A Study to Evaluate Effects of Gargle Phonation in Voice

NCT ID: NCT04766658

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2021-04-15

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).

Conditions

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Voice Disorders Muscle Tension Dysphonia Speech Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Water Swallow Intervention First

Subjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation.

Group Type OTHER

Water swallow

Intervention Type OTHER

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

Gargle Phonation Intervention First

Subjects will complete voice recordings after gargle phonation and then perform voice recordings after gargle phonation.

Group Type OTHER

Gargle Phonation

Intervention Type OTHER

Subjects will gargle water while making sound

Interventions

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Gargle Phonation

Subjects will gargle water while making sound

Intervention Type OTHER

Water swallow

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

Intervention Type OTHER

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.

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Diana M. Orbelo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diana M Orbelo, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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20-004267

Identifier Type: -

Identifier Source: org_study_id

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