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Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction

Primary Purpose

Voice Disorders, Vocal Fold Polyp, Vocal Nodules in Adults

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ambulatory Voice Monitoring with Biofeedback (AVM-B)
Conversation Training Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Voice Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Conversation Training Therapy with Ambulatory Voice Biofeedback

    Conversation Training Therapy alone

    Arm Description

    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.

    Conversation Training Therapy will be administered one time per week for 1 hour.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    Voice-Related Quality of Life (V-RQOL)
    The V-RQOL consists of 10 Likert-style questions ranging from 1-5 (1 = no problem at all; 2 = a small amount; 3 = a moderate problem; 4 = a lot; 5 = problem is as bas as it can be) that estimates how the subject's vocal function effects his/her daily life. This patient reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2023
    Last Updated
    July 31, 2023
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Boston Medical Center, Emory University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05970562
    Brief Title
    Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
    Official Title
    Preliminary Studies to Test the Effects of Ambulatory Biofeedback in Small Groups of Patients With Vocal Hyperfunction: Study 3
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2024 (Anticipated)
    Primary Completion Date
    September 1, 2028 (Anticipated)
    Study Completion Date
    April 1, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    Boston Medical Center, Emory University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Voice Disorders, Vocal Fold Polyp, Vocal Nodules in Adults, Muscle Tension Dysphonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conversation Training Therapy with Ambulatory Voice Biofeedback
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conversation Training Therapy alone
    Arm Type
    Active Comparator
    Arm Description
    Conversation Training Therapy will be administered one time per week for 1 hour.
    Intervention Type
    Device
    Intervention Name(s)
    Ambulatory Voice Monitoring with Biofeedback (AVM-B)
    Intervention Description
    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].
    Intervention Type
    Behavioral
    Intervention Name(s)
    Conversation Training Therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Generalization
    Description
    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 therapy
    Title
    Stimulability
    Description
    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.
    Title
    Rehabilitation Treatment Intensity Scale (RITS)
    Description
    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 therapy
    Title
    Consensus Auditory Perceptual Evaluation - Voice (CAPE-V)
    Description
    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 therapy
    Title
    Voice-Related Quality of Life (V-RQOL)
    Description
    The V-RQOL consists of 10 Likert-style questions ranging from 1-5 (1 = no problem at all; 2 = a small amount; 3 = a moderate problem; 4 = a lot; 5 = problem is as bas as it can be) that estimates how the subject's vocal function effects his/her daily life. This patient reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.
    Time Frame
    Before therapy, immediately after therapy, and 6 months after therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jarrad Van Stan, PhD, CCC-SLP
    Phone
    617-643-8410
    Email
    jvanstan@mgh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Hillman, PhD, CCC-SLP
    Phone
    617-643-2466
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jarrad Van Stan, PhD, CCC-SLP
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified data to be shared will include stimulability before therapy, average generalization each week of therapy, and patient-reported and clinician-rated outcomes before, after, and 6 months after voice therapy. These are the data that will be used in the analyses and the basis for manuscripts and results. Thus, they are the data necessary for the scientific community to replicate findings or integrate results into meta-analyses and data synthesis.
    IPD Sharing Time Frame
    Data will become available concurrent with publications where applicable and after the study finishes in 2029.
    IPD Sharing Access Criteria
    To maximize the appropriate sharing of scientific data and protect research participants' privacy and confidentiality, reuse of this dataset should use the following Data Use Limitations (DULs) under Controlled Access that is made available by a data repository only after approval of the request by the Harvard Dataverse independent review panel process; including Health/Medical/Biomedical controls and IRB Approval Required. To protect research participants' privacy and confidentiality, data submitted to the repository will not include personally identifiable information such as names, addresses, etc. Additional protections, such as the approach for managing Health Insurance Portability and Accountability Act identified, will be used for de-identification or to provide a limited data set to minimize the risk of participant reidentification.

    Learn more about this trial

    Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction

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