The Passy Muir Swallowing Self Training Device "PMSST"

Completed

Phase N/A Results

Update History

15 Nov '17
Trial name was updated.
New
The Passy Muir Swallowing Self Training Device
The Summary of Purpose was updated.
New
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).
Old
The purpose of this study is to develop a vibratory self-trainer for the treatment of dysphagia post-stroke. The aim is to identify the optimal stimulation characteristics for use with participants with swallowing problems including: - Frequency of vibration - Mode of vibration either continuous or pulsed - Pressure of device against the neck - Duration of vibration to allow a participant to initiate a swallow
The description was updated.
New
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.
Old
This study investigates the use of self-training device to improve swallowing post-stroke. The device has motors placed on the neck over each side of the thyroid cartilage and provides noninvasive vibratory stimulation. The vibration penetrates through the neck to the tissues in the larynx to activate mechanoreceptors innervated by the internal branch of the superior laryngeal nerve, which when stimulated will trigger swallowing at the brain stem level. The outcomes of this research will be used to develop a device for use by the patients for daily swallowing self-training in their own environment. Site monitoring and auditing will be conducted at crucial time points during the study, including just prior to participant enrollment. Auditing will be conducted by Julie Kobak, Vice President for Clinical Education of Passy Muir , Inc. Source data verification will be comparing raw data forms to electronic case report forms. Standard operating procedures are in place for participant recruitment, data collection, data management, data analysis, and reporting adverse events. Sample size assessment: Based on previous studies in healthy volunteers contrasting air puff stimulation on the rate of swallowing (1, 2) the expected change in rate of swallowing will be from 1.2 swallows/minute without stimulation to 2.0 swallows/minute with stimulation with a standard deviation of the differences being 0.9. Using a Bonferroni corrected alpha of 0.025 (to test 2 measures) at 0.80 power with an effect size of 0.88, the number of participants needed will be 15 per experiment. Allowing for some participants to participate in several studies, the investigators plan to recruit between 30 and 40 participants with risk of aspiration post stroke. Potential problems and alternative strategies: Anticipated problems include difficulties with recruiting an adequate sample. There are 3 rooms available for participant testing at Rockingham Memorial Hospital to support multiple participants being tested simultaneously. Furthermore, all the equipment is portable including Powerlab, a laptop, the amplifier system, the Kistler accelerometers, and Inductive plethysmography so participants can be tested in rehabilitation settings and/or in their own home. Advertisements and a website have also been created.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - Stroke - 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: - Head injury - Head and neck cancer - 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
24 Feb '16
The description was updated.
New
This study investigates the use of self-training device to improve swallowing post-stroke. The device has motors placed on the neck over each side of the thyroid cartilage and provides noninvasive vibratory stimulation. The vibration penetrates through the neck to the tissues in the larynx to activate mechanoreceptors innervated by the internal branch of the superior laryngeal nerve, which when stimulated will trigger swallowing at the brain stem level. The outcomes of this research will be used to develop a device for use by the patients for daily swallowing self-training in their own environment. Site monitoring and auditing will be conducted at crucial time points during the study, including just prior to participant enrollment. Auditing will be conducted by Julie Kobak, Vice President for Clinical Education of Passy Muir , Inc. Source data verification will be comparing raw data forms to electronic case report forms. Standard operating procedures are in place for participant recruitment, data collection, data management, data analysis, and reporting adverse events. Sample size assessment: Based on previous studies in healthy volunteers contrasting air puff stimulation on the rate of swallowing (1, 2) the expected change in rate of swallowing will be from 1.2 swallows/minute without stimulation to 2.0 swallows/minute with stimulation with a standard deviation of the differences being 0.9. Using a Bonferroni corrected alpha of 0.025 (to test 2 measures) at 0.80 power with an effect size of 0.88, the number of participants needed will be 15 per experiment. Allowing for some participants to participate in several studies, the investigators plan to recruit between 30 and 40 participants with risk of aspiration post stroke. Potential problems and alternative strategies: Anticipated problems include difficulties with recruiting an adequate sample. There are 3 rooms available for participant testing at Rockingham Memorial Hospital to support multiple participants being tested simultaneously. Furthermore, all the equipment is portable including Powerlab, a laptop, the amplifier system, the Kistler accelerometers, and Inductive plethysmography so participants can be tested in rehabilitation settings and/or in their own home. Advertisements and a website have also been created.
Old
This study investigates the use of self-training device to improve swallowing post-stroke. The device has motors placed on the neck over each side of the thyroid cartilage and provides noninvasive vibratory stimulation. The vibration penetrates through the neck to the tissues in the larynx to activate mechanoreceptors innervated by the internal branch of the superior laryngeal nerve, which when stimulated will trigger swallowing at the brain stem level. The outcomes of this research will be used to develop a device for use by the patients for daily swallowing self-training in their own environment. Site monitoring and auditing will be conducted at crucial time points during the study, including just prior to participant enrollment. Auditing will be conducted by Julie Kobak, Vice President for Clinical Education of Passy Muir , Inc. Source data verification will be comparing raw data forms to electronic case report forms. Standard operating procedures are in place for participant recruitment, data collection, data management, data analysis, and reporting adverse events. Sample size assessment: Based on previous studies in healthy volunteers contrasting air puff stimulation on the rate of swallowing (1, 2) the expected change in rate of swallowing will be from 1.2 swallows/minute without stimulation to 2.0 swallows/minute with stimulation with a standard deviation of the differences being 0.9. Using a Bonferroni corrected alpha of 0.025 (to test 2 measures) at 0.80 power with an effect size of 0.88, the number of participants needed will be 15 per experiment. Allowing for some participants to participate in several studies, the investigators plan to recruit between 30 and 40 participants with risk of aspiration post stroke. Potential problems and alternative strategies: Anticipated problems include difficulties with recruiting an adequate sample. There are 3 rooms available for participant testing at Rockingham Memorial Hospital to support multiple participants being tested simultaneously. Furthermore, all the equipment is portable including Powerlab, a laptop, the amplifier system, the Kistler accelerometers, and Inductive plethysmography so participants can be tested in rehabilitation settings and/or in their own home. Advertisements and a website have also been created.
