[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599263":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":55,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Individualized Sleep Intervention","EXPERIMENTAL","The intervention involves a structured intervention education session soon after enrollment, where participants receive tailored and personalized instructions for sleep health and quality, then complete daily adherence surveys, and receive follow-up support to address any barriers. The approach builds on prior work to address cognitive and emotional challenges commonly experienced by adolescents with concussion.",[13],"Behavioral: Sleep Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard-of-Care","NO_INTERVENTION","Participants in the standard-of-care group will receive verbal and written sleep hygiene instructions at Visit 1, following established concussion management guidelines. These materials emphasize maintaining a consistent bedtime and reducing screen time before bed to support recovery. The approach reflects best practices informed by clinical recommendations for post-concussion care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Sleep Intervention","The investigators will randomly assign participants (adolescents with concussion) to a personalized sleep schedule and sleep health recommendation, based on a meeting with an administrator after enrollment and randomization. They will undergo testing prior to the intervention, after the intervention (2 weeks after the initial visit, intervention length=2 weeks), and 6 weeks after intervention completion.",[9],[26],{"name":27,"affiliation":28,"role":29},"David R Howell, PhD","University of Colorado Denver | Anschutz","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","7207771502","David.Howell@CUAnschutz.edu",{"name":36,"role":32,"phone":33,"phoneExt":18,"email":37},"Katelyn Hurlburt, BS","Katelyn.Hurlburt@CUAnschutz.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Colorado Denver","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-104.83192,39.72943,{"lat":51,"lon":50},[54],{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100599263","multidimensional-sleep-health-intervention-to-optimize-concussion-recovery-100599263",false,"NCT07082218","Multidimensional Sleep Health Intervention to Optimize Concussion Recovery","Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial","SCORE","Inclusion Criteria:\n\n* Participants will be symptomatic at the time of enrollment (Post-Concussion Symptom Inventory \\[PCSI\\] score ≥9)\n* Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria\n* 10-19 years of age (aligned with World Health Organization definition of 'adolescent')\n\nExclusion Criteria:\n\n* History of treatment for pre-concussion sleep-related disorders","ALL","10 Years","19 Years",{"count":69,"type":70},54,"ESTIMATED","INTERVENTIONAL",[73],"NA","Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.",[76,77,78,79,80],"Concussion (Diagnosis)","Concussion, Mild Traumatic Brain Injury","Treatment","Sleep Health","Depression, Anxiety",[82,83,84],"intervention","mild traumatic brain injury","sleep quality","2026-06-17",{"date":87,"type":88},"2026-06-18","ACTUAL",{"date":90,"type":88},"2025-09-10",{"date":92,"type":70},"2027-06-15",{"name":5,"class":6},1]