Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
ID05970562

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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