Voice DisordersNCT04766658
A Study to Evaluate Effects of Gargle Phonation in Voice
A study testing Gargle Phonation and Water swallow in people with Voice Disorders and Muscle Tension Dysphonia, run by Mayo Clinic at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders, Muscle Tension Dysphonia, Speech Therapy
- What is being tested?
- Gargle Phonation and Water swallow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2021to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Gargle Phonation in Individuals With Muscle Tension Dysphonia
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.
Read the 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).
- Conditions
- Voice Disorders, Muscle Tension Dysphonia, Speech Therapy
- Being tested
- Gargle Phonation, Water swallow
- Medical subject headings
- Voice Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gargle PhonationOther
Subjects will gargle water while making sound
Water swallowOther
Subjects will hold water in their mouth for 5 seconds and swallow
| Study group | Role | What they receive |
|---|---|---|
| Water Swallow Intervention First | Other | Subjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation. Receives: Other: Water swallow |
| Gargle Phonation Intervention First | Other | Subjects will complete voice recordings after gargle phonation and then perform voice recordings after gargle phonation. Receives: Other: Gargle Phonation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of Effort Baseline
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Measured: Baseline
Rating of Effort Post Swallow
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Measured: 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.
Measured: After gargle phonation intervention, approximately 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start29 Jan 2021
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana M. Orbelo, Mayo Clinic
- Investigators
- Diana M Orbelo, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766658
- Sponsor's protocol ID
- 20-004267
- Status last verified
- Oct 2022
- First submitted
- 29 Jan 2021
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gargle Phonation in Individuals With Muscle Tension Dysphonia
- ClinicalTrials.gov ID
- NCT04766658
- Acronym / sponsor ID
- 20-004267
- Conditions
- Voice Disorders, Muscle Tension Dysphonia, Speech Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water Swallow Intervention First | Other | Other: Water swallowSubjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation. |
| Gargle Phonation Intervention First | Other | Other: Gargle PhonationSubjects will complete voice recordings after gargle phonation and then perform voice recordings after gargle phonation. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gargle PhonationSubjects will gargle water while making sound | Other | Gargle Phonation Intervention First |
| Water swallowSubjects will hold water in their mouth for 5 seconds and swallow | Other | Water Swallow Intervention First |
Primary outcome
Rating of Effort Baseline
Time frame: Baseline
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Rating of Effort Post Swallow
Time frame: 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.
Rating of Effort Post Gargle
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana M Orbelo, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gargle Phonation and Water swallow in people with Voice Disorders and Muscle Tension Dysphonia, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating of Effort Baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.