Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH139504 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Many adolescents go to bed late and wake up early for school. Science is only beginning to understand how sleep schedules can affect them. The investigators are interested in whether changing adolescents' sleep patterns affects their functioning, attention, and how they feel. The investigators are especially interested in the effects of changing both how much sleep adolescents get and when that sleep happens.
This study focuses on healthy 13-17-year-olds with ADHD. This study asks adolescents to systematically change their sleeping habits across a 3 week span. The first week, they follow a sleep schedule that fits reasonably well with the schedule they keep when they do not have to wake up early for any specific obligation (e.g., for school). The second week, they spend several nights in a "short sleep" condition, during which they get 6.5 hours in bed per night. The final week, they enter a sleep condition that allows for healthy sleep duration, but with a timing that is randomly assigned to either fit well with their preferred schedule or fit poorly with that schedule. During each week, they and their parents complete measures of their attention and other factors. At the end of each week, they attend an evening session to measure their internal body clock ("circadian phase"), as well as measures of attention and other thinking skills. The goal is to understand whether the benefits of healthy sleep duration depend on the timing of when that sleep occurs.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aligned Sleep Extension | Experimental | One of two variants on the timing of period of when there is an opportunity to get healthy/recommended sleep duration. Aligned sleep extension allows 9.5 hours/night in bed in a manner that broadly fits with an adolescent's chronotype (e.g., early-to-bed and early-to-rise schedule for a morning lark). |
|
| Misaligned Sleep Extension | Experimental | One of two variants on the timing of period of when there is an opportunity to get healthy/recommended sleep duration. Aligned sleep extension allows 9.5 hours/night in bed in a manner that is broadly a poor fit with an adolescent's chronotype (e.g., early-to-bed and early-to-rise schedule for a night owl). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aligned sleep extension | Behavioral | Timing of extended sleep condition is randomly assigned to fit with participant's chronotype |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver- and Adolescent-Reported Symptoms of Inattention | Daily diary listing symptoms of inattention adapted from the IOWA Conners Questionnaire. Adolescents will self-report their own symptoms for the previous day. Parents/caregivers will report on their observations of the adolescents' symptoms for the previous day. Higher scores indicate greater inattention. | Daily throughout each participant's involvement in the study, up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver- and Adolescent-Reported Internalizing Symptoms (depression, anxiety) | Retrospective report of internalizing symptoms based on the Vanderbilt questionnaire across 5 days the previous week. Adolescents will self-report their own symptoms. Parents/caregivers will report on their observations of the adolescents' symptoms. Higher scores indicate greater internalizing symptoms. | Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Non-traditional school setting (morning-afternoon Monday-Friday).
Exclusionary diagnoses. We will exclude adolescents with known intellectual disability, autism spectrum disorder, psychosis, bipolar disorder, or neurologic conditions (e.g., epilepsy), per caregiver-report.
Exclusionary sleep disorders. We will exclude adolescents with symptoms of obstructive sleep apnea or periodic limb movement disorder based on published cutoffs on a validated questionnaire.
High caffeine intake. To promote adherence to directives not to consume caffeine the day of office visits without withdrawal effects, adolescents with daily intake of >1 coffee or "energy drink" or >2 caffeinated sodas per day based on caregiver- and adolescent-report will be excluded.
Refusal to refrain from automobile driving during the sleep restriction condition.
"Intermediate" Chronotypes (neither morning larks nor night owls) based on habitual sleep timing on nights when adolescent has no morning obligations such as school or work.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dean Beebe, Ph.D | Contact | 513-636-3489 | dean.beebe@cchmc.org | |
| Stephen Becker, Ph.D. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Dean Beebe, Ph.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Stephen Becker, Ph.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
Per sponsor policy, primary outcome data will be shared with the NIMH Data Archive (NDA).
Not provided
Per NDA guidelines, data will be uploaded every 6 months throughout the study. Longevity of those data will be determined by the NIMH.
To access study data within NDA, users must submit at Data Request Checklist to NDA, sign the NIMH NDA Data Use Agreement, and submit proof of IRB approval. The Data Request Checklist will specify that data must be used for research purposes only, data will not be shared or sold, attempts will not be made to identify individual participants, etc. The NDA Data Access Committee will decide which requests to grant based on the information submitted. If given access, data access will be granted for one year but this is renewable. Should individuals or organizations request the dataset directly from the investigators, those requests will be directed to the NDA to retrieve the data.
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Misaligned sleep extension | Behavioral | Timing of extended sleep condition is randomly assigned to fit poorly with participant's chronotype |
|
| Caregiver- and Adolescent-Reported Emotional Dysregulation | Retrospective report of symptoms of Emotion Dysregulation (e.g., emotional responses stronger than is called for by a situation) across 5 days the previous week. Previously validated by the investigators against established measures of long-term emotion regulation, this form focuses on a shorter (5-day) period. Adolescents will self-report their own symptoms. Parents/caregivers will report on their observations of the adolescents' symptoms. Higher scores indicate greater dysregulation. | Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits. |
| Caregiver- and Adolescent-Reported Impulsivity | Retrospective report of internalizing symptoms based on the Vanderbilt questionnaire across 5 days the previous week. Adolescents will self-report their own symptoms. Parents/caregivers will report on their observations of the adolescents' symptoms. Higher scores indicate greater internalizing symptoms. | Each office visit during the participant's involvement. Office visits are spaced 1 week apart, for up to three visits. |
| Sleep Period Duration | Nightly sleep period, defined as the simple difference between sleep onset and offset, based on a wrist-mounted accelerometer (wristwatch). | Nightly throughout study participation (around 3 weeks) |
| Inattention | Adolescent-reported attention will me assessed via Ecological Momentary Assessment (EMA) | Twice daily during weeks 2 and 3 of study participation. |
| Inattention, as objectively measured via the NASA PVT+ application (aka Psychomotor Vigilance Test). | Remote-proctored administration via the NASA PVT+, loaded onto an iPhone. This is a computerized measure of sustained attention. Participants must attend to infrequent stimuli on screen as quickly as possible. Higher scores indicate slower or missed responses, and therefore greater inattention. | Four remote administrations: (1) the morning of a predetermined date during Week 2 of study participation; (2) the afternoon of that same Week 2 date; (3) the morning of a predetermined date during Week 3; (4) the afternoon of that same Week 3 date. |