[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554033":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":50,"collaborators":24,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":24,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Subjects will undergo 4 weeks of immersive virtual reality exposure using the Aurora Mindfulness app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline, 2-week and 4-week measurement of symptoms using 5 validated instruments.",[13],"Other: Aurora Mindfulness app versus sham",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","SHAM_COMPARATOR","Subjects will undergo 2 weeks of immersive virtual reality exposure using the Aurora Mindfulness sham app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline and 2-week measurement of symptoms using 5 validated instruments.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Aurora Mindfulness app versus sham","It would either immersive virtual reality exposure for the experimental group or non-immersive virtual reality exposure for the placebo group.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Kenny H Chan, MD","CONTACT","720-777-8502","kenny.chan@childrenscolorado.org",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Children's Hospital Colorado","RECRUITING","Aurora","Colorado","80218","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-104.83192,39.72943,{"lat":44,"lon":43},[47,48],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},{"name":27,"role":49,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100554033","mindfulness-application-effects-on-mental-health-symptoms-in-children-with-severe-tinnitus-and-misophonia-100554033",false,"NCT06493825","Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia","Effects of Immersive Virtual Reality Mindfulness Application on Quality of Life, Anxiety and Depression Symptoms in Children With Severe Tinnitus and Misophonia - A Pilot Study","Inclusion Criteria:\n\n* Children between the ages of 10 to 18 years\n* All genders and ethnicities\n* Patients who meet criteria for \"severe\" symptoms of tinnitus and misophonia as scored by TIF and A-MISO-S\n\nExclusion Criteria:\n\n* Severe developmental delay as not to understand verbal instructions necessary to complete the VR application\u002Fsham exposure.\n* Severe visual impairment (refractive disorders are acceptable)\n* Patients with unilateral or bilateral hearing loss of any type.\n* History of seizure disorder",true,"ALL","10 Years","18 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"NA","Children with \"bothersome\" tinnitus and misophonia have elevated anxiety and depression symptoms. The mainstay therapy for adults and children with these disorders is cognitive behavioral therapy (CBT). CBT resources are expensive and scarce for the pediatric population. Immersive virtual reality (IVR) has been shown in the adult population to be a proxy for CBT for several mental health disorders. There is sufficient published evidence that IVR is useful in treating adults with anxiety and depression disorders. However, the evidence in children in treating either anxiety and depression symptoms or disorder is scant. Our group views IVR application as a promising medical device to decrease anxiety and depression scores in children with tinnitus and misophonia disorders.\n\nThis is a randomized placebo control (single-blinded to the study subjects) study in which there will be a 2:1 ratio between the experimental and placebo subjects, receiving either active IVR or placebo exposure. A total of 30 subjects with 20 experimental (10 tinnitus, 10 misophonia subjects) and 10 placebo (5 tinnitus and 5 misophonia subjects) will enroll in this randomized clinical trial. Assessment of change of quality of life, anxiety and depression symptoms will be based on 5 validated instruments.\n\nThe 5 validated instruments are: Tinnitus Functional Index (TFI), Amsterdam Misophonia Scale (A-MIS-S), Pediatric Quality of Life PEDQL), Screen for Child Anxiety Related Emotional Disorders (SCARED) and Short Mood and Feelings Questionnaire (SMFQ).",[71,72],"Tinnitus","Misophonia","2025-04-11",{"date":75,"type":76},"2025-04-16","ACTUAL",{"date":78,"type":76},"2024-09-01",{"date":80,"type":65},"2025-12-15",{"name":5,"class":6},1]