[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512784":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Night three- sham, night four - active","EXPERIMENTAL","This arm will receive sham auditory stimulation for the first 3 nights and active auditory stimulation for the fourth night.\n\nNight one - sham auditory stimulation, night 2 - sham auditory stimulation, night 3 - sham auditory stimulation, night 4 - active auditory stimulation",[13,14],"Device: Closed-loop auditory stimulation","Device: Sham auditory stimulation",{"label":16,"type":10,"description":17,"interventionNames":18},"Experimental: Night three - active, night four - sham","This arm will receive sham auditory stimulation for the first two nights, active auditory stimulation for the third night, and sham auditory stimulation for the fourth night.\n\nNight one - sham auditory stimulation, night two - sham auditory stimulation, night three - active auditory stimulation, night four - sham auditory stimulation",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Closed-loop auditory stimulation","Closed-loop auditory stimulation will be administered by a wearable EEG device (Philips SmartSleep Deep Sleep Headband). The EEG device will deliver auditory stimulation when slow-wave (deep) sleep is detected. Auditory stimulation will consist of 50ms long tones separated from each other by a fixed one-second inter-tone interval. The volume of each tone will be linearly modulated by sleep-depth such that louder (or softer) tones were played during deeper (or shallower) sleep.",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham auditory stimulation","Sham auditory stimulation consists of closed-loop auditory stimulation not being administered. A wearable EEG device (Philips SmartSleep Deep Sleep Headband) will not deliver closed-loop auditory stimulation and tones will not be played.",[16,9],[31],{"name":32,"affiliation":33,"role":34},"Fabio Ferrarelli, MD,PhD","University of Pittsbrugh","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Chloe A Huston, MA","CONTACT","412-246-6114","hustonca@upmc.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-79.99589,40.44062,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":25,"phoneExt":25,"email":58},"Fabio Ferrarelli, MD, PhD","ferrarellif@upmc.edu",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Fabio Ferrarelli","Associate Professor",[64],{"name":65,"class":66},"National Institute of Mental Health (NIMH)","NIH","100512784","restoring-spindle-and-thalamocortical-efficiency-in-early-course-schizophrenia-patients-using-auditory-stimulation-100512784",false,"NCT05956951","Restoring Spindle and Thalamocortical Efficiency in Early-Course Schizophrenia Patients Using Auditory Stimulation","Restoring Spindle and Thalamocortical Efficiency in Early-Course Schizophrenia Patients Using Closed-Loop Auditory Stimulation","RESPITE","Inclusion Criteria:\n\nEarly-course schizophrenia (EC-SCZ):\n\n1. ages 18-40 years\n2. current DSM-IV defined diagnosis of schizophrenia, schizophreniform or schizoaffective disorder, not drug-induced, with no previously reported psychotic episode\n3. duration of ≤5 years from beginning of psychosis, defined by report of symptoms and\u002For history of treatment according to clinical guidelines employed in our University of Pittsburgh Medical Center (UPMC) psychoses clinics in Pittsburgh\n4. lifetime exposure to antipsychotic medications ≤5 years\n\nHealthy controls (HC):\n\n1. ages 18-40 years\n2. no lifetime history of psychiatric disorders\n3. no first-degree family history of schizophrenia spectrum disorder or mood disorder with psychotic features.\n\nExclusion Criteria:\n\nGeneral exclusion criteria:\n\n1. DSM-IV intellectual disability\n2. significant head injury\n3. medical illness affecting brain function or structure\n4. pregnancy or postpartum (\\\u003C6 weeks after delivery or miscarriage)\n5. significant neurological disorder (e.g. seizure disorder)\n6. inability to provide informed consent\n7. current or past co-morbidity for alcohol or psychoactive substance dependence\n8. substance abuse other than cannabis and\u002For alcohol within the past one year\n\nFor EC-SCZ:\n\na) a psychotic illness with a temporal relation to substance use or head injury\n\nFor healthy controls (HC):\n\n1. difficult falling and\u002For staying asleep for more than half the nights of a week, on average\n2. diagnosis of sleep apnea or restless leg syndrome\n3. sleeping less than 5 hours or more than 10 hours daily, on average",true,"ALL","18 Years","40 Years",{"count":80,"type":81},200,"ESTIMATED","INTERVENTIONAL",[84],"NA","The purpose of this research is to identify differences in brain activity during sleep between health individuals and individuals with schizophrenia, schizophreniform, or schizoaffective disorder. This study will also investigate whether tones played during deep sleep can enhance specific features of sleep and whether enhancing such features is related to an improvement in cognitive performance.",[87],"Schizophrenia","2026-06-03",{"date":90,"type":91},"2026-06-04","ACTUAL",{"date":93,"type":91},"2023-07-20",{"date":95,"type":81},"2028-06",{"name":61,"class":6},1]