NCT05970562 Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
| NCT ID | NCT05970562 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Voice Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-03-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 generalizing improved voicing into daily life is the most significant barrier to successful therapy. We will test if extending biofeedback into the patient's daily life using ambulatory voice monitoring will significantly improve generalization during therapy and if individual patient factors, like how easily they can modify their voice and engagement during therapy, moderate the effects of the biofeedback.
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).
Contact & Investigator
Robert Hillman, PhD, CCC-SLP
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05970562 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Voice Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05970562 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05970562 currently recruiting?
Yes, NCT05970562 is actively recruiting participants. Contact the research team at j.vanstan82@csuohio.edu for enrollment information.
Where is the NCT05970562 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT05970562 clinical trial?
NCT05970562 is sponsored by Massachusetts General Hospital. The principal investigator is Robert Hillman, PhD, CCC-SLP at Massachusetts General Hospital. The trial plans to enroll 100 participants.