Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD

NCT ID: NCT02897362

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-07-01

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).

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica R Lunsford-Avery, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Child and Family Study Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38484795 (View on PubMed)

Other Identifiers

1K23MH108704-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00072033

Identifier Type: -

Identifier Source: org_study_id