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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ambulatory Voice Monitoring with Biofeedback (AVM-B)
DeviceAVM-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
BehavioralCTT 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Conversation Training Therapy with Ambulatory Voice BiofeedbackExperimental treatment 2 interventions
Group B: Conversation Training Therapy aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Generalization
Generalization will be represented as a "percent accuracy" where voiced frames of a feature that are above or below a percentile threshold (based on baseline/pre-therapy monitoring data) are divided by the total number of voiced frames.
Time frame
Before therapy, immediately after therapy, and 6 months after therapy2
Stimulability
Stimulability will be represented as a "percent accuracy" where voiced frames of a feature that are above or below a percentile threshold (based on baseline/pre-therapy monitoring data) are divided by the total number of voiced frames.
Time frame
This will be calculated before therapy begins.3
Rehabilitation Treatment Intensity Scale (RITS)
The RITS scale is one scale with 7 levels where the 1 represents the "absence of effort" and 7 represents "superior effort." The patient's treating clinician will judge his/her engagement during therapy after each session. These judgements will provide valid and reliable estimates of patient engagement.
Time frame
Before therapy, immediately after therapy, and 6 months after therapy4
Consensus Auditory Perceptual Evaluation - Voice (CAPE-V)
The CAPE-V consists of 4 perceptually judged 100-mm visual analog scales (Overall auditory perceptual severity, Breathiness, Strain, Roughness). The patient's treating clinician will judge standard audio samples. These judgements provide gold-standard perceptual ratings of voice quality to evaluate if therapy and AVM-B are associated with improved voice quality.
Time frame
Before therapy, immediately after therapy, and 6 months after therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Boston Medical Center
Collaborator
Emory University
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Cleveland State University
Collaborator
Source ClinicalTrials.gov