[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513829":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":71,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":26,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Conversation Training Therapy with Ambulatory Voice Biofeedback","EXPERIMENTAL","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.",[13,14],"Device: Ambulatory Voice Monitoring with Biofeedback (AVM-B)","Behavioral: Conversation Training Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Conversation Training Therapy alone","ACTIVE_COMPARATOR","Conversation Training Therapy will be administered one time per week for 1 hour.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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\u002For summary statistics every 2 minutes of voicing \\[Summary AVM-B\\].",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"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\u002Fconversation.",[16,9],[33],{"name":34,"affiliation":5,"role":35},"Jarrad Van Stan, PhD, CCC-SLP","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","617-643-8410","jvanstan@mgh.harvard.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":26},"Robert Hillman, PhD, CCC-SLP","617-643-2466",[45,60],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-71.05977,42.35843,{"lat":56,"lon":55},[59],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},{"facility":61,"status":46,"city":47,"state":48,"zip":62,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Boston Medical Center","02118",{"type":53,"coordinates":64},[55,56],{"lat":56,"lon":55},[67],{"name":68,"role":38,"phone":69,"phoneExt":26,"email":70},"Lauren Tracy, MD","617-638-8124","Lauren.Tracy@bmc.org",{"type":35,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jarrad Van Stan","Associate Professor, Research Speech Language Pathologist",[75,76],{"name":61,"class":6},{"name":77,"class":6},"Emory University","100513829","early-phase-1-project-4-ambulatory-biofeedback-and-voice-therapy-for-patients-with-vocal-hyperfunction-100513829",false,"NCT05970562","Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction","Preliminary Studies to Test the Effects of Ambulatory Biofeedback in Small Groups of Patients With Vocal Hyperfunction: Study 3","Inclusion criteria for PVH:\n\n* Diagnosis of vocal fold nodules and polyps.\n* Secondary diagnosis of laryngopharyngeal reflux (LPR) or gastro-esophageal reflux disease (GERD)\n* Secondary diagnoses commonly associated with phonotrauma like erythema, edema, varies, ectasia, laryngitis, secondary\u002Freactive muscle tension dysphonia (MTD), hemorrhage, etc.\n\nExclusion criteria for PVH:\n\n* Any secondary diagnosis not directly related to phonotrauma, like cyst, sulk, cancer, bamboo nodule, known or suspected paralysis, etc.\n\nInclusion criteria for NPVH:\n\n* Diagnosis of primary MTD.\n* Allowable secondary diagnoses are LPR and GERD.\n\nExclusion criteria for NPVH:\n\n* 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).","ALL","18 Years","65 Years",{"count":89,"type":90},100,"ESTIMATED","INTERVENTIONAL",[93],"EARLY_PHASE1","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.",[96,97,98,99],"Voice Disorders","Vocal Fold Polyp","Vocal Nodules in Adults","Muscle Tension Dysphonia","2025-05-07",{"date":102,"type":103},"2025-05-11","ACTUAL",{"date":105,"type":103},"2024-03-01",{"date":107,"type":90},"2029-04-01",{"name":5,"class":6},2]