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临床试验/NCT02732756
NCT02732756已完成不适用

Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2016年4月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Change in sleep duration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between 14 and 17 years of age.
  • Estimated IQ ≥
  • 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.

排除标准

  • 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.

研究组 & 干预措施

Sleep Restriction

Experimental

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.

干预措施: Shortened Sleep Duration (Behavioral)

Sleep Extension

Experimental

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.

干预措施: Healthy Sleep Duration (Behavioral)

结局指标

主要结局

Change in sleep duration

时间窗: 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.

次要结局

  • Change in behavioral functioning(Following each of the two arms that each last one week.)
  • Change in cognitive functioning(Following each of the two arms that each last one week.)
  • Change in ADHD symptoms(Following each of the two arms that each last one week.)
  • Change in internalizing symptoms(Following each of the two arms that each last one week.)
  • Change in emotion regulation(Following each of the two arms that each last one week.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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