[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06971640":3,"trial-entities:NCT06971640":120,"trial-summary:NCT06971640":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":14,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":39,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":58,"locations":60,"central_contacts":76,"overall_officials":81,"references":84,"see_also_links":119},"NCT06971640","Pro00116918","Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition","RECRUITING","2029-11","2026-05","2026-05-05","2025-05-28","Duke University","OTHER",null,"The purpose of this study is to better understand sleep and circadian functioning in children with ADHD using home-based measures, parent report, and a lab based melatonin assessment. Investigators will also examine how sleep relates to psychiatric health and cognition among children with ADHD. The investigator for this study is Dr. Jessica Lunsford-Avery from the Department of Psychiatry.","Participants will be asked to review and sign a consent form to enroll. As part of the study, participants will:\n\n* Attend three study visits where they will be asked to complete questionnaires and assessments related to their child's attention and behavior, psychiatric health, and sleep habits. One of these visits is a lab-based melatonin assessment at night.\n* Be asked to have their child wear a device (similar to a wrist watch) for a 7-day period. Parents will also be asked to complete an electronic daily diary about their child's sleep.\n* Be asked to have their child wear a skin temperature sensor each evening after dinner until they wake up the next morning.\n* Be asked to use a mattress sensor which measures movement, sleep state, and heart rate.\n\nParticipants will be compensated for their time.",[18,19],"ADHD - Attention Deficit Disorder With Hyperactivity","ADHD",[19,21,22,23],"attention deficit disorder with hyperactivity","circadian rhythm","dim light melatonin onset","OBSERVATIONAL",[],{"count":27,"type":28},250,"ESTIMATED",[],[31,35],{"measure":32,"description":33,"timeFrame":34},"Circadian Rhythm (Sleep Timing)","Wearable sensor data collection includes 3 sensors and supporting materials. The GreenTEG Core sensor will measure changes in core body temperature (CBT) beginning each evening and continuing through the night until morning waking. The Withings Mat will index times in\u002Fout of bed and related sleep metrics. The Garmin Vivosmart 5 will continuously measure movement and heart rate.","Nightly for 7 nights (at-home assessment)",{"measure":36,"description":37,"timeFrame":38},"DLMO - Dim Light Melatonin Onset","Salivary melatonin will be collected during an in-lab assessment, occurring on Friday night following the home assessment. Eleven saliva samples (\\~2ml) will be collected in a darkened environment every 30 min for a period beginning 4 hours before the child's average weeknight bedtime and extending to 1 hour after their average weeknight bedtime as verified by the previous week's sleep diary. The time at which salivary melatonin concentrations exceed 4 pg\u002FmL will be used for determining DLMO. Circadian alignment will be measured via phase angle calculation, or the duration of time between DLMO and average bedtime as recorded by (1) sleep diary and (2) average sleep onset (actigraphy).","Day 8 (second in-person study visit)",[40,44,47],{"measure":41,"description":42,"timeFrame":43},"Sleep disturbances as measured by parent report Children's Sleep Habits Questionnaire (CSHQ)","Total score is the sum of all the scored questions on the CSHQ. The score ranges from 33 to 99, where a score above 41 indicates a pediatric sleep disorder.","Immediately following the study period (up to approximately 2 