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

NCT06971640 | Recruiting

• 2 other identifiers: Pro00116918R01MH136425
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD; ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; attention deficit disorder with hyperactivity; circadian rhythm; dim light melatonin onset

Outcome Measures

Primary Outcomes (2)

• 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/out of bed and related sleep metrics. The Garmin Vivosmart 5 will continuously measure movement and heart rate.

  Nightly for 7 nights (at-home assessment)

• 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/mL 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)

Secondary Outcomes (3)

• Sleep disturbances as measured by parent report Children's Sleep Habits Questionnaire (CSHQ)

  Immediately following the study period (up to approximately 2 weeks)

• Sleep routines as measured by the Pediatric Sleep Practices Questionnaire (PSPQ)

  Immediately following the study period (up to approximately 2 weeks)

• Chronotype will be measured by parent report Children's Chronotype Questionnaire (CCTQ)

  Immediately following the study period (up to approximately 2 weeks)

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with ADHD ages 6-9 in the Duke University Health System

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29982088 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34384227 BACKGROUND

• 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.

  PMID: 30796648 BACKGROUND

• 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.

  PMID: 30646132 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Salivary melatonin will be collected. Eleven \~2ml saliva samples will be collected, one every 30 minutes, over a 5 hour period.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jessica Lunsford-Avery, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Gibson

CONTACT

919-681-2521; matthew.gibson646@duke.edu

Jessica Lunsford-Avery, Ph.D.

CONTACT

jessica.r.avery@duke.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: May 14, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be accessible by researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals and questions for data access should be directed to NDAHelp@mail.nih.gov. To gain access, data requestors will need to sign a data access agreement at https://nda.nih.gov/nda/access-data-info.html.

Locations

US (1)