A location was updated in Harrisonburg.
New
The overall status was removed for James Madison University and Rockingham Memorial Hospital.
5 Feb '13
A location was updated in Harrisonburg.
New
The overall status was removed for James Madison University and Rockingham Memorial Hospital.
12 Jan '13
The Summary of Purpose was updated.
New
The purpose of this study is to develop a vibratory self-trainer for the treatment of dysphagia post-stroke. The aim is to identify the optimal stimulation characteristics for use with participants with swallowing problems including: - Frequency of vibration - Mode of vibration either continuous or pulsed - Pressure of device against the neck - Duration of vibration to allow a participant to initiate a swallow
Old
The purpose of this study is to develop a vibratory self-trainer for the treatment of dysphagia post-stroke. The aim is to identify the optimal stimulation characteristics for use with participants with swallowing problems including: - Frequency of vibration - Mode of vibration either continuous or pulsed - Pressure of device against the neck - Duration of vibration to allow a participant to initiate a swallow The second aim will determine the optimum time points post stroke for introducing the new treatment system to patients. Input from speech pathologists active in the management of dysphagia will be obtained using two approaches: - Focus groups at professional meetings to gather opinions on the optimal time points for training patients and their caregivers on device use. - Conducting webinars to introduce the device and then administer a survey to gather options on optimal delivery and training time points.
The description was updated.
New
This study investigates the use of self-training device to improve swallowing post-stroke. The device has motors placed on the neck over each side of the thyroid cartilage and provides noninvasive vibratory stimulation. The vibration penetrates through the neck to the tissues in the larynx to activate mechanoreceptors innervated by the internal branch of the superior laryngeal nerve, which when stimulated will trigger swallowing at the brain stem level. The outcomes of this research will be used to develop a device for use by the patients for daily swallowing self-training in their own environment. Site monitoring and auditing will be conducted at crucial time points during the study, including just prior to participant enrollment. Auditing will be conducted by Julie Kobak, Vice President for Clinical Education of Passy Muir , Inc. Source data verification will be comparing raw data forms to electronic case report forms. Standard operating procedures are in place for participant recruitment, data collection, data management, data analysis, and reporting adverse events. Sample size assessment: Based on previous studies in healthy volunteers contrasting air puff stimulation on the rate of swallowing (1, 2) the expected change in rate of swallowing will be from 1.2 swallows/minute without stimulation to 2.0 swallows/minute with stimulation with a standard deviation of the differences being 0.9. Using a Bonferroni corrected alpha of 0.025 (to test 2 measures) at 0.80 power with an effect size of 0.88, the number of participants needed will be 15 per experiment. Allowing for some participants to participate in several studies, the investigators plan to recruit between 30 and 40 participants with risk of aspiration post stroke. Potential problems and alternative strategies: Anticipated problems include difficulties with recruiting an adequate sample. There are 3 rooms available for participant testing at Rockingham Memorial Hospital to support multiple participants being tested simultaneously. Furthermore, all the equipment is portable including Powerlab, a laptop, the amplifier system, the Kistler accelerometers, and Inductive plethysmography so participants can be tested in rehabilitation settings and/or in their own home. Advertisements and a website have also been created.
Old
This study investigates the use of self-training device to improve swallowing post-stroke. The device has motors placed on the neck over each side of the thyroid cartilage and provides noninvasive vibratory stimulation. The vibration penetrates through the neck to the tissues in the larynx to activate mechanoreceptors innervated by the internal branch of the superior laryngeal nerve, which when stimulated will trigger swallowing at the brain stem level. The outcomes of this research will be used to develop a device for use by the patients for daily swallowing self-training in their own environment. Site monitoring and auditing will be conducted at crucial time points during the study, including just prior to participant enrollment. Auditing will be conducted by Julie Kobak, Vice President for Clinical Education of Passy Muir , Inc. Source data verification will be comparing raw data forms to electronic case report forms. Standard operating procedures are in place for participant recruitment, data collection, data management, data analysis, and reporting adverse events. Sample size assessment: Based on previous studies in healthy volunteers contrasting air puff stimulation on the rate of swallowing by Theurer et al. (2005, 2009), the expected change in rate of swallowing will be from 1.2 swallows/minute without stimulation to 2.0 swallows/minute with stimulation with a standard deviation of the differences being 0.9. Using a Bonferroni corrected alpha of 0.025 (to test 2 measures) at 0.80 power with an effect size of 0.88, the number of participants needed will be 15 per experiment. Allowing for some participants to participate in several studies, we plan to recruit between 30 and 40 participants with risk of aspiration post stroke to participate in Aim 1. Potential problems and alternative strategies: Anticipated problems include difficulties with recruiting an adequate sample. We have 3 rooms available for participant testing at Rockingham Memorial Hospital to support multiple participants being tested simultaneously. Furthermore, all the equipment is portable including Powerlab, a laptop, the amplifier system, the Kistler accelerometers, and Inductive plethysmography so we can also test participants in rehabilitation settings and/or in their own home. Advertisements and a website have also been created.