Actively Recruiting
Effects of Ambulatory Biofeedback Added to Conversation Training Therapy for Vocal Hyperfunction
Led by Massachusetts General Hospital · Updated on 2025-05-11
100
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
Boston Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying vocal hyperfunction (VH), a common voice disorder treated by speech-language pathologists, to improve how patients generalize better voice use from therapy sessions into everyday life. The study evaluates if adding Ambulatory Voice Monitoring with Biofeedback (AVM-B) to standard voice therapy helps patients apply improved vocal behaviors outside therapy. This early-phase clinical trial also explores how patient factors like voice change ability and therapy engagement influence treatment effects. Participants will be randomly assigned to two groups: one receiving Conversation Training Therapy (CTT) alone, and the other receiving CTT combined with AVM-B. CTT involves weekly 45-minute voice therapy sessions over four weeks aimed at improving vocal function. The AVM-B device uses a neck sensor to monitor voice use in daily life and provides biofeedback cues and summaries to encourage better vocal habits. AVM-B is used starting in the second therapy session and continues for five days between the second and third sessions. During the trial, participants will be assessed before therapy, immediately after, and six months later using voice-related measures including generalization of improved voicing, stimulability, treatment intensity, auditory perceptual evaluation, and voice-related quality of life. Researchers will monitor how voice therapy combined with AVM-B affects daily voice use and quality of life over time. The study aims to last several months with follow-up to evaluate sustained benefits and individual differences in therapy response.
CONDITIONS
Brief Title
Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 such as erythema, edema, varices, ectasia, laryngitis, secondary/reactive muscle tension dysphonia (MTD), hemorrhage
- Diagnosis of primary muscle tension dysphonia (MTD)
- Allowable secondary diagnoses are LPR and GERD
You will not qualify if you...
- Any secondary diagnosis not directly related to phonotrauma, such as cyst, sulcus, cancer, bamboo nodule, known or suspected paralysis
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive Conversation Training Therapy once a week for 4 weeks. Participants in the experimental group also receive Ambulatory Voice Monitoring with Biofeedback during the second therapy session and for 5 days between the second and third therapy sessions to help generalize voice therapy into daily life.
4 weekly visits (in-person or virtual)
Duration - 6 months
Participants are assessed immediately after therapy and again 6 months later to evaluate retention of therapy effects and voice quality.
2 visits (in-person or virtual)
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
Research Team
J
Jarrad Van Stan, PhD, CCC-SLP
R
Robert Hillman, PhD, CCC-SLP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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