weeks)",{"measure":45,"description":46,"timeFrame":43},"Sleep routines as measured by the Pediatric Sleep Practices Questionnaire (PSPQ)","The PSPQ provides information about sleep timing and consistency of sleep timing across weekends versus weekdays. The total score is standardized to a T-score with a mean of 50 and a standard deviation of 10.",{"measure":48,"description":49,"timeFrame":43},"Chronotype will be measured by parent report Children's Chronotype Questionnaire (CCTQ)","Chronotypes are natural preferences of the body for wakefulness and sleep. Morning to Evening (M\u002FE) scale-scores range from 10 (extreme morningness) to 49 (extreme eveningness). Morning types are classified by a M\u002FE scale score of ≤23, intermediate types by a score of 24-32, and evening types by a score ≥33.","ALL","6 Years","9 Years",false,{"inclusion":55,"exclusion":56,"raw_text":57},[],[],"Inclusion Criteria:\n\n1. Child ages 6-9\n2. Meet criteria for a primary psychiatric diagnosis of DSM-5 ADHD, any presentation\n3. Intellectual functioning \\>80\n4. Healthy (i.e., no major medical problems)\n5. If applicable, willingness to suspend use of melatonin during the study period\n\nExclusion Criteria:\n\n1. Meet DSM-5 criteria for psychosis, bipolar, or autism spectrum disorders\n2. Diagnosis of occult sleep disorders, including sleep apnea or restless leg syndrome\n3. Medication for sleep other than melatonin\n4. Plans to initiate stimulant medication during the study period",[59],"CHILD",[61],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":73},"Duke University Medical Center","Durham","North Carolina","27705","United States",[68],{"name":69,"role":70,"phone":71,"email":72},"Matt Gibson","CONTACT","919-681-2521","matthew.gibson646@duke.edu",{"lat":74,"lon":75},35.99403,-78.89862,[77,78],{"name":69,"role":70,"phone":71,"email":72},{"name":79,"role":70,"email":80},"Jessica Lunsford-Avery, Ph.D.","jessica.r.avery@duke.edu",[82],{"name":79,"affiliation":12,"role":83},"PRINCIPAL_INVESTIGATOR",[85,89,92,95,98,101,104,107,110,113,116],{"pmid":86,"type":87,"citation":88},"32361211","BACKGROUND","Yektas C, Tufan AE, Sarigedik E. Sleep habits of children diagnosed with attention\u002F deficit\u002F hyperactivity disorder and effects of treatment on sleep related parameters. Asian J Psychiatr. 2020 Aug;52:102045. doi: 10.1016\u002Fj.ajp.2020.102045. Epub 2020 Apr 9.",{"pmid":90,"type":87,"citation":91},"31032953","Becker SP, Langberg JM, Eadeh HM, Isaacson PA, Bourchtein E. Sleep and daytime sleepiness in adolescents with and without ADHD: differences across ratings, daily diary, and actigraphy. J Child Psychol Psychiatry. 2019 Sep;60(9):1021-1031. doi: 10.1111\u002Fjcpp.13061. Epub 2019 Apr 29.",{"pmid":93,"type":87,"citation":94},"29982088","Merikanto I, Lahti J, Kuula L, Heinonen K, Raikkonen K, Andersson S, Strandberg T, Pesonen AK. Circadian preference and sleep timing from childhood to adolescence in relation to genetic variants from a genome-wide association study. Sleep Med. 2018 Oct;50:36-41. doi: 10.1016\u002Fj.sleep.2018.04.015. Epub 2018 Jun 1.",{"pmid":96,"type":87,"citation":97},"25726514","Dalsgaard S, Ostergaard SD, Leckman JF, Mortensen PB, Pedersen MG. Mortality in children, adolescents, and adults with attention deficit hyperactivity disorder: a nationwide cohort study. Lancet. 2015 May 30;385(9983):2190-6. doi: 10.1016\u002FS0140-6736(14)61684-6. Epub 2015 Feb 26.",{"pmid":99,"type":87,"citation":100},"27037707","Peasgood T, Bhardwaj A, Biggs K, Brazier JE, Coghill D, Cooper CL, Daley D, De Silva C, Harpin V, Hodgkins P, Nadkarni A, Setyawan J, Sonuga-Barke EJ. The impact of ADHD on the health and well-being of ADHD children and their siblings. Eur Child Adolesc Psychiatry. 2016 Nov;25(11):1217-1231. doi: 10.1007\u002Fs00787-016-0841-6. Epub 2016 Apr 1.",{"pmid":102,"type":87,"citation":103},"33554324","Chhibber A, Watanabe AH, Chaisai C, Veettil SK, Chaiyakunapruk N. Global Economic Burden of Attention-Deficit\u002FHyperactivity Disorder: A Systematic Review. Pharmacoeconomics. 2021 Apr;39(4):399-420. doi: 10.1007\u002Fs40273-020-00998-0. Epub 2021 Feb 8.",{"pmid":105,"type":87,"citation":106},"30802682","Libutzki B, Ludwig S, May M, Jacobsen RH, Reif A, Hartman CA. Direct medical costs of ADHD and its comorbid conditions on basis of a claims data analysis. Eur Psychiatry. 2019 May;58:38-44. doi: 10.1016\u002Fj.eurpsy.2019.01.019. Epub 2019 Feb 22.",{"pmid":108,"type":87,"citation":109},"23021476","Doshi JA, Hodgkins P, Kahle J, Sikirica V, Cangelosi MJ, Setyawan J, Erder MH, Neumann PJ. Economic impact of childhood and adult attention-deficit\u002Fhyperactivity disorder in the United States. J Am Acad Child Adolesc Psychiatry. 2012 Oct;51(10):990-1002.e2. doi: 10.1016\u002Fj.jaac.2012.07.008. Epub 2012 Sep 5.",{"pmid":111,"type":87,"citation":112},"34384227","Sibley MH, Arnold LE, Swanson JM, Hechtman LT, Kennedy TM, Owens E, Molina BSG, Jensen PS, Hinshaw SP, Roy A, Chronis-Tuscano A, Newcorn JH, Rohde LA; MTA Cooperative Group. Variable Patterns of Remission From ADHD in the Multimodal Treatment Study of ADHD. Am J Psychiatry. 2022 Feb;179(2):142-151. doi: 10.1176\u002Fappi.ajp.2021.21010032. Epub 2021 Aug 13.",{"pmid":114,"type":87,"citation":115},"30796648","Zhao X, Page TF, Altszuler AR, Pelham WE 3rd, Kipp H, Gnagy EM, Coxe S, Schatz NK, Merrill BM, Macphee FL, Pelham WE Jr. Family Burden of Raising a Child with ADHD. J Abnorm Child Psychol. 2019 Aug;47(8):1327-1338. doi: 10.1007\u002Fs10802-019-00518-5.",{"pmid":117,"type":87,"citation":118},"30646132","Xu G, Strathearn L, Liu B, Yang B, Bao W. Twenty-Year Trends in Diagnosed Attention-Deficit\u002FHyperactivity Disorder Among US Children and Adolescents, 1997-2016. JAMA Netw Open. 2018 Aug 3;1(4):e181471. doi: 10.1001\u002Fjamanetworkopen.2018.1471.",[],{"nct_id":4,"conditions":121,"biomarkers":123},[122],"Attention Deficit Hyperactivity Disorder",[],{"nct_id":4,"found":125,"summary":126,"prompt_version":136},true,{"design":127,"status":128,"heading":129,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This is an observational study, meaning it observes participants without providing any specific interventions. It plans to enroll 250 children aged 6 to 9.","completed","Understanding Sleep and Circadian Rhythms in Children with ADHD","This study aims to better understand the connection between sleep patterns (circadian rhythm) and ADHD in children aged 6 to 9. Researchers will look at how sleep affects a child's mental health and thinking abilities. You or your child would participate in three study visits, including one for a melatonin assessment. Your child would also wear a device similar to a wristwatch for 7 nights, and you would complete daily diaries about their sleep. They would also wear a skin temperature sensor and use a mattress sensor. To join, children must have an ADHD diagnosis, good intellectual functioning, and be generally healthy. If your child takes melatonin, you would need to stop its use during the study. The study is currently unclear on its recruitment status and plans to enroll 250 participants.","The primary endpoints, circadian rhythm and dim light melatonin onset (DLMO), are measured over 7 nights and on day 8, respectively. Longer-term follow-up is not specified.",132,"Participants will attend three study visits, complete questionnaires, and have their child wear a wrist device, skin temperature sensor, and use a mattress sensor for 7 nights. Parents will also complete electronic daily diaries.","Participants will be compensated for their time.",[],"v2"]