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A Study to Evaluate Effects of Gargle Phonation in Voice

Gargle Phonation in Individuals With Muscle Tension Dysphonia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04766658
Enrollment
36
Registered
2021-02-23
Start date
2021-01-29
Completion date
2021-04-15
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Tension Dysphonia, Speech Therapy, Voice Disorders

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).

Interventions

OTHERGargle Phonation

Subjects will gargle water while making sound

OTHERWater swallow

Subjects will hold water in their mouth for 5 seconds and swallow

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Rating of Effort BaselineBaselineMeasured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Rating of Effort Post SwallowAfter water swallow intervention, approximately 5 minutesMeasured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Rating of Effort Post GargleAfter gargle phonation intervention, approximately 5 minutesMeasured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026