Translaryngeal Vibration for Hyperfunctional Voice Disorders

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Texas Christian University
Study ID
NCT07145086
Phase
PHASE3
Status
Recruiting
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Conditions

  • Dysphonia
  • Muscle Tension Dysphonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Voice therapy with vibration — BEHAVIORAL
    Voice 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.

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Voice Handicap Index [ Time Frame: From enrollment to the end of treatment at 5 or 8 weeks" ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Christian UniversityFort WorthTexas76109
Christopher R Watts, Ph.D.
[email protected]
817-257-6878
Christopher R Watts, Ph.D. (PRINCIPAL_INVESTIGATOR)

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Texas Christian University· Fort Worth, TX

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