Oropharyngeal DysphagiaPMSSTNCT01765673
The Passy Muir Swallowing Self Training Device
An observational study of Oropharyngeal Dysphagia, run by James Madison University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- Vibrotactile stimulation
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 22 Feb 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have swallowing problems secondary to a stroke or following radiation for the treatment of head and neck cancer
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
James Madison University and Rockingham Memorial Hospital
Harrisonburg, Virginia, 22801
About this study
Official title: Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke
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).
Read the 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.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- Vibrotactile stimulation
- Keywords
- Swallowing, Stroke, Sensory stimulation, Home based therapy, Head and Neck Cancer
- Medical subject headings
- Deglutition Disorders, Stroke, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile stimulationDevice
Also called Passy Muir Swallowing Serlf Trainer
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vibrotactile stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During one session within 1 hour
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)
Measured: During one session within 1 hour
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)
Measured: During one session within 1 hour
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)
Measured: During one session within 1 hour
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)
Measured: During one session within 1 hour
Secondary outcomes (15)
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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.
Measured: During one session within 1 hour
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
Measured: During one session within 1 hour
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
Measured: During one session within 1 hour
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
Measured: During one session within 1 hour
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
Measured: During one session within one hour
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
Measured: During one session within 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study start1 Jan 2013
- Primary completion22 Feb 2016
- Study completion22 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Madison University
- Sponsor type
- University, hospital or other
- Collaborators
- Passy Muir Inc.
- Responsible party
- Principal investigator, Christy Ludlow, James Madison University
- Investigators
- Christy L Ludlow, PhD, Principal investigator, James Madison University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765673
- Sponsor's protocol ID
- R43DC012754
- Acronym
- PMSST
- Status last verified
- Sep 2017
- First submitted
- 8 Jan 2013
- Last updated
- 14 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16633868Theurer 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.
PubMed 19390893
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke
- ClinicalTrials.gov ID
- NCT01765673
- Acronym / sponsor ID
- PMSST / R43DC012754
- Conditions
- Oropharyngeal Dysphagia
- Keywords
- Swallowing, Stroke, Sensory stimulation, Home based therapy, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- James Madison UniversityUniversity, hospital or other
- Collaborators
- Passy Muir Inc.
- Study start
- 1 Jan 2013
- Primary completion
- 22 Feb 2016 (actual)
- Study completion
- 22 Feb 2016 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 14 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Stimulation in Dysphagia | – | Device: Vibrotactile stimulationA 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have swallowing problems secondary to a stroke or following radiation for the treatment of head and neck cancer
Key inclusion criteria (2 listed)
- 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"
Key exclusion criteria (8 listed)
- Neck injury
- Epilepsy
- Neurological disorder other than stroke
- Psychiatric illness other than depression
- Uncontrolled gastroesophageal reflux disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrotactile stimulationAlso: Passy Muir Swallowing Serlf TrainerComparison 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. | Device | Vibrotactile Stimulation in Dysphagia |
Primary outcome
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)
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)
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)
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)
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)
15 secondary outcomes
Change in Urge to Swallow After 30 Hz Stimulation
Time frame: During one session within 1 hour
Change in Urge to Swallow 70 Hz
Time frame: During one session within 1 hour
Change in VAS Urge to Swallow 110 Hz
Time frame: During one session within 1 hour
Change in VAS Urge to Swallow 150 Hz
Time frame: During one session within 1 hour
Change in VAS Urge to Swallow 70 & 110 Hz
Time frame: During one session within 1 hour
Change in Discomfort Level 30 Hz
Time frame: During one session within 1 hour
Change in Discomfort 70 Hz
Time frame: During one session within 1 hour
Change in Discomfort 110 Hz
Time frame: During one session within 1 hour
Change in Discomfort 150 Hz
Time frame: During one session within 1 hour
Change in Discomfort 70 & 110 Hz
Time frame: During one session within 1 hour
Change in Swallowing Frequency 2 kPa
Time frame: During one session within 1 hour
Change in Swallow Frequency 4 kPa
Time frame: During one session within 1 hour
Change in Swallow Frequency 6 kPa
Time frame: During one session within 1 hour
Percent Change in Swallow Frequency Pulse vs Continuous
Time frame: During one session within one hour
Change in Swallow Initiation Time
Time frame: During one session within 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16633868Theurer 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.
- Results publication: PubMed 19390893Theurer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christy L Ludlow, PhD principal investigator
James Madison University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Dysphagia, run by James Madison University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Swallow Frequency 30 Hz (time frame: During one session within 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01765673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.