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The Passy Muir Swallowing Self Training Device (PMSST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765673
First Posted: January 10, 2013
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Passy Muir Inc.
Information provided by (Responsible Party):
Christy Ludlow, James Madison University
  Purpose
This is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).

Condition Intervention
Oropharyngeal Dysphagia Device: Vibrotactile stimulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke

Resource links provided by NLM:


Further study details as provided by Christy Ludlow, James Madison University:

Primary Outcome Measures:
  • Change in Swallow Frequency 30 Hz [ Time Frame: 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)

  • Change in Swallow Frequency 70 Hz [ Time Frame: 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)

  • Change in Swallow Frequency 110 Hz [ Time Frame: 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)

  • Change in Swallow Frequency 150 Hz [ Time Frame: 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)

  • Change in Swallowing Frequency 70 & 110 Hz [ Time Frame: 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)


Secondary Outcome Measures:
  • Change in Urge to Swallow After 30 Hz Stimulation [ Time Frame: 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.

  • Change in Urge to Swallow 70 Hz [ Time Frame: 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.

  • Change in VAS Urge to Swallow 110 Hz [ Time Frame: 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.

  • Change in VAS Urge to Swallow 150 Hz [ Time Frame: 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.

  • Change in VAS Urge to Swallow 70 & 110 Hz [ Time Frame: 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.

  • Change in Discomfort Level 30 Hz [ Time Frame: 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.

  • Change in Discomfort 70 Hz [ Time Frame: 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.

  • Change in Discomfort 110 Hz [ Time Frame: 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.

  • Change in Discomfort 150 Hz [ Time Frame: 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.

  • Change in Discomfort 70 & 110 Hz [ Time Frame: 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.

  • Change in Swallowing Frequency 2 kPa [ Time Frame: 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

  • Change in Swallow Frequency 4 kPa [ Time Frame: 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

  • Change in Swallow Frequency 6 kPa [ Time Frame: 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

  • Percent Change in Swallow Frequency Pulse vs Continuous [ Time Frame: 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

  • Change in Swallow Initiation Time [ Time Frame: 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


Enrollment: 13
Study Start Date: January 1, 2013
Study Completion Date: February 22, 2016
Primary Completion Date: February 22, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Device: 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.
Other Name: Passy Muir Swallowing Serlf Trainer

Detailed Description:
Participants were recruited who had chronic moderate to severe dysphagia following stroke or radiation treatment for head and neck cancer. Their frequency of swallowing was transduced with an accelerometer placed on the skin over the thyroid cartilage and inductive plethysmography bands placed over the rib cage and abdomen. When laryngeal elevation coincided with respiratory apnea a swallow was marked. Five different motor frequencies were evaluated to determine their effect on participants frequency of swallowing (swallows per minute). Frequencies were 30, 70, 110, and 150 Hz and a combination of 70 and 110 Hz. For each vibratory frequency the number of swallows per minute occurring during stimulation was compared with sham when the participant was wearing the device but the motor was not turned on. The frequency fo swallowing during stimulation was compared with the frequency of swallowing between stimulations. Visual analogue ratings of the urge to swallow and discomfort were also measured after each condition. Other parameters were the pressure between the motor and the skin (0, 2, 4, and 6 kPa) and swallow initiation time when stimulation was on and when it was not. Swallowing frequency with continuous versus pulsed stimulation was also compared.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who have swallowing problems secondary to a stroke or following radiation for the treatment of head and neck cancer
Criteria

Inclusion Criteria:

  • Stroke or post radiation for the treatment of head and neck cancer
  • Dysphagia with a score of 2 or greater on the Penetration/Aspiration Scale OR a Mann Assessment of Swallowing Ability ordinal risk rating of "probable" or "definite"

Exclusion Criteria:

  • Neck injury
  • Epilepsy
  • Neurological disorder other than stroke
  • Psychiatric illness other than depression
  • Uncontrolled gastroesophageal reflux disease
  • Inability to communicate secondary to significant speech or language problems
  • Inability to maintain alertness for 1 hour
  • Significant health concerns that would put the participant at risk
  Contacts and Locations
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): NCT01765673


Locations
United States, Virginia
James Madison University and Rockingham Memorial Hospital
Harrisonburg, Virginia, United States, 22801
Sponsors and Collaborators
James Madison University
Passy Muir Inc.
Investigators
Principal Investigator: Christy L Ludlow, PhD James Madison University
  Study Documents (Full-Text)

Documents provided by Christy Ludlow, James Madison University:
Informed Consent Form  [PDF] September 16, 2017
Study Protocol  [PDF] October 17, 2017

  More Information

Publications:
Responsible Party: Christy Ludlow, Professor, James Madison University
ClinicalTrials.gov Identifier: NCT01765673     History of Changes
Other Study ID Numbers: R43DC012754 ( U.S. NIH Grant/Contract )
First Submitted: January 8, 2013
First Posted: January 10, 2013
Results First Submitted: May 20, 2017
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christy Ludlow, James Madison University:
Swallowing
Stroke
Sensory stimulation
Home based therapy
Head and Neck Cancer

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases