[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554927":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":12,"centralContacts":35,"locations":45,"responsibleParty":65,"collaborators":12,"id":69,"slug":12,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":12,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":12,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":48,"whyStopped":12,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1: standard of care","NO_INTERVENTION","10 children will be enrolled in the first phase related to determining if using actigraphy and timed saliva melatonin samples can be a feasible way to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old while they receive routine critical care.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Phase 2: Daytime light exposure","EXPERIMENTAL","10 children will undergo the same sleep monitoring and salivary melatonin sampling as phase 1 while receiving timed exposure to a light box of 10,000 lux within 3 feet of their hospital bed for PICU days #2, 3 and 4.",[18],"Other: Daytime light exposure",{"label":20,"type":15,"description":21,"interventionNames":22},"Phase 3: Daytime restricted feeding","10 children will undergo the same sleep monitoring and salivary melatonin sampling as phase 1 while attempting to limit all nutrition (parental or enteral) to being provided during the normal hours that the child is awake at home on PICU days #2, 3, 4.",[23],"Other: Daytime restricted feeding",[25,31],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Daytime light exposure","Participants will be exposed to a 10,000 lux light source within 3 feet of their face\u002Feyes to promote the natural circadian rhythm for 2-3 hours from 10am to 12\u002F1pm depending on their nap time at home",[14],[30],"Light therapy",{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":12},"Daytime restricted feeding","Participant's nutrition, parenteral or enteral, will be restricted to the hours when they are normally awake at home.",[20],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":12,"email":40},"Amanda B Hassinger, MD","CONTACT","716-323-0158","albrooks@buffalo.edu",{"name":42,"role":38,"phone":43,"phoneExt":12,"email":44},"Haiping Qiao, MS","716-323-0055","hqiao@upa.chob.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"John R. Oishei Children's Hospital","RECRUITING","Buffalo","New York","14203","United States",{"type":54,"coordinates":55},"Point",[56,57],-78.87837,42.88645,{"lat":57,"lon":56},[60,63],{"name":61,"role":38,"phone":62,"phoneExt":12,"email":40},"Amanda B Hassinger, MD, MSc","716-323-0370",{"name":64,"role":38,"phone":43,"phoneExt":12,"email":44},"Haiping Qiao",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Amanda B. Hassinger","Clinical Associate Professor of Pediatric Sleep Medicine","100554927",false,"NCT06505447","PICU-related Sleep and Circadian Dysregulation Pilot Study","A Three-phase Pilot Study of the Feasibility of the Measurement and Promotion of Sleep and the Circadian Rhythm in a Pediatric Intensive Care Unit","Inclusion Criteria:\n\n1. Child age 3 to 6 years old on the day of PICU admission\n2. English-speaking parent at the bedside\n3. Child expected to remain in the PICU over 24 to 48 hours\n\nExclusion Criteria:\n\n1. Child is in end-of-life care\n2. The child is receiving neuromuscular blockade for any reason\n3. Caregiver or parent not at the bedside","ALL","3 Years","6 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"NA","A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old. This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours.",[86,87,88,89],"Circadian Dysrhythmia","Sleep Disturbance","Critical Illness","Children, Only",[91,92,93,94],"Sleep disruption","circadian rhythm","critical care","pediatrics","2026-03-18",{"date":97,"type":98},"2026-03-23","ACTUAL",{"date":100,"type":98},"2024-12-06",{"date":102,"type":80},"2027-01-01",{"name":5,"class":6},1]