N/A N=12

The Passy Muir Swallowing Self Training Device

Oropharyngeal Dysphagia

Bottom Line

View on ClinicalTrials.gov: NCT01765673 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: Change in Swallow Frequency 30 Hz — 0.512 Change in swallows/min — p=0.218

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Vibrotactile stimulation (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: James Madison University
Primary completion: Feb 2016

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

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).

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

View full record on ClinicalTrials.gov →

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.