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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Attention Deficit Hyperactivity Disorder

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).


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Neurocognitive assessment [ Time Frame: 1 day ]
    Computerized measure of neurocognition.

  2. Executive functioning as measured by neurocognitive assessment [ Time Frame: 1 day ]
    Measure of executive function



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescents with ADHD and healthy control adolescents
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

Information from the National Library of Medicine

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


Contacts
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Contact: Leah Akins, MSc 919-681-0013 leah.l.akins@duke.edu

Locations
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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    jessica.r.avery@duke.edu   
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jessica R Lunsford-Avery, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02897362     History of Changes
Other Study ID Numbers: Pro00072033
1K23MH108704-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
ADHD
Sleep
Adolescents
Neurocognition
Polysomnography

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders