xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05970562</url>
    </required_header>
    <id_info>
      <org_study_id>2016P002849C</org_study_id>
      <nct_id>NCT05970562</nct_id>
    </id_info>
    <brief_title>Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction</brief_title>
    <official_title>Preliminary Studies to Test the Effects of Ambulatory Biofeedback in Small Groups of Patients With Vocal Hyperfunction: Study 3</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Boston Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Vocal hyperfunction (VH) is the most commonly treated class of voice disorders by&#xD;
        speech-language pathologists and voice therapy is the primary curative treatment. Patients&#xD;
        and clinicians report that generalizing improved voicing into daily life is the most&#xD;
        significant barrier to successful therapy. We will test if extending biofeedback into the&#xD;
        patient's daily life using ambulatory voice monitoring will significantly improve&#xD;
        generalization during therapy and if individual patient factors, like how easily they can&#xD;
        modify their voice and engagement during therapy, moderate the effects of the biofeedback.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Vocal hyperfunction (VH) is ostensibly caused by and/or associated with pathological daily&#xD;
        voice use and involves the most commonly treated voice disorders by speech-language&#xD;
        pathologists, e.g., vocal fold nodules, muscle tension dysphonia. Voice therapy is the&#xD;
        primary curative option for VH. For example, even when patients undergo laryngeal surgery to&#xD;
        remove lesions, they are still thought to be at risk for recurrence unless they successfully&#xD;
        complete post-surgical voice therapy. However, voice therapy suffers from high rates of&#xD;
        patient dropout. Patients and clinicians report that generalizing desired vocal behaviors&#xD;
        from the therapy session into daily life is one of the most significant barriers to&#xD;
        successful voice therapy. Despite this critical barrier, voice therapy remains entirely&#xD;
        dependent upon episodic delivery within an in-clinic or virtual session. Thus, this project&#xD;
        will test if adding Ambulatory Voice Monitoring with Biofeedback (AVM-B) significantly&#xD;
        addresses this generalization challenge, as it can directly extend therapeutic activities&#xD;
        into the patient's daily life. A clinical trial will randomize patients with VH to receive an&#xD;
        evidence-based therapy (Conversation Training Therapy; CTT) or CTT with AVM-B added. In Aim&#xD;
        1, it is hypothesized that, compared to patients who only received CTT, patients who receive&#xD;
        CTT and AVM-B will demonstrate significantly better generalization during therapy which will&#xD;
        be retained immediately after therapy and six months later. In Aim 2, we will explore patient&#xD;
        factors that mediate the relationship between therapy and generalization, hypothesizing that&#xD;
        stimulabilty-how easily a patient can modify their voice-and engagement-the patient's level&#xD;
        of effort during therapy-will be positively correlated to the amount of generalization in&#xD;
        daily life. If successful, this work would result in multiple paradigm-shifting impacts with&#xD;
        potential to improve the efficiency of clinical practice. AVM-B would become one of the first&#xD;
        evidence-based voice treatment activities taking place primarily outside the therapy session.&#xD;
        Future work could investigate how AVM-B could transition voice therapy from once-a-week&#xD;
        sessions into a continuous process integrated into the patient's daily life. Further inquiry&#xD;
        could improve generalization by identifying evidence-based methods to tailor therapy based on&#xD;
        individual patient factors such as stimulability and engagement. After discharge, AVM-B could&#xD;
        provide a means for patients to &quot;recalibrate&quot; themselves and prevent relapse without having&#xD;
        to see a clinician. Finally, implementation work could help clinicians adopt/adapt AVM-B and&#xD;
        evaluate its effects on dropouts.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2024</start_date>
    <completion_date type="Anticipated">April 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2028</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Generalization</measure>
      <time_frame>Before therapy, immediately after therapy, and 6 months after therapy</time_frame>
      <description>Generalization will be represented as a &quot;percent accuracy&quot; 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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stimulability</measure>
      <time_frame>This will be calculated before therapy begins.</time_frame>
      <description>Stimulability will be represented as a &quot;percent accuracy&quot; 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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rehabilitation Treatment Intensity Scale (RITS)</measure>
      <time_frame>Before therapy, immediately after therapy, and 6 months after therapy</time_frame>
      <description>The RITS scale is one scale with 7 levels where the 1 represents the &quot;absence of effort&quot; and 7 represents &quot;superior effort.&quot; 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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Consensus Auditory Perceptual Evaluation - Voice (CAPE-V)</measure>
      <time_frame>Before therapy, immediately after therapy, and 6 months after therapy</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voice-Related Quality of Life (V-RQOL)</measure>
      <time_frame>Before therapy, immediately after therapy, and 6 months after therapy</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Voice Disorders</condition>
