[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285658":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":81,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Device Group","EXPERIMENTAL","The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with PD. FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for CBT or lower acceptability for long-term medication use for adolescent PD. In this pilot intervention study, the efficacy of the FBS system in youth will be tested.",[13],"Device: Freespira Breathing System",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","The device will be given to those in the control group after 8-week baseline period.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Freespira Breathing System","Over an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.",[9],[26],{"name":27,"affiliation":5,"role":28},"Marco Grados, M.D., M.P.H.","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Marco A Grados, M.D., M.P.H.","CONTACT","443-287-2292","mgrados1@jhmi.edu",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Mary Chen","443-390-8494","mchen117@jhmi.edu",[40],{"facility":5,"status":18,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":18},"Baltimore","Maryland","21218","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-76.61219,39.29038,{"lat":50,"lon":49},{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[55],{"name":56,"class":57},"Palo Alto Health Sciences, Inc.","INDUSTRY","100285658","the-use-of-a-fda-cleared-drug-free-breathing-system-for-anxiety-and-panic-disorders-in-children-and-teens-100285658",false,"NCT02998502","The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens","Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders","Inclusion Criteria:\n\n* SCARED score ≥ 25 + prior clinical diagnosis of an anxiety disorder\n* Participants must be 9-17 years of age\n* If on psychotropic medication(s), participant must be on a stable dose for at least one month prior to study enrollment\n\nExclusion Criteria:\n\n* Anxiety has occurred exclusively during a major depressive episode, psychiatric illness, dementia, intellectual disability, or brain disease\n* Currently enrolled in another device or drug study or less than 30 days has elapsed since participation in such a study\n* Currently undergoing breathing biofeedback elsewhere\n* Demonstrate evidence of severe suicidal ideation or psychosis\n* There is an active condition of asthma","ALL","9 Years","17 Years",{"count":69,"type":70},73,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study will test the efficiency of the Freespira Breathing System in youth.",[76,77],"Anxiety","Panic Disorder",[79,76,80],"Obsessive Compulsive Disorder (OCD)","Pediatrics","NOT_YET_RECRUITING","2026-03-05",{"date":84,"type":85},"2026-03-09","ACTUAL",{"date":87,"type":70},"2026-08-01",{"date":89,"type":70},"2027-03-01",{"name":5,"class":6},1]