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Search / Trial NCT05970562

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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 31, 2023

Trial Information

Current as of July 09, 2025

Recruiting

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).

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Jarrad Van Stan, PhD, CCC-SLP

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported