Biofeedback and voice therapy for vocal hyperfunction
Preliminary Studies to Test the Effects of Ambulatory Biofeedback in Small Groups of Patients With Vocal Hyperfunction: Study 3
This study is testing if adding biofeedback to regular voice therapy can help people with vocal hyperfunction improve their voice use in everyday life.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05970562 on ClinicalTrials.gov |
What this trial studies
This project aims to improve voice therapy outcomes for patients with vocal hyperfunction by integrating ambulatory voice monitoring with biofeedback into their daily lives. The study will randomize participants to receive either standard voice therapy or enhanced therapy that includes this biofeedback component. The goal is to assess whether this approach helps patients better generalize improved vocal behaviors outside of therapy sessions. The trial will also explore how individual patient factors influence the effectiveness of this intervention.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with vocal fold nodules, polyps, or muscle tension dysphonia.
Not a fit: Patients with secondary diagnoses unrelated to phonotrauma or those with structural vocal cord issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective voice therapy and improved quality of life for patients with vocal disorders.
How similar studies have performed: While voice therapy is a common treatment, the integration of ambulatory biofeedback is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jarrad Van Stan, PhD, CCC-SLP — Massachusetts General Hospital
- Study coordinator: Jarrad Van Stan, PhD, CCC-SLP
- Email: jvanstan@mgh.harvard.edu
- Phone: 617-643-8410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.