A Study to Evaluate Effects of Gargle Phonation in Voice

Study Overview
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Brief Summary
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The purpose of this study is to assess subjects with muscle tension dysphonia for perceived effort and acoustic effects of gargle phonation compared to baseline and a sham water swallow.

Detailed Description
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This study assesses perceived effort following baseline talking, water swallows and gargle phonation. In addition to perceived effort, acoustic and perceptual analyses will be conducted on the recorded voice samples using vowel sounds, the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) and Hearing in Noise Sentences (HINT).

Official Title
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Gargle Phonation in Individuals With Muscle Tension Dysphonia

Conditions
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Voice Disorders, Muscle Tension Dysphonia, Speech Therapy

Intervention / Treatment
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* Other: Gargle Phonation
* Other: Water swallow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a primary or secondary muscle tension dysphonia based clinical assessment with a Mayo clinic speech language pathologist or other Mayo Clinic otolaryngology care provider in Rochester or Phoenix/Scottsdale locations. Age 18 through 89. Able to provide informed consent. Exclusion Criteria: Anyone not meeting inclusion criteria. Anyone unable or unwilling to provide informed consent. Anyone unable to complete questionnaires or participate in voice recording. Anyone with severe neurological voice or speech disorders. Moderate or severe dysphagia for thin liquids. Non-English speakers (English as a second language may be included). Extensive laryngeal surgery or other surgery or medical condition that may significantly alter the motor or sensory aspects of the larynx.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Water Swallow Intervention First<br>Subjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation. | Other: Water swallow<br>* Subjects will hold water in their mouth for 5 seconds and swallow<br>|
| Other: Gargle Phonation Intervention First<br>Subjects will complete voice recordings after gargle phonation and then perform voice recordings after gargle phonation. | Other: Gargle Phonation<br>* Subjects will gargle water while making sound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of Effort Baseline | Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort. | Baseline | 
| Rating of Effort Post Swallow | Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort. | After water swallow intervention, approximately 5 minutes | 
| Rating of Effort Post Gargle | Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort. | After gargle phonation intervention, approximately 5 minutes |