Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
NCT ID: NCT06971640
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2025-05-28
2029-11-30
Brief Summary
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Detailed Description
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* 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.
* 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.
* Be asked to have their child wear a skin temperature sensor each evening after dinner until they wake up the next morning.
* Be asked to use a mattress sensor which measures movement, sleep state, and heart rate.
Participants will be compensated for their time.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
2. Meet criteria for a primary psychiatric diagnosis of DSM-5 ADHD, any presentation
3. Intellectual functioning \>80
4. Healthy (i.e., no major medical problems)
5. If applicable, willingness to suspend use of melatonin during the study period
Exclusion Criteria
2. Diagnosis of occult sleep disorders, including sleep apnea or restless leg syndrome
3. Medication for sleep other than melatonin
4. Plans to initiate stimulant medication during the study period
6 Years
9 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Jessica Lunsford-Avery, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Yektas C, Tufan AE, Sarigedik E. Sleep habits of children diagnosed with attention/ deficit/ hyperactivity disorder and effects of treatment on sleep related parameters. Asian J Psychiatr. 2020 Aug;52:102045. doi: 10.1016/j.ajp.2020.102045. Epub 2020 Apr 9.
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/jcpp.13061. Epub 2019 Apr 29.
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/j.sleep.2018.04.015. Epub 2018 Jun 1.
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/S0140-6736(14)61684-6. Epub 2015 Feb 26.
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/s00787-016-0841-6. Epub 2016 Apr 1.
Chhibber A, Watanabe AH, Chaisai C, Veettil SK, Chaiyakunapruk N. Global Economic Burden of Attention-Deficit/Hyperactivity Disorder: A Systematic Review. Pharmacoeconomics. 2021 Apr;39(4):399-420. doi: 10.1007/s40273-020-00998-0. Epub 2021 Feb 8.
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/j.eurpsy.2019.01.019. Epub 2019 Feb 22.
Doshi JA, Hodgkins P, Kahle J, Sikirica V, Cangelosi MJ, Setyawan J, Erder MH, Neumann PJ. Economic impact of childhood and adult attention-deficit/hyperactivity disorder in the United States. J Am Acad Child Adolesc Psychiatry. 2012 Oct;51(10):990-1002.e2. doi: 10.1016/j.jaac.2012.07.008. Epub 2012 Sep 5.
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/appi.ajp.2021.21010032. Epub 2021 Aug 13.
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/s10802-019-00518-5.
Xu G, Strathearn L, Liu B, Yang B, Bao W. Twenty-Year Trends in Diagnosed Attention-Deficit/Hyperactivity Disorder Among US Children and Adolescents, 1997-2016. JAMA Netw Open. 2018 Aug 3;1(4):e181471. doi: 10.1001/jamanetworkopen.2018.1471.
Other Identifiers
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Pro00116918
Identifier Type: -
Identifier Source: org_study_id
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