[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477077":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":81,"collaborators":85,"id":89,"slug":18,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":18,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":18,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":111,"overallStatus":52,"whyStopped":18,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Expiratory Muscle Strength Training + No Maintenance Training","EXPERIMENTAL","These participants were initially randomized to complete 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":16,"description":17,"interventionNames":18},"No Exercises","NO_INTERVENTION","These participants were initially randomized to 6-8 weeks of no exercises. They ended active study participation after the initial 6-8 weeks of no exercises. They were not eligible to be randomized to maintenance training or no maintenance training.",null,{"label":20,"type":10,"description":21,"interventionNames":22},"Expiratory Muscle Strength Training + Maintenance Training","These participants were initially randomized to complete 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.",[13,23],"Device: Maintenance Training",{"label":25,"type":10,"description":26,"interventionNames":27},"Expiratory Muscle Strength Training","These participants were initially randomized to complete 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],[29,35],{"type":30,"name":25,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[25,20,9],[34],"EMST-150",{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":18},"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)",[20],[40],{"name":41,"affiliation":5,"role":42},"Noel Jabbour, MD","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":18,"email":48},"Amber D Shaffer, PhD","CONTACT","412-692-6874","shafferad@upmc.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"UPMC Children's Hospital of Pittsburgh","RECRUITING","Pittsburgh","Pennsylvania","15224","United States",{"type":58,"coordinates":59},"Point",[60,61],-79.99589,40.44062,{"lat":61,"lon":60},[64,65,69,72,74,76,78,80],{"name":45,"role":46,"phone":47,"phoneExt":18,"email":48},{"name":66,"role":46,"phone":67,"phoneExt":18,"email":68},"Marina V Rushchak, BA","412-692-9879","rushchakmv4@upmc.edu",{"name":70,"role":71,"phone":18,"phoneExt":18,"email":18},"Cuneyt Alper, MD","SUB_INVESTIGATOR",{"name":73,"role":71,"phone":18,"phoneExt":18,"email":18},"Fendi Obuekwe",{"name":75,"role":71,"phone":18,"phoneExt":18,"email":18},"Matthew Ford, MS",{"name":77,"role":71,"phone":18,"phoneExt":18,"email":18},"Jesse Goldstein, MD",{"name":79,"role":71,"phone":18,"phoneExt":18,"email":18},"Nancy Gauvin, PhD",{"name":41,"role":42,"phone":18,"phoneExt":18,"email":18},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Noel Jabbour","Associate Professor",[86],{"name":87,"class":88},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","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* Pittsburgh weighted speech scores of 5 or greater\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)\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":99,"type":100},30,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106,107,108,109,110],"Velopharyngeal Insufficiency","Velopharyngeal Incompetence Due to Cleft Palate","Inadequate Velopharyngeal Closure","Palatopharyngeal Incompetence","Hypernasality",[112,113],"Cleft Palate","Speech Intelligibility","2025-07-17",{"date":116,"type":117},"2025-07-22","ACTUAL",{"date":119,"type":117},"2025-03-03",{"date":121,"type":100},"2027-11",{"name":83,"class":6},1]