Attention Deficit Hyperactivity DisorderNCT02897362
Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents with ADHD and healthy control adolescents
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
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.
Read the 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
- Keywords
- ADHD, Sleep, Adolescents, Neurocognition, Polysomnography
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective sleep assessment
Ambulatory polysomnographic measures of total sleep time, sleep onset latency, wake after sleep onset, and EEG spectral dynamics.
Measured: 3 consecutive nights
Secondary outcomes (2)
Neurocognitive assessment
Computerized measure of neurocognition.
Measured: 1 day
Executive functioning as measured by neurocognitive assessment
Measure of executive function
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jessica R Lunsford-Avery, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897362
- Sponsor's protocol ID
- Pro00072033
- Other IDs
- 1K23MH108704-01A1
- Status last verified
- Apr 2021
- First submitted
- 2 Sep 2016
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 38484795
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD
- ClinicalTrials.gov ID
- NCT02897362
- Acronym / sponsor ID
- Pro00072033
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Sleep, Adolescents, Neurocognition, Polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2016
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents with ADHD and healthy control adolescents
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Neurocognitive assessment
Time frame: 1 day
Executive functioning as measured by neurocognitive assessment
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Derived from this study: PubMed 38484795Lunsford-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.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica R Lunsford-Avery, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective sleep assessment (time frame: 3 consecutive nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02897362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.