Translaryngeal Vibration for Hyperfunctional Voice Disorders
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTexas Christian University
About this trial
Contemporary treatments for hyperfunctional voice disorders such as muscle tension dysphonia (MTD) are effective but typically do not restore voice handicap or voice function to normal thresholds. Recent reports of vibration as a voice therapy modality have been published, but many questions remain about the efficacy of this tool. The current project addresses these problems through a blinded and randomized controlled trial to investigate the efficacy of local translaryngeal vibration for MTD and the dose-response relationship of this modality when compared to treatment without vibration.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
a) diagnosis by an otolaryngologist of hyperfunctional dysphonia (MTD) without benign mid-membranous lesion (i.e., primary MTD or non-phonotraumatic hyperfunction) with and a recommendation for voice therapy, ((b) confirmation of dysphonia by a comprehensive voice evaluation conducted by a speech-language pathologist with experience in the evaluation and treatment of voice disordered populations, (c) to prevent floor effects of our primary outcome variable, participants will be required to exhibit a pre-treatment VHI score of >20, as this is the upper range for normal cutoff values in studies which have demonstrated high sensitivity and specificity for this tool (Behlau et al., 2016), (d) 18 years of age or older, (e) no history of local vibration therapy as part of a rehabilitation treatment program.
Disqualifiers
Unable to receive vibration to neck area
Trial design
Design model
Parallel
Treatments tested in this trial
Voice therapy with vibration
BehavioralVoice therapy with a novel vibration device will be delivered for five or eight weeks depending on group allocation. All participants will receive flow phonation voice therapy.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Five Week TherapyExperimental treatment 1 intervention
Group B: Eight Week TherapyActive comparator 1 intervention
Group C: Voice Therapy with PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Voice Handicap Index
The Voice Handicap Index (VHI) is a self-assessment tool used to evaluate how a voice disorder impacts a person's daily life, encompassing functional, physical, and emotional aspects. It helps quantify the perceived handicap caused by a voice problem, aiding in diagnosis, treatment planning, and assessing treatment effectiveness. The VHI consists of 30 questions, divided into three subscales, with scores ranging from 0 to 120, where higher scores indicate a greater perceived handicap
Time frame
From enrollment to the end of treatment at 5 or 8 weeks"Secondary outcomes
1
Consensus Auditory-Perceptual Evaluation of Voice
Perceptual Voice Quality measurement
Time frame
From enrollment to the end of treatment at 5 or 8 weeks"Sponsors and contacts
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Texas Christian University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov