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

May 4, 2026 updated by: Duke University
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Child ages 6-9
  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:

  1. Meet DSM-5 criteria for psychosis, bipolar, or autism spectrum disorders
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circadian Rhythm (Sleep Timing)
Time Frame: Nightly for 7 nights (at-home assessment)
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
Time Frame: Day 8 (second in-person study visit)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep disturbances as measured by parent report Children's Sleep Habits Questionnaire (CSHQ)
Time Frame: Immediately following the study period (up to approximately 2 weeks)
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)
Sleep routines as measured by the Pediatric Sleep Practices Questionnaire (PSPQ)
Time Frame: Immediately following the study period (up to approximately 2 weeks)
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.
Immediately following the study period (up to approximately 2 weeks)
Chronotype will be measured by parent report Children's Chronotype Questionnaire (CCTQ)
Time Frame: Immediately following the study period (up to approximately 2 weeks)
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.
Immediately following the study period (up to approximately 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Jessica Lunsford-Avery, Ph.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2025

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

May 6, 2025

First Posted (Actual)

May 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00116918
  • R01MH136425 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

RTI International will be involved in deidentified data analysis.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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