A Study to Evaluate Effects of Gargle Phonation in Voice

Not Applicable

Completed

• Conditions: Voice Disorders; Muscle Tension Dysphonia; Speech Therapy
• Interventions: Other: Water swallow; Other: Gargle Phonation

• Registration Number: NCT04766658
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-01-29
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-23
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Water Swallow Intervention First	Water swallow	Subjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation.
Gargle Phonation Intervention First	Gargle Phonation	Subjects will complete voice recordings after gargle phonation and then perform voice recordings after gargle phonation.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States