Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
NCT05970562 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-05-11
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.
Conditions
- Voice Disorders
- Vocal Fold Polyp
- Vocal Nodules in Adults
- Muscle Tension Dysphonia
Interventions
- DEVICE
-
Ambulatory Voice Monitoring with Biofeedback (AVM-B)
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 \[Summary AVM-B\].
- BEHAVIORAL
-
Conversation Training Therapy
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.
Sponsors & Collaborators
-
Boston Medical Center
collaborator OTHER -
Emory University
collaborator OTHER -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Jarrad Van Stan, PhD, CCC-SLP · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2028-09-01
- Completion
- 2029-04-01
Countries
- United States
Study Locations
More Related Trials
-
Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy
NCT02518425 ·Status: COMPLETED
-
Testing a Smart Phone App to Enhance Voice Therapy Adherence
NCT04002336 ·Status: COMPLETED ·Phase: NA
-
Intensive Versus Traditional Voice Therapy
NCT03129880 ·Status: COMPLETED ·Phase: NA
-
PhoRTE® Therapy Efficacy: In-Person Versus Telehealth
NCT06934265 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Prevention and Treatment of Voice Problems in Teachers
NCT01199172 ·Status: COMPLETED ·Phase: NA
-
Hybrid Model of Vocal Inflammation and Tissue Mobilization
NCT01197339 ·Status: COMPLETED ·Phase: PHASE1
-
The Effects of Voice Therapy Based on the Estill Voice Model: a Feasibility Study
NCT02647840 ·Status: COMPLETED ·Phase: NA
-
Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia
NCT05158179 ·Status: COMPLETED ·Phase: NA
-
Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults
NCT03762993 ·Status: COMPLETED ·Phase: NA
-
Visual Acoustic Biofeedback for RSE Via Telepractice
NCT04858022 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment for Teachers With Vocal Fatigue
NCT04486989 ·Status: COMPLETED ·Phase: NA
-
Neurogenic Dysphonia/Dysphagia Registry
NCT02493491 ·Status: TERMINATED
-
Singing-voice Disorders and Aerodynamic Profiles in Dysodic Singers
NCT04036864 ·Status: UNKNOWN
-
Tracking Biomarkers of Speech Intelligibility
NCT05145946 ·Status: WITHDRAWN ·Phase: NA
-
Artificial Intelligence and Benign Lesions of Vocal Folds Recognition
NCT05754606 ·Status: RECRUITING
-
Effectiveness of Acupuncture for Phonotraumatic Injuries
NCT00803582 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy of Flow Ball Phonation in Professional Voice Users
NCT06960772 ·Status: RECRUITING ·Phase: NA
-
Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change
NCT02061943 ·Status: WITHDRAWN
-
Here, My Voice 2 Voice Lessons Pilot
NCT05336747 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Auditory Mirror-therapy for Tinnitus
NCT05710172 ·Status: COMPLETED ·Phase: NA
-
Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment
NCT03083106 ·Status: COMPLETED ·Phase: NA
-
Characterizing the Impact of Presbyphonia on Social Interaction
NCT06441136 ·Status: RECRUITING ·Phase: NA
-
Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction
NCT02114762 ·Status: COMPLETED ·Phase: NA
-
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.
NCT04357704 ·Status: WITHDRAWN ·Phase: NA
-
Improving Speech in Noise Using Noninvasive Stimulation
NCT07176936 ·Status: RECRUITING ·Phase: NA