The Passy Muir Swallowing Self Training Device

Oropharyngeal Dysphagia Clinical Trial

— PMSST  

Official title:

Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765673
• Other study ID #: R43DC012754
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: October 17, 2017
• Start date: January 1, 2013
• Est. completion date: February 22, 2016

Study information

• Verified date: September 2017
• Source: James Madison University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 22, 2016
• Est. primary completion date: February 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Oropharyngeal Dysphagia

Intervention

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.

Locations

Country	Name	City	State
United States	James Madison University and Rockingham Memorial Hospital	Harrisonburg	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
James Madison University	Passy Muir Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Swallow Frequency 30 Hz	Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)	During one session within 1 hour
Primary	Change in Swallow Frequency 70 Hz	Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)	During one session within 1 hour
Primary	Change in Swallow Frequency 110 Hz	Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)	During one session within 1 hour
Primary	Change in Swallow Frequency 150 Hz	Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)	During one session within 1 hour
Primary	Change in Swallowing Frequency 70 & 110 Hz	Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)	During one session within 1 hour
Secondary	Change in Urge to Swallow After 30 Hz Stimulation	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.	During one session within 1 hour
Secondary	Change in Urge to Swallow 70 Hz	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.	During one session within 1 hour
Secondary	Change in VAS Urge to Swallow 110 Hz	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.	During one session within 1 hour
Secondary	Change in VAS Urge to Swallow 150 Hz	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.	During one session within 1 hour
Secondary	Change in VAS Urge to Swallow 70 & 110 Hz	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.	During one session within 1 hour
Secondary	Change in Discomfort Level 30 Hz	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.	During one session within 1 hour
Secondary	Change in Discomfort 70 Hz	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.	During one session within 1 hour
Secondary	Change in Discomfort 110 Hz	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.	During one session within 1 hour
Secondary	Change in Discomfort 150 Hz	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.	During one session within 1 hour
Secondary	Change in Discomfort 70 & 110 Hz	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.	During one session within 1 hour
Secondary	Change in Swallowing Frequency 2 kPa	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	During one session within 1 hour
Secondary	Change in Swallow Frequency 4 kPa	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	During one session within 1 hour
Secondary	Change in Swallow Frequency 6 kPa	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	During one session within 1 hour
Secondary	Percent Change in Swallow Frequency Pulse vs Continuous	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	During one session within one hour
Secondary	Change in Swallow Initiation Time	Change in swallow initiation time (ms) from swallow reaction time during vibrotactile stimulation minus reaction time with sham (no) stimulation	During one session within 1 hour