Translaryngeal Vibration for Hyperfunctional Voice Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

NCT02718963

Deglutition Disorders

COMPLETED NA

Establish Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment

NCT02243722

Unilateral Vocal Cord Paralysis

UNKNOWN

Laryngeal Cryotherapy for Refractory Neurogenic Cough

NCT05665244

Upper-Airway Cough Syndrome

RECRUITING

The Efficacy of Vocal Function Exercises for Laryngeal Cancers

NCT02156518

Vocal Folds

COMPLETED NA

Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

NCT04764604

Muscle Tension Dysphonia Vocal Fold Palsy Vocal Cord Paralysis +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 behavioral voice therapy for MTD, one of the most effective evidence-based approaches is flow phonation (a.k.a., stretch-and-flow voice therapy). However, the phenomenon of post-treatment outcome measures remaining substantially outside the range of normal is a ubiquitous finding in studies investigating this and other voice therapy approaches. From both a cost burden and quality of life perspective, this phenomenon supports a need to develop and refine voice therapy treatment approaches to promote better outcomes. Vibration is a physical modality that has a historical use in the rehabilitation professions, but only recently has it been scientifically studied as a modality for voice therapy when used by speech-language pathologists. When applied locally on the perilaryngeal surface as a local translaryngeal vibration therapy (LTLV), early research has demonstrated beneficial effects on voice physiology and clinical outcomes. Further high-quality clinical research studies are needed to evaluate the efficacy of LTLV as a modality for voice disorders and to better understand the effects of vibration and effective vibration dose on voice rehabilitation outcomes. The research proposed in this R15 has the potential to transform clinical practice of treatment for MTD, the most common voice disorder among treatment-seeking populations. That potential is vested in the pursuit of three specific aims: (1) determine the clinical efficacy of LTLV as a concurrent treatment using flow phonation voice therapy in patients with MTD, and (2) determine the effect of treatment dose on clinical response associated with treatment outcomes. In addition to the potential impact of this R15, the innovative of approach of using LTLV as a concurrent modality with flow phonation combined with investigation of the most effective frequency parameter for clinical application represents a pioneering approach to advance the field of clinical voice practice in speech-language pathology.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysphonia Muscle Tension Dysphonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Five Week Therapy

Participants receive five weeks of voice therapy with vibration

Group Type EXPERIMENTAL

Voice therapy with vibration

Intervention Type 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.

Eight Week Therapy

Participants receive eight weeks of voice therapy with vibration

Group Type ACTIVE_COMPARATOR

Voice therapy with vibration

Intervention Type 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.

Voice Therapy with Placebo

Participants receive eight weeks of voice therapy with vibration placebo

Group Type PLACEBO_COMPARATOR

Voice therapy with vibration

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Voice therapy with vibration

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.