A Study to Evaluate Effects of Gargle Phonation in Voice

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04766658
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 18
• Patients Per Site: 100
• Patients Per Site Per Month: 5.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Voice Disorders; Muscle Tension Dysphonia; Speech Therapy	Other: Gargle Phonation; Other: Water swallow	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Gargle Phonation in Individuals With Muscle Tension Dysphonia
• Actual Study Start Date: Jan 29, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rating of Effort Baseline [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Diana M. Orbelo, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04766658
• Other Study ID Numbers: 20-004267
• First Posted: Feb 23, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dysphonia; Hoarseness; Voice Disorders; Communication Disorders

Study Results

No Results Posted as of Apr 6, 2022