Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
Any secondary diagnosis not directly related to phonotrauma, like cyst, sulk, cancer, bamboo nodule, known or suspected paralysis, etc.
Diagnosis of primary MTD.
Allowable secondary diagnoses are LPR and GERD.
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).
Trial design
Treatments tested in this trial
- Ambulatory Voice Monitoring with Biofeedback (AVM-B)
- Conversation Training Therapy
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Boston Medical Center
Collaborator
Emory University
Collaborator
Source ClinicalTrials.gov