[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641619":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":49,"collaborators":19,"id":51,"slug":19,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":19,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":76,"whyStopped":19,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Virginia Commonwealth University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Apollo Neuro device","EXPERIMENTAL","Wearing of activated Apollo Neuro device for at least three hours\u002Fday for 30 of 35 consecutive days by Autistic children with SIB and sensory over and\u002For under responsivity.",[13],"Device: Apollo Neuro device",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Child participants will wear the activated device for a minimum of three hours per day on at least 30 of 35 consecutive days, consistent with the study protocol. The device is worn externally (e.g., wrist, ankle, or waist) and delivers low intensity vibrations through intact skin.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Stacey Reynolds","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Laura Lee Robins","CONTACT","(757) 285-3486","robinslp@vcu.edu",[31],{"facility":32,"status":19,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Virginia Commonwealth Uniersity","Richmond","Virginia","23298","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-77.46026,37.55376,{"lat":42,"lon":41},[45,48],{"name":46,"role":27,"phone":47,"phoneExt":19,"email":29},"Laura Robins","757-541-8460",{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":50,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100641619",false,"NCT07648420","Using Apollo Neuro in Autistic Children With Self-Injurious Behavior","Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior","Inclusion Criteria for child:\n\n* Diagnosis of autism spectrum disorder (ASD), as reported by caregiver\n* Presence of self-injurious behavior, as reported by caregiver\n* Demonstrates sensory over and\u002For under- responsivity\n* Aged 6 years to 14 years, 11 months (179 months) at the time of enrollment\n* Has a caregiver willing and able to provide consent and participate in study procedures\n\nExclusion Criteria for child:\n\n* Has medical condition that may increase risk with use of a wearable nibrotactile device, including:\n\n  * implanted medical or neurological devices (e.g., pacemaker)\n  * significant cardiac conditions or arrhythmias\n  * history of syncope (fainting)\n* Known seizure disorder without physician clearance\n* Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days\n* Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures\n\nInclusion Criteria for Caregiver:\n\n* Parent or legal guardian of the enrolled child participant\n* Able to provide informed consent in English\n* Able and willing to support device use according to study protocol and complete study-related data collection\n* Has access to a smartphone or compatible device capable of operating the Apollo Neuro application for the duration of study period\n\nExclusion Criteria for Caregiver:\n\n• Unable to provide informed consent in English","ALL","6 Years","179 Months",{"count":61,"type":62},18,"ESTIMATED","INTERVENTIONAL",[65],"NA","This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self-injurious behavior (SIB).\n\nParticipants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self- injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.",[68,69],"Self-Injurious Behavior","Autism Spectrum Disorder",[71,72,73,74,75],"Apollo Neuro Device","Sensory Responsivity","Autonomic Regulation","Wearable Device","Vibrotactile Stimulation","NOT_YET_RECRUITING","2026-06-15",{"date":79,"type":80},"2026-06-17","ACTUAL",{"date":82,"type":62},"2026-07",{"date":84,"type":62},"2026-11",{"name":5,"class":6},1]