Clinical trial NCT02897362: Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD
Official title: Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Sleep
Adolescents
Neurocognition
Polysomnography
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-09-13
Enrollment: 62
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with ADHD and healthy control adolescents

Brief summary: This study seeks to characterize sleep physiology in adolescents with and without Attention deficit hyperactivity disorder (ADHD) and its relationship to differential neurocognitive and clinical outcomes within these groups.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Male or Female
* Between the ages of 13-17 years, inclusive;
* Free from significant medical/psychiatric conditions
* Cognitive functioning \> 80 as assessed by the KBIT-II
* Willingness to comply with all study requirements; and
* Ability of child and parent/guardian to communicate verbally and in written form in English.

Inclusion for the ADHD group only:

* Confirmed diagnosis of ADHD, any subtype as determined by the MINI-KID
* Willingness to delay/suspend medication use for the 4-day duration of the study and 2 days prior to the sleep study phase.

Exclusion Criteria:

* History of chronic/significant medical condition
* Use of prescription medications for ADHD during the 2-day washout and/or 4-day study
* Current prescribed use of any other psychotropics, including non-stimulant medications for ADHD
* Current substance abuse or dependence or history within the last 6 months
* Estimated IQ \< 80 as assessed by the KBIT-II
* First degree relative with psychosis or bipolar disorder;
* Parent/Guardian or child unable to communicate verbally and in written form in English; and
* Unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the principal investigator

Exclusion for the ADHD group only:

* Meets criteria for any other Axis I Disorder (determined by the MINI-KID) besides ADHD or Oppositional Defiant Disorder (ODD)

Exclusion for the HEALTHY CONTROL group only:

* Meets criteria for any Axis I Disorder

Primary outcomes:
measure: Objective sleep assessment
timeFrame: 3 consecutive nights
Secondary outcomes:
measure: Neurocognitive assessment
timeFrame: 1 day
measure: Executive functioning as measured by neurocognitive assessment
timeFrame: 1 day
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jessica R Lunsford-Avery, PhD
role: PRINCIPAL_INVESTIGATOR
References: