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The Passy Muir Swallowing Self Training Device

NCT ID: NCT01765673

Last Updated: 2017-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2016-02-22

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Oropharyngeal Dysphagia

Keywords

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Swallowing Stroke Sensory stimulation Home based therapy Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Vibrotactile stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Passy Muir Swallowing Serlf Trainer

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Passy Muir Inc.

INDUSTRY

Sponsor Role collaborator

James Madison University

OTHER

Sponsor Role lead

Responsible Party

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Christy Ludlow

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christy L Ludlow, PhD

Role: PRINCIPAL_INVESTIGATOR

James Madison University

Locations

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James Madison University and Rockingham Memorial Hospital

Harrisonburg, Virginia, United States

Site Status

Countries

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United States

References

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Theurer JA, Bihari F, Barr AM, Martin RE. Oropharyngeal stimulation with air-pulse trains increases swallowing frequency in healthy adults. Dysphagia. 2005 Fall;20(4):254-60. doi: 10.1007/s00455-005-0021-1.

Reference Type RESULT
PMID: 16633868 (View on PubMed)

Theurer JA, Czachorowski KA, Martin LP, Martin RE. Effects of oropharyngeal air-pulse stimulation on swallowing in healthy older adults. Dysphagia. 2009 Sep;24(3):302-13. doi: 10.1007/s00455-009-9207-2. Epub 2009 Apr 24.

Reference Type RESULT
PMID: 19390893 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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R43DC012754

Identifier Type: NIH

Identifier Source: org_study_id

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