Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD

NCT02897362 | Completed

• 2 other identifiers: Pro000720331K23MH108704-01A1
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Sleep; Adolescents; Neurocognition; Polysomnography

Outcome Measures

Primary Outcomes (1)

• Objective sleep assessment

  Ambulatory polysomnographic measures of total sleep time, sleep onset latency, wake after sleep onset, and EEG spectral dynamics.

  3 consecutive nights

Secondary Outcomes (2)

• Neurocognitive assessment

  1 day

• Executive functioning as measured by neurocognitive assessment

  1 day

Study Arms (2)

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.

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with ADHD and healthy control adolescents

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Lunsford-Avery JR, Carskadon MA, Kollins SH, Krystal AD. Sleep Physiology and Neurocognition Among Adolescents With Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2025 Feb;64(2):276-289. doi: 10.1016/j.jaac.2024.03.005. Epub 2024 Mar 12.

  PMID: 38484795 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jessica R Lunsford-Avery, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 13, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)