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Completed

NCT Number: NCT01765673

The Passy Muir Swallowing Self Training Device

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).

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Key information

Conditions

Oropharyngeal Dysphagia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

James Madison University and Rockingham Memorial Hospital

Harrisonburg, Virginia, 22801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrotactile Stimulation

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.

Other names: Passy Muir Swallowing Serlf Trainer

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

James Madison University

Other

Collaborators

  • Passy Muir Inc.

Registry information

Official study title

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

Acronym: PMSST

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2013
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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