N/A
Completed N=12
The Passy Muir Swallowing Self Training Device
Oropharyngeal Dysphagia
Source: ClinicalTrials.gov NCT01765673 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Change in Swallow Frequency 30 Hz — 0.512 Change in swallows/min — p=0.218
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Swallow Frequency 30 Hz |
0.512 | 0.218 |
| PRIMARY Change in Swallow Frequency 70 Hz |
0.747 | 0.017 sig |
| PRIMARY Change in Swallow Frequency 110 Hz |
0.849 | 0.022 sig |
| PRIMARY Change in Swallow Frequency 150 Hz |
0.110 | 0.719 |
| PRIMARY Change in Swallowing Frequency 70 & 110 Hz |
0.246 | 0.418 |
| SECONDARY Change in Urge to Swallow After 30 Hz Stimulation |
18.83 | 0.038 sig |
| SECONDARY Change in Urge to Swallow 70 Hz |
13.167 | 0.086 |
| SECONDARY Change in VAS Urge to Swallow 110 Hz |
12.75 | 0.16 |
| SECONDARY Change in VAS Urge to Swallow 150 Hz |
14.75 | 0.052 |
| SECONDARY Change in VAS Urge to Swallow 70 & 110 Hz |
2.273 | 0.827 |
| SECONDARY Change in Discomfort Level 30 Hz |
2.750 | 0.088 |
| SECONDARY Change in Discomfort 70 Hz |
5.25 | 0.152 |
| SECONDARY Change in Discomfort 110 Hz |
4.083 | 0.229 |
| SECONDARY Change in Discomfort 150 Hz |
5.583 | 0.121 |
| SECONDARY Change in Discomfort 70 & 110 Hz |
5.273 | 0.239 |
| SECONDARY Change in Swallowing Frequency 2 kPa |
1.417 | 0.03 sig |
| SECONDARY Change in Swallow Frequency 4 kPa |
2.0 | 0.067 |
| SECONDARY Change in Swallow Frequency 6 kPa |
1.5 | 0.396 |
| SECONDARY Percent Change in Swallow Frequency Pulse vs Continuous |
37.5 | 0.373 |
| SECONDARY Change in Swallow Initiation Time |
372 | 0.744 |
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
Data sourced from ClinicalTrials.gov (NCT01765673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.