Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT02732756
Eligibility Criteria:
Inclusion Criteria:
* Between 14 and 17 years of age.
* Estimated IQ ≥ 70.
* Meet full DSM-5 criteria for ADHD.
* Sufficient English language ability necessary to complete study measures.
* If applicable, the family must be willing to discontinue any treatment with a psychostimulant medication during the three-week sleep manipulation protocol.
Exclusion Criteria:
* Children with an autism spectrum disorder or diagnosed with psychosis, bipolar disorder, or obsessive-compulsive disorder based on the K-SADS diagnostic interview will be excluded.
* Children taking any psychiatric medication that is not a psychostimulant.
* Significant visual, hearing, or speech impairment.
* Organic brain injury or history of seizures.
* Symptoms of obstructive sleep apnea (OSA), periodic limb movement disorder (PLMD), or delayed sleep phase syndrome (DSPS).
* Obligations that require bedtime later than 10pm or waking prior to 5:30am any morning of the study.
* Daily consumption of \>1 coffee or "energy drink" or \>3 caffeinated sodas.
* Highly atypical sleep, defined as \<6 hours or \>9.5 hours on school nights per parent and adolescent report.
* Inability or refusal to refrain from automobile driving or other high-risk tasks that require vigilance during the sleep restriction week of the study.
* Finally, at the visit following the baseline week (week 1) of the sleep protocol, we will exclude teens whose actigraphs reflect an inability to consistently arise within 1 hour of the agreed-upon time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
17 Years
Study:
NCT02732756
Study Brief:
Protocol Section:
NCT02732756