What this study is
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.
What's being tested
- Ambulatory Voice Monitoring with Biofeedback (AVM-B)
Intervention · DEVICE
AVM-B is software on the Voice Health Monitor that uses a neck-placed accelerometer to sense neck skin vibrations during voicing in daily life. The AVM-B consists of cues every time the patient exceeds a subject-specific threshold, [100% frequency AVM-B] and/or summary statistics every 2 minutes of voicing [Summary AVM-B].
- Conversation Training Therapy
Intervention · BEHAVIORAL
CTT is a 4-week (1 45-minute session per week) evidence-based voice therapy for patients with VH, developed primarily to maximize the amount and speed of generalization outside the therapy session. It consists of 3 required targets: Decreased overall auditory-perceptual voice severity, improved discrimination between baseline and improved voicing, and adherence to CTT recommendations in daily life. The three optional targets are decreased overall auditory-perceptual severity across an increased pitch range, loudness range, and decreased rate of speech. All voice-related targets are modified through practicing voicing with increased forward resonance and mean airflow in spontaneous speech/conversation.
Study details
- Official title
- Preliminary Studies to Test the Effects of Ambulatory Biofeedback in Small Groups of Patients With Vocal Hyperfunction: Study 3
- Sponsor
- Massachusetts General Hospital
- Conditions
- Voice Disorders · Vocal Fold Polyp · Vocal Nodules in Adults · Muscle Tension Dysphonia
- Enrolling
- 100 people
- Starts
- 2024-03-01
- Est. completion
- 2029-04-01
- Design
- Single-blind, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedPVH
You may qualify if
- 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.
You can't join if
- Any secondary diagnosis not directly related to phonotrauma, like cyst, sulk, cancer, bamboo nodule, known or suspected paralysis, etc.
NPVH
You may qualify if
- Diagnosis of primary MTD.
- Allowable secondary diagnoses are LPR and GERD.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Robert Hillman, PhD, CCC-SLP · Contact617-643-2466HILLMAN.ROBERT@MGH.HARVARD.EDU
RecruitingBoston Medical Center
Boston, Massachusetts, United States
- Lauren Tracy, MD · Contact617-638-8124Lauren.Tracy@bmc.org
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2016P002849C
Principal investigator
Robert Hillman, PhD, CCC-SLP
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.