Translaryngeal Vibration for Hyperfunctional Voice Disorders

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 3
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. 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Texas
Texas Christian University
RECRUITING
Fort Worth
Contact Information
Primary
Christopher R Watts, Ph.D.
c.watts@tcu.edu
817-266-7891
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 30
Treatments
Experimental: Five Week Therapy
Participants receive five weeks of voice therapy with vibration
Active_comparator: Eight Week Therapy
Participants receive eight weeks of voice therapy with vibration
Placebo_comparator: Voice Therapy with Placebo
Participants receive eight weeks of voice therapy with vibration placebo
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Leads: Texas Christian University

This content was sourced from clinicaltrials.gov