    <condition>Vocal Fold Polyp</condition>
    <condition>Vocal Nodules in Adults</condition>
    <condition>Muscle Tension Dysphonia</condition>
    <arm_group>
      <arm_group_label>Conversation Training Therapy with Ambulatory Voice Biofeedback</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conversation Training Therapy alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conversation Training Therapy will be administered one time per week for 1 hour.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ambulatory Voice Monitoring with Biofeedback (AVM-B)</intervention_name>
      <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].</description>
      <arm_group_label>Conversation Training Therapy with Ambulatory Voice Biofeedback</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Conversation Training Therapy</intervention_name>
      <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.</description>
      <arm_group_label>Conversation Training Therapy alone</arm_group_label>
      <arm_group_label>Conversation Training Therapy with Ambulatory Voice Biofeedback</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria for PVH:&#xD;
  &#xD;
            -  Diagnosis of vocal fold nodules and polyps.&#xD;
  &#xD;
            -  Secondary diagnosis of laryngopharyngeal reflux (LPR) or gastro-esophageal reflux&#xD;
               disease (GERD)&#xD;
  &#xD;
            -  Secondary diagnoses commonly associated with phonotrauma like erythema, edema, varies,&#xD;
               ectasia, laryngitis, secondary/reactive muscle tension dysphonia (MTD), hemorrhage,&#xD;
               etc.&#xD;
  &#xD;
          Exclusion criteria for PVH:&#xD;
  &#xD;
            -  Any secondary diagnosis not directly related to phonotrauma, like cyst, sulk, cancer,&#xD;
               bamboo nodule, known or suspected paralysis, etc.&#xD;
  &#xD;
          Inclusion criteria for NPVH:&#xD;
  &#xD;
            -  Diagnosis of primary MTD.&#xD;
  &#xD;
            -  Allowable secondary diagnoses are LPR and GERD.&#xD;
  &#xD;
          Exclusion criteria for NPVH:&#xD;
  &#xD;
            -  Any secondary diagnosis related to pathological structure (e.g., nodules, polyps,&#xD;
               edema, cancer), neurology (e.g., paralysis, Parkinson's Disease), or respiration&#xD;
               (e.g., chronic cough, paradoxical vocal fold motion).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jarrad Van Stan, PhD, CCC-SLP</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jarrad Van Stan, PhD, CCC-SLP</last_name>
      <phone>617-643-8410</phone>
      <email>jvanstan@mgh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Robert Hillman, PhD, CCC-SLP</last_name>
      <phone>617-643-2466</phone>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Jarrad Van Stan</investigator_full_name>
      <investigator_title>Associate Professor, Research Speech Language Pathologist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dysphonia</mesh_term>
      <mesh_term>Voice Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will become available concurrent with publications where applicable and after the study finishes in 2029.</ipd_time_frame>
      <ipd_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.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05970562
  org study id: 2016P002849C
  nct id: NCT05970562
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Generalization
  time frame: Before therapy, immediately after therapy, and 6 months after therapy
  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.
  measure: Stimulability
  time frame: This will be calculated before therapy begins.
  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.
  measure: Rehabilitation Treatment Intensity Scale (RITS)
  time frame: Before therapy, immediately after therapy, and 6 months after therapy
  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.
  measure: Consensus Auditory Perceptual Evaluation - Voice (CAPE-V)
  time frame: Before therapy, immediately after therapy, and 6 months after therapy
  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.
  measure: Voice-Related Quality of Life (V-RQOL)
  time frame: Before therapy, immediately after therapy, and 6 months after therapy
  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.
  arm group label: Conversation Training Therapy with Ambulatory Voice Biofeedback
  arm group type: Experimental
  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 group label: Conversation Training Therapy alone
  arm group type: Active Comparator
  description: Conversation Training Therapy will be administered one time per week for 1 hour.
  intervention type: Device
  intervention name: Ambulatory Voice Monitoring with Biofeedback (AVM-B)
  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].
  arm group label: Conversation Training Therapy with Ambulatory Voice Biofeedback
  intervention type: Behavioral
  intervention name: Conversation Training Therapy
  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.
  arm group label: Conversation Training Therapy alone
  arm group label: Conversation Training Therapy with Ambulatory Voice Biofeedback
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Jarrad Van Stan, PhD, CCC-SLP
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Jarrad Van Stan, PhD, CCC-SLP
  phone: 617-643-8410
  email: jvanstan@mgh.harvard.edu
  last name: Robert Hillman, PhD, CCC-SLP
  phone: 617-643-2466
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Jarrad Van Stan
  investigator title: Associate Professor, Research Speech Language Pathologist
  mesh term: Dysphonia
  mesh term: Voice Disorders
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data will become available concurrent with publications where applicable and after the study finishes in 2029.
  ipd 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.