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

Preliminary Studies to Test the Effects of Ambulatory Biofeedback in Small Groups of Patients With Vocal Hyperfunction: Study 3

Who can join

Ages 18 to 65 · All sexes

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).

About the study

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.

What is being tested

• Ambulatory Voice Monitoring with Biofeedback (AVM-B) (device)
• Conversation Training Therapy (behavioral)

Sponsor: Massachusetts General Hospital · Participants: 100 · Started: Mar 1, 2024

Contact the study team

• Jarrad Van Stan, PhD, CCC-SLP · Phone: 216-687-3883
• Robert Hillman, PhD, CCC-SLP · Phone: 617-643-2466

Official record on ClinicalTrials.gov — NCT05970562

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.