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

NCT05970562 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-11

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Ambulatory Voice Monitoring with Biofeedback (AVM-B)

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 \[Summary AVM-B\].

BEHAVIORAL

Conversation Training Therapy

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.

Sponsors & Collaborators

  • Boston Medical Center

    collaborator OTHER
  • Emory University

    collaborator OTHER
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jarrad Van Stan, PhD, CCC-SLP · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2028-09-01
Completion
2029-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05970562 on ClinicalTrials.gov