[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vocal-nodules-in-adults\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vocal-nodules-in-adults":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Voice Disorders","Vocal Fold Polyp","Vocal Nodules in Adults","Muscle Tension Dysphonia","RECRUITING","2025-05-07",{"date":34,"type":35},"2025-05-11","ACTUAL",{"date":37,"type":35},"2024-03-01",{"date":39,"type":21},"2029-04-01",{"name":41,"class":42},"Massachusetts General Hospital","OTHER",2]