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Completed

NCT Number: NCT04766658

A Study to Evaluate Effects of Gargle Phonation in Voice

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.

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Key information

Conditions

Voice Disorders Communication Disorders Laryngeal Diseases Mental Disorders Muscle Tension Dysphonia Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Speech Therapy

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gargle Phonation

Other

Subjects will gargle water while making sound

Water swallow

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Gargle Phonation in Individuals With Muscle Tension Dysphonia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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