Back to resultsA Study to Evaluate Effects of Gargle Phonation in Voice
Primary Purpose
Voice Disorders, Muscle Tension Dysphonia, Speech Therapy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gargle Phonation
Water swallow
Sponsored by
About this trial
This is an interventional treatment trial for Voice Disorders
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Arizona
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Water Swallow Intervention First
Gargle Phonation Intervention First
Arm Description
Subjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation.
Subjects will complete voice recordings after gargle phonation and then perform voice recordings after gargle phonation.
Outcomes
Primary Outcome Measures
Rating of Effort Baseline
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Rating of Effort Post Swallow
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Rating of Effort Post Gargle
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04766658
Brief Title
A Study to Evaluate Effects of Gargle Phonation in Voice
Official Title
Gargle Phonation in Individuals With Muscle Tension Dysphonia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Disorders, Muscle Tension Dysphonia, Speech Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water Swallow Intervention First
Arm Type
Other
Arm Description
Subjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation.
Arm Title
Gargle Phonation Intervention First
Arm Type
Other
Arm Description
Subjects will complete voice recordings after gargle phonation and then perform voice recordings after gargle phonation.
Intervention Type
Other
Intervention Name(s)
Gargle Phonation
Intervention Description
Subjects will gargle water while making sound
Intervention Type
Other
Intervention Name(s)
Water swallow
Intervention Description
Subjects will hold water in their mouth for 5 seconds and swallow
Primary Outcome Measure Information:
Title
Rating of Effort Baseline
Description
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Time Frame
Baseline
Title
Rating of Effort Post Swallow
Description
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Time Frame
After water swallow intervention, approximately 5 minutes
Title
Rating of Effort Post Gargle
Description
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Time Frame
After gargle phonation intervention, approximately 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana M Orbelo, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate Effects of Gargle Phonation in Voice
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