Use of the Passy Muir Swallowing Self Trainer

NCT02848664 | Completed Results DMC

• 1 other identifier: #14-0064
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Brain Injury; Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  From before onset of device use to return 3 months later

Secondary Outcomes (2)

• Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure

  From before onset of device use to return 3 months later

• Cortical Activation for Swallowing

  From before onset of device use to return 3 months later

Study Arms (1)

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

Interventions

Dysphagia retraining with device 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

Also known as: Passy Muir Swallowing Self Trainer

Dysphagia retraining with device

Eligibility Criteria

• Age: 13 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Cardiac problems
• history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia)
• cardiac pacemaker in place
• 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

Sponsors & Collaborators

• James Madison University: lead
• Passy Muir Inc.: collaborator

Study Sites (1)

James Madison University

Harrisonburg, Virginia, 22807, United States

Location

Related Publications (2)

• 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.

  PMID: 28679839 BACKGROUND

• 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.

  PMID: 27471240 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr. Erin Kamarunas
• Organization: James Madison University

kamaruee@jmu.edu

540-568-8846

Study Officials

• Erin Kamarunas, PhD

  James Madison University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 11, 2019
• Results First Posted: March 11, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)