30 Participants Needed

Translaryngeal Vibration for Hoarseness

CR
Overseen ByChristopher R Watts, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Texas Christian University
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating muscle tension dysphonia (MTD), a voice disorder that causes a hoarse or strained voice. The study examines whether throat vibrations can improve the voice more effectively than regular therapy without vibrations. Participants will receive either five or eight weeks of voice therapy with vibration or eight weeks of therapy with a placebo vibration. Individuals diagnosed with MTD by a doctor who have not previously tried vibration therapy may be suitable for this trial. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking therapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that voice therapy using vibration is generally easy for people to handle. In one study, participants experienced significant improvements in their voice without any serious side effects. Another study found that this therapy can improve voice quality and reduce strain. Since this treatment is in the final stages of testing, earlier tests likely did not find major safety concerns. Overall, the evidence indicates that vibration-based voice therapy is a safe option for people with voice disorders.12345

Why do researchers think this study treatment might be promising for hoarseness?

Researchers are excited about the translaryngeal vibration technique for hoarseness because it introduces a unique approach by using vibration during voice therapy. Unlike standard treatments such as vocal rest, medications, or traditional voice therapy, this method potentially enhances vocal recovery by directly stimulating the vocal cords. The trial examines two durations of therapy—five weeks and eight weeks—alongside a placebo group, which could help determine the optimal treatment length. This innovative use of vibration aims to improve vocal function more effectively and possibly more quickly than existing options.

What evidence suggests that translaryngeal vibration is effective for muscle tension dysphonia?

Research has shown that vibration therapy might be a promising way to treat voice problems like muscle tension dysphonia (MTD). In one study, up to 57% of participants noticed significant improvement in voice quality after using vibration therapy on their voice box. Other studies have found that this therapy also improved how people felt about their voice and reduced the impact of voice problems on their lives. This trial will compare different durations of voice therapy with vibration, including five-week and eight-week therapies, as well as a placebo version. Overall, early results are encouraging and suggest that vibration therapy could effectively treat hoarseness and other voice issues.16789

Are You a Good Fit for This Trial?

This trial is for individuals with voice disorders like dysphonia or hoarseness, specifically those experiencing muscle tension in their vocal cords. Participants should be diagnosed with a hyperfunctional voice disorder and have not found relief from standard treatments.

Inclusion Criteria

Participants must exhibit a pre-treatment VHI score of >20 to prevent floor effects of the primary outcome variable
I am 18 years old or older.
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
See 2 more

Exclusion Criteria

I cannot have treatments that involve vibrations on my neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive voice therapy with translaryngeal vibration or placebo for 5 or 8 weeks

5-8 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Voice therapy with vibration
Trial Overview The study tests the effectiveness of using translaryngeal vibration during voice therapy to treat muscle tension dysphonia (MTD). It's a controlled trial where some participants will receive the vibration treatment while others won't, to compare outcomes.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Five Week TherapyExperimental Treatment1 Intervention
Group II: Eight Week TherapyActive Control1 Intervention
Group III: Voice Therapy with PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Christian University

Lead Sponsor

Trials
31
Recruited
4,400+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30025623/
Treatment Effectiveness of Novafon Local Vibration Voice ...The objective of this study was to explore the effectiveness of the five-week Novafon local vibration voice therapy (NLVVT) program with and without Novafon ...
Treatment Effectiveness of Novafon Local Vibration Voice ...The results of the present study showed that the NLVVT program might be an effective voice treatment for subjects with dysphonia.
Laryngeal Vibration as a Treatment for the Voice Disorder ...The main findings were that up to 57% of participants showed a meaningful improvement in an objective voice measure (Cepstral Peak Power) or a reduction in ...
Assessing the Effectiveness of Voice Therapy Techniques in ...The physiologic voice therapy group showed significant improvements in VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice ...
Treatment Effectiveness of Novafon Local Vibration ...The objective of this study was to explore the effectiveness of the five-week Novafon local vibration voice therapy (NLVVT) program with and ...
Feasibility and Acceptability of Complete Vocal Technique ...The primary outcome measure was the Voice Handicap Index (VHI), a validated self-reported measure that quantifies the psychosocial consequences ...
Examining Therapy Duration in Adults With Voice DisordersThis study examined the number of voice therapy sessions and the number of weeks in treatment to achieve desired voice outcomes in adults with voice disorders.
Translaryngeal Vibration for HoarsenessThis Phase 3 medical study run by Texas Christian University is evaluating whether Voice therapy with vibration will have tolerable side effects & efficacy ...
Project 4: Ambulatory Biofeedback and Voice Therapy for ...AVM-B is software on the Voice Health Monitor that uses a neck-placed accelerometer to sense neck skin vibrations during voicing in daily life. The AVM-B ...
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