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RECRUITING Early Phase 1 ClinicalTrials.gov

Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT05970562

Registry updated: 2026-09-08
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Description

Vocal hyperfunction (VH) is the most commonly treated class of voice disorders by speech-language pathologists and voice therapy is the primary curative treatment. Patients and clinicians report that generalizing improved voicing into daily life is the most significant barrier to successful therapy. We will test if extending biofeedback into the patient's daily life using ambulatory voice monitoring will significantly improve generalization during therapy and if individual patient factors, like how easily they can modify their voice and engagement during therapy, moderate the effects of the biofeedback.

Interventions

  • Ambulatory Voice Monitoring with Biofeedback (AVM-B) (Device)
    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 consists of cues every time the patient exceeds a subject-specific threshold, \[100% frequency AVM-B\] and/or summary statistics every 2 minutes of voicing \[Summary AVM-B\].
  • Conversation Training Therapy (Behavioral)
    CTT is a 4-week (1 45-minute session per week) evidence-based voice therapy for patients with VH, developed primarily to maximize the amount and speed of generalization outside the therapy session. It consists of 3 required targets: Decreased overall auditory-perceptual voice severity, improved discrimination between baseline and improved voicing, and adherence to CTT recommendations in daily life. The three optional targets are decreased overall auditory-perceptual severity across an increased pitch range, loudness range, and decreased rate of speech. All voice-related targets are modified through practicing voicing with increased forward resonance and mean airflow in spontaneous speech/conversation.

Eligibility criteria

Inclusion criteria for PVH: * Diagnosis of vocal fold nodules and polyps. * Secondary diagnosis of laryngopharyngeal reflux (LPR) or gastro-esophageal reflux disease (GERD) * Secondary diagnoses commonly associated with phonotrauma like erythema, edema, varies, ectasia, laryngitis, secondary/reactive muscle tension dysphonia (MTD), hemorrhage, etc. Exclusion criteria for PVH: * Any secondary diagnosis not directly related to phonotrauma, like cyst, sulk, cancer, bamboo nodule, known or suspected paralysis, etc. Inclusion criteria for NPVH: * Diagnosis of primary MTD. * Allowable secondary diagnoses are LPR and GERD. Exclusion criteria for NPVH: * Any secondary diagnosis related to pathological structure (e.g., nodules, polyps, edema, cancer), neurology (e.g., paralysis, Parkinson's Disease), or respiration (e.g., chronic cough, paradoxical vocal fold motion).

Conditions

Voice Disorders Vocal Fold Polyp Vocal Nodules in Adults Muscle Tension Dysphonia

Locations

  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • Boston Medical Center — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record