[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477077":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":78,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":34,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":34,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":48,"whyStopped":34,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Expiratory Muscle Strength Training + No Maintenance Training","EXPERIMENTAL","These participants completed 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of no maintenance training.",[13],"Device: Expiratory Muscle Strength Training",{"label":15,"type":10,"description":16,"interventionNames":17},"Expiratory Muscle Strength Training + Maintenance Training","These participants completed 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of maintenance training.",[13,18],"Device: Maintenance Training",{"label":20,"type":10,"description":21,"interventionNames":22},"Expiratory Muscle Strength Training","These participants completed 6-8 weeks of exercises with EMST-150. They did not have improvement in their CAPS-A hypernasality rating of 1 point or more and ended active study participation after the initial 6-8 weeks of exercises.",[13],[24,30],{"type":25,"name":20,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","At visit 1, participants will be block randomized based on PWSS score (5-6 or 7+) to Expiratory Muscle Strength Training (EMST) for 6 to 8 weeks or no exercises. Participants in the EMST-150 group will perform 5 sets of 5 resistive expirations once a day with a 10-15 second rest between each repetition and a 1-2 minute rest between each set of 5 repetitions.",[20,15,9],[29],"EMST-150",{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Maintenance Training","At visit 2, participants with improved (decreased) CAPS-A hypernasality rating of 1 or more points, for whom the family and\u002For surgeon is not currently considering surgical intervention for VPI, will be further randomized to continue \"maintenance\" EMST exercises or no exercises for 6 months. Participants in the \"maintenance\" group will complete 3-5 sessions exercise sessions each week (rather than daily training), with 2 sets of 5 resistive expirations (rather than 5 sets)",[15],null,[36],{"name":37,"affiliation":5,"role":38},"Noel Jabbour, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},"Amber D Shaffer, PhD","CONTACT","412-692-6874","shafferad@upmc.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"UPMC Children's Hospital of Pittsburgh","RECRUITING","Pittsburgh","Pennsylvania","15224","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-79.99589,40.44062,{"lat":58,"lon":57},[61,62,66,69,71,73,75,77],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},{"name":63,"role":42,"phone":64,"phoneExt":34,"email":65},"Marina V Rushchak, BA","412-692-9879","rushchakmv4@upmc.edu",{"name":67,"role":68,"phone":34,"phoneExt":34,"email":34},"Cuneyt Alper, MD","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":34,"phoneExt":34,"email":34},"Fendi Obuekwe",{"name":72,"role":68,"phone":34,"phoneExt":34,"email":34},"Matthew Ford, MS",{"name":74,"role":68,"phone":34,"phoneExt":34,"email":34},"Jesse Goldstein, MD",{"name":76,"role":68,"phone":34,"phoneExt":34,"email":34},"Nancy Gauvin, PhD",{"name":37,"role":38,"phone":34,"phoneExt":34,"email":34},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Noel Jabbour","Associate Professor",[83],{"name":84,"class":85},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100477077","expiratory-muscle-strength-training-for-hypernasal-speech-in-children-100477077",false,"NCT05492266","Expiratory Muscle Strength Training for Hypernasal Speech in Children","Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial","Inclusion Criteria:\n\n* Score of 2 or greater on the nasality\u002Fresonance domain of the Pittsburgh Weighted Speech Scale\n* Ages 5-17 years\n\nExclusion Criteria:\n\n* CAPS-A-AM hypernasality score \\\u003C2\n* Previous speech surgery (e.g. palatoplasty or pharyngeal flap for speech)\n* Speech surgery scheduled within the next 56 days\n* Unable or unwilling to perform the tests and exercises outlined in the study","ALL","5 Years","17 Years",{"count":97,"type":98},30,"ESTIMATED","INTERVENTIONAL",[101],"NA","When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. The purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.",[104,105,106,107,108],"Velopharyngeal Insufficiency","Velopharyngeal Incompetence Due to Cleft Palate","Inadequate Velopharyngeal Closure","Palatopharyngeal Incompetence","Hypernasality",[110,111],"Cleft Palate","Speech Intelligibility","2026-07-16",{"date":114,"type":115},"2026-07-20","ACTUAL",{"date":117,"type":115},"2025-03-03",{"date":119,"type":98},"2027-11",{"name":80,"class":6},1]