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

Duke University

Status: Enrolling

Conditions: ADHD - Attention Deficit Disorder With Hyperactivity; ADHD

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06971640

R01MH136425 (U.S. NIH Grant/Contract)

Pro00116918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

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