ADHD - Attention Deficit Disorder With HyperactivityCIRCANCT06971640
Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
An observational study of ADHD - Attention Deficit Disorder With Hyperactivity and ADHD, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity, ADHD
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2025to Nov 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with ADHD ages 6-9 in the Duke University Health System
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Lunsford-Avery, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Matt Gibson, 919-681-2521, matthew.gibson646@duke.edu
About this study
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.
Read the detailed description
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.
- Keywords
- ADHD, attention deficit disorder with hyperactivity, circadian rhythm, dim light melatonin onset
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day 8 (second in-person study visit)
Secondary outcomes (3)
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.
Measured: Immediately following the study period (up to approximately 2 weeks)
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.
Measured: Immediately following the study period (up to approximately 2 weeks)
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/E) scale-scores range from 10 (extreme morningness) to 49 (extreme eveningness). Morning types are classified by a M/E scale score of ≤23, intermediate types by a score of 24-32, and evening types by a score ≥33.
Measured: Immediately following the study period (up to approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start28 May 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jessica Lunsford-Avery, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971640
- Sponsor's protocol ID
- Pro00116918
- Other IDs
- R01MH136425
- Acronym
- CIRCA
- Status last verified
- May 2026
- First submitted
- 11 Mar 2025
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: RTI International will be involved in deidentified data analysis.
Publications
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.
PubMed 32361211Becker 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.
PubMed 31032953Merikanto 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.
PubMed 29982088Dalsgaard 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.
PubMed 25726514Peasgood 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.
PubMed 27037707Chhibber 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.
PubMed 33554324Libutzki 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.
PubMed 30802682Doshi 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.
PubMed 23021476Sibley 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.
PubMed 34384227Zhao 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.
PubMed 30796648Xu 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.
PubMed 30646132