A Study to Evaluate Effects of Gargle Phonation in Voice

NCT04766658 | Completed

• 1 other identifier: 20-004267
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Voice Disorders; Muscle Tension Dysphonia; Speech Therapy

Outcome Measures

Primary Outcomes (3)

• Rating of Effort Baseline

  Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.

  Baseline

• 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

• 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

Study Arms (2)

Water Swallow Intervention First

OTHER

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

Other: Water swallow

Gargle Phonation Intervention First

OTHER

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

Other: Gargle Phonation

Interventions

Gargle Phonation OTHER

Subjects will gargle water while making sound

Gargle Phonation Intervention First

Water swallow OTHER

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

Water Swallow Intervention First

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Voice Disorders; Communication Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Diana M Orbelo, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 23, 2021
• Study Start: January 29, 2021
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

US (2)