Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
NCT05970562

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

Led by Massachusetts General Hospital · Updated on 2025-05-11

100

Participants Needed

2

Research Sites

265 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

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

Official 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 related to 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 include LPR and GERD
Not Eligible

You will not qualify if you...

  • Any secondary diagnosis not related to phonotrauma, such as cyst, sulcus, cancer, bamboo nodule, known or suspected paralysis
  • Secondary diagnoses related to pathological structures like nodules, polyps, edema, cancer
  • Neurological conditions such as paralysis or Parkinson's Disease
  • Respiratory conditions like chronic cough or paradoxical vocal fold motion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

R

Robert Hillman, PhD, CCC-SLP

CONTACT

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