Biofeedback and voice therapy for vocal hyperfunction
Official title: Preliminary Studies to Test the Effects of Ambulatory Biofeedback in Small Groups of Patients With Vocal Hyperfunction: Study 3
Run by Massachusetts General Hospital · NCT05970562 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | September 1, 2028 |
| Study ends | April 1, 2029 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT05970562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with vocal fold nodules, polyps, or muscle tension dysphonia.
✕Probably not a fit
Patients with secondary diagnoses unrelated to phonotrauma or those with structural vocal cord issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Boston Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Robert Hillman, PhD, CCC-SLP — Massachusetts General Hospital
- Study coordinator: Jarrad Van Stan, PhD, CCC-SLP
- Email: j.vanstan82@csuohio.edu
- Phone: 216-687-3883
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.