[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623070":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":30,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":94,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Arizona","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Amber Tinted Glasses","EXPERIMENTAL","Wearing \"blue-blocker\" glasses (lenses that filter out the blue portion of the visible spectrum) can reduce the melatonin suppression and alertness effects of evening light exposure in both adults and adolescents, as well as advance the timing of the circadian clock and sleep onset, compared with participants wearing placebo lenses. This intervention will examine their efficacy in advancing young children's sleep and circadian timing. Children will be given a pair of glasses (Block Blue Light), with amber-tinted lenses (advertised as blocking 100% of light from 380-550 nm. Children will wear the glasses starting 1 h before parent's selected bedtime each evening across the two-week intervention. Parents will also complete a daily diary detailing when the glasses are worn.",[13],"Device: Amber Tinted Glasses",{"label":15,"type":16,"description":17,"interventionNames":18},"Clear Glasses","SHAM_COMPARATOR","The sham comparator consists of the same protocols for the amber-tinted glasses, except that children will wear a pair of glasses with clear lenses (advertised as blocking 50% of light from 400-500 nm), which are significantly less effective at blocking short-wavelength light.",[19],"Device: Clear Glasses",{"label":21,"type":10,"description":22,"interventionNames":23},"Smart Lightbulbs","The presence of more blue light in the home is associated with later circadian timing in both school-aged children and adults. This intervention will adjust the evening home lighting environment to be less stimulating to children's circadian clocks. Smart light bulbs (dimmable and color tunable LED bulbs) will be installed in participants' homes light fixtures, or in the child's bedroom, bathroom, as well as areas the child is likely to spend time in after dinner (i.e., living room, playroom). The researchers will program the lights to transition to a lower CCT and dimmer intensity to achieve the recommended evening mEDI of 10 lux starting 1 h before the child's parent-selected bedtime.",[24],"Device: Smart Lightbulbs",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Children will wear amber-tinted glasses in the evening hours before bedtime to reduce exposure to short-wavelength (blue) light. The glasses are intended to reduce circadian disruption associated with evening light exposure.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Children will wear clear glasses in the evening hours before bedtime. This sham intervention controls for wearing glasses without reducing light exposure.",[15],{"type":27,"name":21,"description":35,"armGroupLabels":36,"otherNames":30},"Smart light bulbs will be installed in the child's home and programmed to reduce short-wavelength light exposure during evening hours before bedtime.",[21],[38],{"name":39,"affiliation":5,"role":40},"Lauren E Hartstein, PhD","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},"CONTACT","520-621-1360","laurenhartstein@arizona.edu",[47],{"facility":5,"status":30,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Tucson","Arizona","85724","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-110.92648,32.22174,{"lat":57,"lon":56},[60],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},{"type":62,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[64],{"name":65,"class":66},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100623070","circadian-light-exposure-adjustment-for-restfulness-100623070",false,"NCT07391852","Circadian Light Exposure Adjustment for Restfulness","CLEAR","Inclusion Criteria:\n\n* Inclusion requires that children are aged 5.0-6.9 years at the time of enrollment with a parent-reported sleep onset of ≥ 60 min after parents' desired bedtime at least three nights per week.\n\nOne adult parent of each participating child will also take part in the study. Parents must be able to provide consent for themselves and their child and to complete the interview at the end of the study.\n\nExclusion Criteria:\n\n* Children are excluded for the following reasons:\n\n  * All sleep disorders as indicated on the telephone screener or by clinical cut-off scores on the Children's Sleep Habits Questionnaire (CSHQ), except for insomnia or DSWPD as features of these disorders are directly targeted by the intervention. Secondary analyses will explore if outcomes differ among participants with or without parent-reported symptoms consistent with these diagnoses.\n  * Physical abilities that interfere with assessments (e.g., visual impairment), developmental disabilities (e.g., autism, attention-deficit\u002Fhyperactivity disorder (ADHD), pervasive developmental disorder), epilepsy or other neurological disorders, metabolic disorders, medical conditions that commonly require treatments or assessments during the night (e.g., cancer, diabetes, active asthma), current infection or lead poisoning; a head injury involving loss of consciousness in the past 6 months.\n  * Current use of medications affecting daytime sleepiness, the circadian system, or light sensitivity.\n  * Eye disorders or color blindness (determined with Ishihara Color Vision Test); corrected vision with eyeglasses is permitted.","ALL","60 Months","83 Months",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","Many young children are exposed to light int he evening hours before bedtime. Children's biological clocks are highly sensitive to evening light exposure, which can delay the timing of the clock and make it harder to fall asleep. The purpose of this study is to test three strategies (adjustment to home lighting, amber-tinted glasses, clear glasses) to reduce evening light exposure in children ages 5-6 years with parent-reported sleep onset difficulties in order to improve their sleep and the timing of their biological clock. This study takes place over approximately 5 weeks. After baseline assessments of children's sleep timing, light exposure, cognition, and circadian rhythms, they will be randomly assigned to one of three interventions to reduce evening light exposure for two weeks. After the two-week intervention period, the baseline measures are repeated and parents are interviewed about their and their child's experiences with the intervention.",[85],"Sleep Onset Latency",[87,88,89,90,91,92,93],"Behavioral sleep problems","Circadian phase","sleep onset latency","Early childhood","dim light melatonin onset (DLMO)","Evening light exposure","Light intervention","NOT_YET_RECRUITING","2026-01-29",{"date":97,"type":98},"2026-02-06","ACTUAL",{"date":100,"type":79},"2026-01-15",{"date":102,"type":79},"2030-07-31",{"name":5,"class":6},1]