Status:
RECRUITING
Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Boston Medical Center
Emory University
Conditions:
Voice Disorders
Vocal Fold Polyp
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
Vocal hyperfunction (VH) is ostensibly caused by and/or associated with pathological daily voice use and involves the most commonly treated voice disorders by speech-language pathologists, e.g., vocal...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05970562
Start Date
March 1 2024
End Date
April 1 2029
Last Update
May 11 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Boston Medical Center
Boston, Massachusetts, United States, 02118