Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: Shortened Sleep Duration; Behavioral: Healthy Sleep Duration

• Registration Number: NCT02732756
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Adolescents with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their typically developing peers. Observational studies indicate that inadequate sleep is correlated with impairment in adolescents with ADHD, but it remains unknown if sleep is causally related to impairment. This study will use an experimental sleep restriction and extension protocol to evaluate sleep as a contributor to clinically significant impairment and possible target for intervention in adolescents with ADHD.

Detailed Description

Teens with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their peers, with up to 75% of youth with ADHD obtaining insufficient sleep. This is noteworthy since insufficient sleep is associated with a multitude of negative outcomes in typically developing teens, including academic underachievement, emotion dysregulation, and mental health problems - all outcomes that occur at higher rates among teens with ADHD. Our pilot work demonstrates that insufficient sleep is correlated with depression, behavior problems, and academic impairment in teens with ADHD specifically and insufficient sleep is clearly associated with greater attentional problems in typical teens. However, no experimental study has examined whether sleep duration is causally linked to attentional, behavioral, emotional, and academic impairments in teens diagnosed with ADHD. If sleep problems contribute to functional impairments in teens with ADHD, then they represent an overlooked treatment target. Experimental studies provide the strongest test of causality, and studies using at-home sleep restriction protocols in teens without ADHD show a causal link between shortened sleep duration and impairment. However, administering an at-home sleep restriction protocol may be especially challenging for teens with ADHD due to their difficulties with organizing bedtime and wake activities, as well as differences from healthy teens in biological circadian preference. Thus, a critical first step in examining sleep as causally related to impairment in teens with ADHD is documenting the feasibility of using an at-home sleep restriction protocol with this population. This study will (1) evaluate the feasibility of using an at-home sleep restriction protocol in teens with ADHD, and (2) collect preliminary data examining whether shortened sleep duration is causally linked to attentional, behavioral, emotional, and academic impairment in teens with ADHD. These goals will be accomplished by recruiting 54 teens with ADHD who will undergo a three-week sleep manipulation protocol. Specifically, a cross-over design will be used that includes a week of typical sleep followed by weeks of sleep restriction or sleep extension. Sleep functioning will be assessed during these three weeks with daily sleep diary and objective sleep measurement (i.e., actigraphy). After each sleep condition, teens and their parents will complete subjective and objective measures of attention, behavior, mood, and academics. Findings from this study will allow us to identify and address barriers to administering an at-home sleep restriction and extension protocol to teens with ADHD and pursue larger-scale experimental research examining sleep problems as causally linked to impairment. This research is clinically significant since teens with ADHD frequently experience a range of impairments that extend well into adulthood. If short sleep duration contributes to functional impairments in teens with ADHD, then sleep represents a modifiable and overlooked treatment target.

Study Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-11
• Study Start: 2016-04-21
• Primary Completion: 2017-08-25
• Study Completion: 2017-08-25
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Between 14 and 17 years of age.
• Estimated IQ ≥ 70.
• Meet full DSM-5 criteria for ADHD.
• Sufficient English language ability necessary to complete study measures.
• If applicable, the family must be willing to discontinue any treatment with a psychostimulant medication during the three-week sleep manipulation protocol.

Exclusion Criteria

• Children with an autism spectrum disorder or diagnosed with psychosis, bipolar disorder, or obsessive-compulsive disorder based on the K-SADS diagnostic interview will be excluded.
• Children taking any psychiatric medication that is not a psychostimulant.
• Significant visual, hearing, or speech impairment.
• Organic brain injury or history of seizures.
• Symptoms of obstructive sleep apnea (OSA), periodic limb movement disorder (PLMD), or delayed sleep phase syndrome (DSPS).
• Obligations that require bedtime later than 10pm or waking prior to 5:30am any morning of the study.
• Daily consumption of >1 coffee or "energy drink" or >3 caffeinated sodas.
• Highly atypical sleep, defined as <6 hours or >9.5 hours on school nights per parent and adolescent report.
• Inability or refusal to refrain from automobile driving or other high-risk tasks that require vigilance during the sleep restriction week of the study.
• Finally, at the visit following the baseline week (week 1) of the sleep protocol, we will exclude teens whose actigraphs reflect an inability to consistently arise within 1 hour of the agreed-upon time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sleep Restriction	Shortened Sleep Duration	The Sleep Restriction condition will allow 6.5 hours in bed, which in previous research results in an average of 6.1-6.3 hours of nightly sleep. This condition reflects a realistic dose of sleep restriction (similar to the school-night sleep of 15-20% of healthy adolescents) that has been shown to be feasible and to induce daytime sleepiness, inattention, and irritability/moodiness in typically developing adolescents.
Sleep Extension	Healthy Sleep Duration	The Sleep Extension condition will allow adolescents to obtain 9 hours of nightly sleep (9.5 hours in bed, leaving up to ½ hour to fall asleep), which (a) is how long adolescents sleep during controlled trials of sleep satiation and naturally on non-school nights, (b) has been shown to result in a well-rested state, and (c) matches clinical recommendations for adolescents.

Primary Outcome Measures

Name	Time	Method
Change in sleep duration	Following each of the two arms that each last one week.	Sleep duration will be assessed with actigraphy for five days during each sleep restriction/extension experimental arm. The sleep duration outcome will be assessed as the change in average nightly sleep duration between the sleep restriction and sleep extension arms.

Secondary Outcome Measures

Name	Time	Method
Change in behavioral functioning	Following each of the two arms that each last one week.	Oppositional symptoms will be assessed using parent ratings at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The oppositional behavior outcome will be assessed as the change in oppositional behaviors between the two week-long experimental arms.
Change in cognitive functioning	Following each of the two arms that each last one week.	Cognitive functioning will be assessed using neuropsychological test performance at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The outcome will be assessed as the change in neuropsychological test performance between the two week-long experimental arms.
Change in ADHD symptoms	Following each of the two arms that each last one week.	ADHD symptoms will be assessed using parent and adolescent ratings at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The ADHD symptom outcome will be assessed as the change in ADHD symptoms between the two week-long experimental arms.
Change in internalizing symptoms	Following each of the two arms that each last one week.	Internalizing symptoms will be assessed using parent and adolescent ratings at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The internalizing outcome will be assessed as the change in internalizing symptoms between the two week-long experimental arms.
Change in emotion regulation	Following each of the two arms that each last one week.	Emotion regulation will be assessed using parent and adolescent ratings at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The emotion regulation outcome will be assessed as the change in emotion regulation between the two week-long experimental arms.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States