Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition

Обзор

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.

Подробное описание

Participants will be asked to review and sign a consent form to enroll. As part of the study, participants will:

* 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.

Первичные конечные точки

• Circadian Rhythm (Sleep Timing) [Срок оценки: Nightly for 7 nights (at-home assessment)]
• DLMO - Dim Light Melatonin Onset [Срок оценки: Day 8 (second in-person study visit)]

Вторичные конечные точки (3)

• Sleep disturbances as measured by parent report Children's Sleep Habits Questionnaire (CSHQ) [Срок оценки: Immediately following the study period (up to approximately 2 weeks)]
• Sleep routines as measured by the Pediatric Sleep Practices Questionnaire (PSPQ) [Срок оценки: Immediately following the study period (up to approximately 2 weeks)]
• Chronotype will be measured by parent report Children's Chronotype Questionnaire (CCTQ) [Срок оценки: Immediately following the study period (up to approximately 2 weeks)]

Критерии участия

Критерии включения

• Child ages 6-9
• Meet criteria for a primary psychiatric diagnosis of DSM-5 ADHD, any presentation
• Intellectual functioning >80
• Healthy (i.e., no major medical problems)
• If applicable, willingness to suspend use of melatonin during the study period

Критерии исключения

• Meet DSM-5 criteria for psychosis, bipolar, or autism spectrum disorders
• Diagnosis of occult sleep disorders, including sleep apnea or restless leg syndrome
• Medication for sleep other than melatonin
• Plans to initiate stimulant medication during the study period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• Duke University Medical Center — Durham

Публикации

• 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. PMID 32361211
• 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. PMID 31032953
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• 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. PMID 25726514
• 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. PMID 27037707
• 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. PMID 33554324
• 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. PMID 30802682
• 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. PMID 23021476

Идентификаторы

NCT: NCT06971640 · Pro00116918 · R01MH136425

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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