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Recruiting
NCT05970562
Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
Conditions: Voice Disorders, Vocal Fold Polyp, Vocal Nodules in Adults, Muscle Tension Dysphonia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 100
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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.
Eligibility Criteria
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).
Source: ClinicalTrials.gov (NCT05970562). StuddyBuddy aggregates publicly available trial information.