A Study to Evaluate Effects of Gargle Phonation in Voice

Voice Disorders Clinical Trial

Official title:

Gargle Phonation in Individuals With Muscle Tension Dysphonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766658
• Other study ID #: 20-004267
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: April 15, 2021

Study information

• Verified date: October 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communication Disorders
• Dysphonia
• Hoarseness
• Muscle Tension Dysphonia
• Speech Therapy
• Voice Disorders

Intervention

Other:
• Gargle Phonation
Subjects will gargle water while making sound
• Water swallow
Subjects will hold water in their mouth for 5 seconds and swallow

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of Effort Baseline	Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.	Baseline
Primary	Rating of Effort Post Swallow	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
Primary	Rating of Effort Post Gargle	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

External Links

•   Mayo Clinic Clinical Trials