[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356116":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":24,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":24,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":54,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Wisconsin, Milwaukee","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active EMST + Standard Care","EXPERIMENTAL","Patients randomized to the Active EMST + Standard Care arm (ACTIVE) will use the EMST150 device as packaged, i.e. following package instructions with a device that has its valve spring maintained.",[13],"Other: EMST",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham EMST + Standard Care","SHAM_COMPARATOR","Those randomized to the Sham EMST + Standard Care arm (SHAM) will use an EMST150 device that has been modified by removing the internal spring, which allows the valve to open in response to airflow through the device regardless of the amount of pressure generated.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"EMST","Expiratory muscle strength training (EMST) is an exercise program designed to strengthen the muscles of expiration by increasing expiratory load during breathing exercises using either resistive or pressure threshold devices. The EMST150 is a commercially-available device considered non-significant risk (NSR). The EMST150 device will be used for this study.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Barbara Pauloski","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Barbara Pauloski, Ph.D.","CONTACT","4142296719","pauloski@uwm.edu",{"name":36,"role":32,"phone":24,"phoneExt":24,"email":24},"Stephanie Stevens, M.S.",[38,52],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"University of Wisconsin Milwaukee","ACTIVE_NOT_RECRUITING","Milwaukee","Wisconsin","53211","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-87.90647,43.0389,{"lat":50,"lon":49},{"facility":53,"status":54,"city":41,"state":42,"zip":55,"country":44,"countryCode":45,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Froedtert Hospital","RECRUITING","53226",{"type":47,"coordinates":57},[49,50],{"lat":50,"lon":49},[60],{"name":61,"role":32,"phone":24,"phoneExt":24,"email":24},"Stephanie Stevens, MS",{"type":28,"investigatorFullName":27,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Associate Professor",[65,66],{"name":53,"class":6},{"name":67,"class":6},"Medical College of Wisconsin","100356116","emst-in-patients-undergoing-crt-for-hnca-100356116",false,"NCT03916809","EMST in Patients Undergoing CRT for HNCA","Impact of Expiratory Muscle Strength Training (EMST) on Swallowing Function in Persons Undergoing Radiotherapy With or Without Chemotherapy (CRT) for Cancers of the Head and Neck (HNCA)","Inclusion Criteria:\n\n* New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx;\n* Planned treatment with primary radiotherapy with or without chemotherapy;\n* Age 18 or older and able to provide consent;\n* Ability to use the EMST150 device (hold in mouth and maintain lip seal)\n\nExclusion Criteria:\n\n* Primary surgery to the head and neck (neck dissection is permitted);\n* Unknown primary tumor;\n* Primary cancers of the nasopharynx, paranasal sinuses, salivary glands and skin.\n* Progressive neurologic condition affecting muscle strength (e.g. amyotrophic lateral sclerosis (ALS), Parkinson's disease)\n* Dysphagia not related to HNCA (e.g. unresolved swallowing difficulty post-stroke or post--traumatic brain injury (TBI))\n* Prior history of head and neck radiotherapy","ALL","18 Years",{"count":78,"type":79},30,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on maintenance of safe and efficient oropharyngeal swallow function in persons with cancer of the head and neck (HNCA) undergoing treatment with radiation therapy or chemoradiotherapy (RT\u002FCRT).",[85,86],"Head and Neck Neoplasms","Deglutition Disorders",[88,89,90,91,92],"oropharyngeal cancer","laryngeal cancer","swallow","chemoradiation","expiratory muscle strength training","2024-12-03",{"date":95,"type":96},"2024-12-04","ACTUAL",{"date":98,"type":96},"2017-07-12",{"date":100,"type":79},"2025-08-01",{"name":5,"class":6},2]