A Study to Evaluate Effects of Gargle Phonation in Voice

October 17, 2022 updated by: Diana M. Orbelo, Mayo Clinic

Gargle Phonation in Individuals With Muscle Tension Dysphonia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rating of Effort Baseline
Time Frame: 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
Time Frame: 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.
After water swallow intervention, approximately 5 minutes
Rating of Effort Post Gargle
Time Frame: 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.
After gargle phonation intervention, approximately 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Diana M Orbelo, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2021

Primary Completion (ACTUAL)

April 15, 2021

Study Completion (ACTUAL)

April 15, 2021

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (ACTUAL)

February 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-004267

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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