An interventional study of Gargle Phonation and Water swallow in Voice Disorders, Muscle Tension Dysphonia and Speech Therapy, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-19.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
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).
77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.
This study's enrollment of 36 is below the median of 41 across 54 interventional studies indexed under Voice Disorders.
Browse Voice Disorders studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation.
Other: Water swallow
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
Subjects will hold water in their mouth for 5 seconds and swallow
Rating of Effort Baseline
Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.
Time frame: Baseline
Rating of Effort Post Swallow
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
Rating of Effort Post Gargle
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
Ran from Jan 2021 to primary completion in Apr 2021, 2 months.
Of 30 interventional studies with no phase under Voice Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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