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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00867451
Eligibility Criteria:
Inclusion Criteria:
* Consent: The family must provide signature of informed consent by parents or legal guardians
* Assent: Children must provide assent to participate in the study (via signature on assent form)
* Age at time of Screening: 6 years to 12 years, inclusive
* Gender: includes male and female children.
* ADHD Diagnostic Status: The primary criterion is that patients must meet DSM-IV criteria for ADHD.
* Presence of Significant Sleep Problems: Assessed through clinical history and a commonly used parent-report of children's sleep habits. A cut-off score of or greater than 41 on the Children's Sleep Habits Questionnaire (CSHQ) will be used.
* Functioning at appropriate grade level for age.
Exclusion Criteria:
* Understanding Level: The parent is not fluent in the language of the wording used in the consent form.
* Exclusionary Psychiatric Conditions or Current Significant Stressors: Children whose primary diagnosis is something other than ADHD will be excluded from participation (e.g., oppositional defiant disorder, anxiety). Further, events that have occurred over the past 6 months that could affect sleep (such as active grieving) will also be excluded from participation.
* Developmental Disabilities: Functioning below grade level for age; or as a result of scores on the IQ screening, additional assessments, or the judgment of the study clinicians, patients will be excluded if they are deemed to be significantly developmentally delayed. This includes clinically significant delays in cognitive function or the presence of other Pervasive Developmental Disorders (PDD).
* Organic Brain Injury: Children must not have a history of head trauma (requiring hospitalization), neurological disorder (such as Tourette syndrome, or restless leg movements), or any other organic disorder that could possibly affect brain function.
* Strong evidence of sleep apnea: As determined by cutoff scores on the sleep habits questionnaire. Raw scores of or greater than 6 on relevant items from the CHSQ are often used to indicate sleep apnea.
* Caffeine consumption: is greater than 3 cans per day
* Stimulant or psychotropic medications: Children must be on a stable dose one week prior to the initiation of the study interventions and not require changes or addition of new medication during the intervention time.
* ADHD Medications:Children must be on a stable dose one week prior to the initiation of the study interventions and not require changes or addition of new medication during the intervention time.
* Child-bearing potential: Female subjects who are randomized to the treatment group and who are potentially able to become pregnant, must be willing to take adequate precautions to prevent pregnancy, as determined by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT00867451
Study Brief:
Protocol Section:
NCT00867451