[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487292":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":39,"responsibleParty":60,"collaborators":10,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":10,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":10,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group- Without Phonotrauma",null,"Videoendoscopy and acoustic recordings using a head-mounted microphone with a voice-specialized SLP for participants without voice disorders, acoustic recordings will involve the five repetitions of three vowels (\u002Fɑ, i, u\u002F) and a standard reading passage (Rainbow Passage) in three voice conditions (breathy, typical, and pressed). For all participants, high-speed videoendoscopy and simultaneous acoustic recording will occur on one repetition of a sustained \u002Fi\u002F in each requested condition.",[13],"Diagnostic Test: Acoustic voice analysis",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients Diagnosed with Phonotrauma","Videoendoscopy and acoustic recordings using a head-mounted microphone with a voice-specialized SLP for Participants who have a diagnosis of phonotrauma will be instructed to produce five repetitions of the same three vowels but in only two conditions: typical voice and \"resonant\" voice following stimulability assessment and with cues. They will be instructed to maintain relatively consistent volume and pitch across conditions. For all participants, high-speed videoendoscopy and simultaneous acoustic recording will occur on one repetition of a sustained \u002Fi\u002F in each requested condition.",[18],"Diagnostic Test: High-speed videoendoscopy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Acoustic voice analysis","Acoustic recordings will involve the five repetitions of three vowels (\u002Fɑ, i, u\u002F) and a standard reading passage (Rainbow Passage) in different voice conditions. Control participants will produce voice in breathy, typical, and pressed conditions. Patient participants will produce voice in typical production and in a resonant voice production. High-speed videoendoscopy and simultaneous acoustic recording will occur on one repetition of a sustained \u002Fi\u002F in each requested condition. Data will be collected using a head-mounted microphone.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"High-speed videoendoscopy","High-speed videoendoscopy will occur on one repetition of a sustained \u002Fi\u002F in each requested condition. Exams will be recorded using the Phantom V311 high-speed camera (Vision Research, Wayne, NJ) connected to a Storz 70° rigid laryngoscope using a 400 Watt Xenon light source (Titan 400E).",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Laura Toles, PhD","CONTACT","214-645-2943","Laura.Toles@UTSouthwestern.edu",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Paula Arellano-Cruz","214-648-8096","paula.arellano-cruz@utsouthwestern.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75235","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-96.80667,32.78306,{"lat":52,"lon":51},[55,58],{"name":56,"role":32,"phone":57,"phoneExt":10,"email":34},"Laura Toles","2146452943",{"name":36,"role":32,"phone":59,"phoneExt":10,"email":38},"2146488096",{"type":61,"investigatorFullName":31,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Assistant Professor","100487292","patients-with-and-without-phonotrauma-100487292",false,"NCT05625191","Patients With and Without Phonotrauma","Defining Clinically Important Differences in Cepstral and Spectral Measures in Individuals With and Without Phonotrauma","Control Group:\n\nInclusion Criteria:\n\n1. 18-65 years of age (to avoid confounding physiological factors related to puberty or presbyphonia)\n2. No history of or current voice disorder\n3. Auditory perceptual presentation globally within functional limits (as determined by a voice specialized SLP).\n\nExclusion Criteria:\n\n1. Atypical auditory-perceptual voice presentation\n2. History of voice disorder or laryngeal surgery.\n\nPatient Group:\n\nInclusion Criteria:\n\n1. Diagnosed with phonotrauma (i.e., vocal fold nodules, vocal fold polyp, vocal fold pseudocyst, mid-fold edema) by a laryngologist.\n2. 18-65 years of age\n\nExclusion Criteria:\n\n1. Diagnosis of voice disorder not related to phonotrauma (e.g., vocal fold immobility, laryngeal dystonia, primary muscle tension dysphonia, etc.)\n2. Previous history of laryngeal surgery or voice therapy (to avoid confounding effects of previous treatment).",true,"ALL","18 Years","65 Years",{"count":75,"type":76},100,"ESTIMATED","OBSERVATIONAL","There is a substantial need to identify objective measures associated with hyperadduction of the vocal folds to recognize those at higher risk of developing phonotrauma so that risk mitigation strategies can be implemented before phonotrauma develops. The overall objective of this proposed project is to investigate the sensitivity and direction of change in cepstral peak prominence (CPP) and the magnitude difference between the first two harmonics of the voice spectrum (H1-H2) in response to varied phonation patterns, which will be addressed using the following two aims:\n\nAim 1: Determine how CPP and H1-H2 change as a function of using pressed voice production in individuals without laryngeal pathology.\n\nAim 2: Examine the sensitivity (minimally detectable change) and responsiveness (minimal clinically important difference) of CPP and H1-H2 to detect changes in different voice production conditions.",[80],"Phonotrauma","2026-06-09",{"date":83,"type":84},"2026-06-11","ACTUAL",{"date":86,"type":84},"2023-01-17",{"date":88,"type":76},"2026-12-31",{"name":5,"class":6},1]