Project 4: Ambulatory Biofeedback and Voice Therapy for Patients with Vocal Hyperfunction
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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).
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Conversation Training Therapy with Ambulatory Voice Biofeedback |
Conversation Training Therapy will be administered one time per week for 1 hour. Ambulatory Voice Monitoring with Biofeedback will be administered during the second therapy session and for 5 days between the second and third therapy sessions. |
|
|
Active Comparator Conversation Training Therapy alone |
Conversation Training Therapy will be administered one time per week for 1 hour. |
|
Recruiting Locations
Boston, Massachusetts 02118
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
Vocal hyperfunction (VH) is ostensibly caused by and/or associated with pathological daily voice use and involves the most commonly treated voice disorders by speech-language pathologists, e.g., vocal fold nodules, muscle tension dysphonia. Voice therapy is the primary curative option for VH. For example, even when patients undergo laryngeal surgery to remove lesions, they are still thought to be at risk for recurrence unless they successfully complete post-surgical voice therapy. However, voice therapy suffers from high rates of patient dropout. Patients and clinicians report that generalizing desired vocal behaviors from the therapy session into daily life is one of the most significant barriers to successful voice therapy. Despite this critical barrier, voice therapy remains entirely dependent upon episodic delivery within an in-clinic or virtual session. Thus, this project will test if adding Ambulatory Voice Monitoring with Biofeedback (AVM-B) significantly addresses this generalization challenge, as it can directly extend therapeutic activities into the patient's daily life. A clinical trial will randomize patients with VH to receive an evidence-based therapy (Conversation Training Therapy; CTT) or CTT with AVM-B added. In Aim 1, it is hypothesized that, compared to patients who only received CTT, patients who receive CTT and AVM-B will demonstrate significantly better generalization during therapy which will be retained immediately after therapy and six months later. In Aim 2, we will explore patient factors that mediate the relationship between therapy and generalization, hypothesizing that stimulabilty-how easily a patient can modify their voice-and engagement-the patient's level of effort during therapy-will be positively correlated to the amount of generalization in daily life. If successful, this work would result in multiple paradigm-shifting impacts with potential to improve the efficiency of clinical practice. AVM-B would become one of the first evidence-based voice treatment activities taking place primarily outside the therapy session. Future work could investigate how AVM-B could transition voice therapy from once-a-week sessions into a continuous process integrated into the patient's daily life. Further inquiry could improve generalization by identifying evidence-based methods to tailor therapy based on individual patient factors such as stimulability and engagement. After discharge, AVM-B could provide a means for patients to "recalibrate" themselves and prevent relapse without having to see a clinician. Finally, implementation work could help clinicians adopt/adapt AVM-B and evaluate its effects on dropouts.