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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial, called Project 4, is studying a new approach to help people with voice disorders, specifically those who struggle with vocal hyperfunction, which means they have difficulty using their voice properly. The trial will explore whether using special devices to monitor voice use in everyday situations can improve the effectiveness of voice therapy. Many patients find it hard to apply what they learn in therapy to their daily lives, so this study aims to see if real-time feedback can help bridge that gap and make therapy more successful.

To participate in this trial, individuals need to be between the ages of 18 and 75 and have specific voice issues, such as vocal fold nodules or polyps, or muscle tension dysphonia (MTD). Participants will receive voice therapy and use biofeedback tools to track their voice use outside of therapy sessions. The study is currently recruiting, and it aims to understand how individual factors, like a person's ability to adjust their voice and their involvement in therapy, might influence the outcomes. This trial could offer a promising new way to help people improve their voice health and communication skills.

Gender

ALL

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).