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Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD

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ClinicalTrials.gov Identifier: NCT02732756
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Healthy Sleep Duration Behavioral: Shortened Sleep Duration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD
Actual Study Start Date : April 21, 2016
Actual Primary Completion Date : August 25, 2017
Actual Study Completion Date : August 25, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sleep Restriction
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.
 Behavioral: Shortened Sleep Duration
This study examines shortened sleep duration as related to poorer functioning in adolescents with ADHD. Adolescent participants will be instructed to go to bed at a time such that they are in bed for 6.5 hours per night. Researchers will work with the adolescent and their family to problem-solve how to accomplish this sleep duration goal.
Experimental: Sleep Extension
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.
 Behavioral: Healthy Sleep Duration
This study examines healthy sleep duration as related to improved functioning in adolescents with ADHD. Adolescent participants will be instructed to go to bed at a time such that they are able to obtain 9 hours of nightly sleep (9.5 hours in bed, leaving up to ½ hour to fall asleep). Researchers will work with the adolescent and their family to problem-solve how to accomplish this sleep duration goal.


Outcome Measures
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Primary Outcome Measures :
  1. Change in sleep duration [ Time Frame: 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 :
  1. Change in ADHD symptoms [ Time Frame: 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.

  2. Change in internalizing symptoms [ Time Frame: 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.

  3. Change in behavioral functioning [ Time Frame: 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.

  4. Change in cognitive functioning [ Time Frame: 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.

  5. Change in emotion regulation [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732756


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Mental Health (NIMH)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02732756    
Other Study ID Numbers: CIN_ADHDsleep_001
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
ADHD
Sleep
Attention
Adolescence
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Oxymetazoline
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents