. Then received training on how to use a vibrotactile device for self training at home. They used the device for 3 months and returned for re-evaluation on testing of dysphagia and feedback on the device

Who may qualify

Ages: 13 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Chronic severe dysphagia requiring Percutaneous Endoscopic Gastrostomy (PEG) tube for nutrition

Key inclusion criteria (7 listed)

13 years or older
Stable medical condition
Diagnosed with oropharyngeal dysphagia confirmed by Modified Barium Swallow (MBS) baseline measure of the follow two scales:
Folstein Mini-Mental State Examination (MMSE) score of 23 or greater indicating cognitive ability to follow directions and communicate preferences
Willingness to travel to Sentara Rockingham Memorial Hospital 2 or more times to undergo initial evaluation, device use training and checkup at 3 months.

Key exclusion criteria (13 listed)

Pregnancy
Cardiac problems
Highly-pigmented (dark) skin color is an exclusion criterion because near-infrared spectroscopy requires the measurement of the degree of absorption of different wavelengths of light after being reflected back through the scalp. Highly pigmented skin interferes with wavelength transmission, making the measurement of changes in absorption inaccurate.
Lack of a primary care physician who can be contacted if there are findings on the Magnetic Resonance Imaging (MRI) scan.
Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dysphagia retraining with deviceAlso: Passy Muir Swallowing Self TrainerPatients used the device for 60 trials of retraining swallowing at home each day and also had the device turned on throughout the day in automatic mode to intermittently trigger every few minutes to trigger a swallow for saliva control	Device	Dysphagia retraining with device

Primary outcome

Change in Dysphagia Outcome and Severity Scale (DOSS) Rating
Time frame: From before onset of device use to return 3 months later
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
Dysphagia Handicap Index (DHI)
Time frame: From before onset of device use to return 3 months later
Total handicap Score from 0 (no Handicap) to 100 (Severe Handicap)

2 secondary outcomes

Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure
Time frame: From before onset of device use to return 3 months later
Cortical Activation for Swallowing
Time frame: From before onset of device use to return 3 months later

Results and safety

Results posted to the registry on 11 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Laryngeal Vibrotactile Stimulation	11	7

Primary outcome: Change in Dysphagia Outcome and Severity Scale (DOSS) Rating

Time frame: From before onset of device use to return 3 months later. Count of participants. Unit: Participants

Measure	Laryngeal Vibrotactile Stimulation n = 7
No change on DOSS	5
Improvement on DOSS	2

Laryngeal Vibrotactile Stimulation: p <0.025, Wilcoxon (Mann-Whitney)

Population analysed: 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

Primary outcome: Dysphagia Handicap Index (DHI)

Time frame: From before onset of device use to return 3 months later. Mean (Standard Deviation). Unit: units on a scale

Measure	Laryngeal Vibrotactile Stimulation n = 7
Pre Device use DHI score	61.143 (17.199)
Post Use DHI Score	38.571 (22.501)

Laryngeal Vibrotactile Stimulation: Mean Difference (Net): 22.571 (95% CI 6.003 to 39.140), p = 0.016, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laryngeal Vibrotactile Stimulation	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28679839Mulheren RW, Ludlow CL. Vibration over the larynx increases swallowing and cortical activation for swallowing. J Neurophysiol. 2017 Sep 1;118(3):1698-1708. doi: 10.1152/jn.00244.2017. Epub 2017 Jul 5.
Background: PubMed 27471240Hegyi Szynkiewicz S, Mulheren RW, Palmore KW, O'Donoghue CR, Ludlow CL. Using devices to upregulate nonnutritive swallowing in typically developing infants. J Appl Physiol (1985). 2016 Oct 1;121(4):831-837. doi: 10.1152/japplphysiol.00797.2015. Epub 2016 Jul 28.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erin Kamarunas, PhD principal investigator

James Madison University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Brain Injury, run by James Madison University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dysphagia Outcome and Severity Scale (DOSS) Rating (time frame: From before onset of device use to return 3 months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02848664, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.