Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD
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|ClinicalTrials.gov Identifier: NCT02897362|
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : May 23, 2019
|Condition or disease|
|Attention Deficit Hyperactivity Disorder|
This project will involve recruitment of 30 adolescents with ADHD and a control group of 30 healthy adolescents without psychiatric diagnoses. Participants will participate in 3 phases: Screening visit, Washout/In-Home Sleep Study, and Neurocognitive Assessment visit. To ensure consistency in sleep schedules, the three nights of the sleep study will occur on weeknights during the school year. The neurocognitive assessment will occur during the afternoon following the final night of sleep assessment.
The 2-hour screening visit will be conducted at the Duke ADHD Clinic at 2608 Erwin Road, Pavilion East, Suite 300, Durham, NC 27705. During the screening visit, participants will undergo screening to evaluate eligibility for the study.
Eligible participants will enter the 48-hour Washout from stimulant medication (if applicable) and/or a 7-day washout from melatonin (if applicable). Following this washout, subjects will enter a 3-night Sleep Study Phase (At Home). Subjects not taking stimulant medication or melatonin will initiate 3 consecutive nights of ambulatory (in-home) PSG recording, beginning on the a Monday evening within 4 weeks of the screening visit. Subjects will be instructed to maintain usual sleep routines/behaviors for all study nights. In addition, subjects will be asked to complete a "sleep diary" each morning.
If subject is currently taking stimulant medication, they will be instructed to initiate a 48-hour washout period. If subject is currently taking melatonin, they will be instructed to initiate a 7-day washout period. Subjects will be instructed to discuss this option with their prescribing physician prior to initiating the study.
Subjects will be asked to return for a three hour neurocognitive assessment on the afternoon directly following the final night of the sleep study. In order to reduce interference with school attendance, this visit will be scheduled in the afternoon. Subjects will take breaks throughout the assessment.
Subjects will restart their ADHD medications on the morning following the neurocognitive assessment (if applicable).
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Adolescents with ADHD
Adolescents, male or female, ages 13-17, confirmed diagnosis of Attention Deficit Hyperactivity Disorder (inattentive, hyperactive/impulsive, or combined presentations), medically healthy, no comorbid psychiatric diagnosis other than ODD, intelligence within normal limits. Participants will complete 3 nights of ambulatory polysomnography at home and a neuropsychological assessment in the lab.
Healthy Control Adolescents
Adolescents, male or female, ages 13-17, medically healthy, no psychiatric diagnoses, intelligence within normal limits. Participants will complete 3 nights of ambulatory polysomnography at home and a neuropsychological assessment in the lab.
- Objective sleep assessment [ Time Frame: 3 consecutive nights ]Ambulatory polysomnographic measures of total sleep time, sleep onset latency, wake after sleep onset, and EEG spectral dynamics.
- Neurocognitive assessment [ Time Frame: 1 day ]Computerized measure of neurocognition.
- Executive functioning as measured by neurocognitive assessment [ Time Frame: 1 day ]Measure of executive function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897362
|Contact: Leah Akins, MScfirstname.lastname@example.org|
|United States, North Carolina|
|Duke Child and Family Study Center||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Jessica R Lunsford-Avery, PhD 919-681-0035 email@example.com|
|Principal Investigator:||Jessica R Lunsford-Avery, PhD||Duke University|