Clinical trial NCT01765673: The Passy Muir Swallowing Self Training Device
Official title: Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Dysphagia
Keywords: Swallowing
Stroke
Sensory stimulation
Home based therapy
Head and Neck Cancer
Lead sponsor: James Madison University
Sponsor class: OTHER
Collaborators: name: Passy Muir Inc.
First posted: 2013-01-10
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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).

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 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

Primary outcomes:
measure: Change in Swallow Frequency 30 Hz
timeFrame: During one session within 1 hour
measure: Change in Swallow Frequency 70 Hz
timeFrame: During one session within 1 hour
measure: Change in Swallow Frequency 110 Hz
timeFrame: During one session within 1 hour
measure: Change in Swallow Frequency 150 Hz
timeFrame: During one session within 1 hour
measure: Change in Swallowing Frequency 70 & 110 Hz
timeFrame: During one session within 1 hour
Secondary outcomes:
measure: Change in Urge to Swallow After 30 Hz Stimulation
timeFrame: During one session within 1 hour
measure: Change in Urge to Swallow 70 Hz
timeFrame: During one session within 1 hour
measure: Change in VAS Urge to Swallow 110 Hz
timeFrame: During one session within 1 hour
measure: Change in VAS Urge to Swallow 150 Hz
timeFrame: During one session within 1 hour
measure: Change in VAS Urge to Swallow 70 & 110 Hz
timeFrame: During one session within 1 hour
measure: Change in Discomfort Level 30 Hz
timeFrame: During one session within 1 hour
measure: Change in Discomfort 70 Hz
timeFrame: During one session within 1 hour
measure: Change in Discomfort 110 Hz
timeFrame: During one session within 1 hour
measure: Change in Discomfort 150 Hz
timeFrame: During one session within 1 hour
measure: Change in Discomfort 70 & 110 Hz
timeFrame: During one session within 1 hour
measure: Change in Swallowing Frequency 2 kPa
timeFrame: During one session within 1 hour
measure: Change in Swallow Frequency 4 kPa
timeFrame: During one session within 1 hour
measure: Change in Swallow Frequency 6 kPa
timeFrame: During one session within 1 hour
measure: Percent Change in Swallow Frequency Pulse vs Continuous
timeFrame: During one session within one hour
measure: Change in Swallow Initiation Time
timeFrame: During one session within 1 hour
Other outcomes:
Locations:
city: Harrisonburg
country: United States
facility: James Madison University and Rockingham Memorial Hospital
state: Virginia
Study officials:
affiliation: James Madison University
name: Christy L Ludlow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.