Status:
RECRUITING
Translaryngeal Vibration for Hyperfunctional Voice Disorders
Lead Sponsor:
Texas Christian University
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Dysphonia
Muscle Tension Dysphonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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. Rec...
Detailed Description
High-quality research designs have demonstrated that voice therapy has a positive impact on hyperfunctional voice disorders associated with muscle tension dysphonia (MTD). Among the options of behavio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Unable to receive vibration to neck area
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07145086
Start Date
September 1 2024
End Date
August 31 2027
Last Update
August 28 2025
Active Locations (1)
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1
Texas Christian University
Fort Worth, Texas, United States, 76109