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Use of the Passy Muir Swallowing Self Trainer

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ClinicalTrials.gov Identifier: NCT02848664
Recruitment Status : Completed
First Posted : July 28, 2016
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Passy Muir Inc.
Information provided by (Responsible Party):
Christy Ludlow, James Madison University

Brief Summary:
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.

Condition or disease Intervention/treatment
Stroke Brain Injury Head and Neck Cancer Device: Dysphagia retraining with device

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:

  1. To develop and evaluate training for participants and caregivers to use the self-trainer.
  2. To gather participant feedback on the use of the device after 3 months of daily practice.
  3. 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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia
Actual Study Start Date : August 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Device: Dysphagia retraining with device
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
Other Name: Passy Muir Swallowing Self Trainer




Primary Outcome Measures :
  1. 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


  2. 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)


Secondary Outcome Measures :
  1. Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure [ Time Frame: From before onset of device use to return 3 months later ]
    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.

  2. Cortical Activation for Swallowing [ Time Frame: From before onset of device use to return 3 months later ]
    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.



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Ages Eligible for Study:   13 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic severe dysphagia requiring Percutaneous Endoscopic Gastrostomy (PEG) tube for nutrition
Criteria

Inclusion Criteria:

  • 13 years or older
  • Stable medical condition
  • Diagnosed with oropharyngeal dysphagia confirmed by Modified Barium Swallow (MBS) baseline measure of the follow two scales:

    1. Penetration-Aspiration Scale score of 2 or greater verified by modified barium swallow (Rosenbek et al., 1996) and/or
    2. 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.

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848664


Locations
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United States, Virginia
James Madison University
Harrisonburg, Virginia, United States, 22807
Sponsors and Collaborators
James Madison University
Passy Muir Inc.
Investigators
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Principal Investigator: Erin Kamarunas, PhD James Madison University
  Study Documents (Full-Text)

Documents provided by Christy Ludlow, James Madison University:
Study Protocol  [PDF] July 29, 2015
Informed Consent Form  [PDF] June 13, 2014


Publications:
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Responsible Party: Christy Ludlow, Professor, James Madison University
ClinicalTrials.gov Identifier: NCT02848664     History of Changes
Other Study ID Numbers: #14-0064
First Posted: July 28, 2016    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries