Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD

NCT02732756 | Completed

• 1 other identifier: CIN_ADHDsleep_001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Sleep; Attention; Adolescence

Outcome Measures

Primary Outcomes (1)

• Change in sleep duration

  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.

  Following each of the two arms that each last one week.

Secondary Outcomes (5)

• 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 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 emotion regulation

  Following each of the two arms that each last one week.

Study Arms (2)

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.

Behavioral: Shortened Sleep Duration

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.

Behavioral: Healthy Sleep Duration

Interventions

Healthy Sleep Duration BEHAVIORAL

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.

Sleep Extension

Shortened Sleep Duration BEHAVIORAL

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.

Sleep Restriction

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Becker SP, Epstein JN, Tamm L, Tilford AA, Tischner CM, Isaacson PA, Simon JO, Beebe DW. Shortened Sleep Duration Causes Sleepiness, Inattention, and Oppositionality in Adolescents With Attention-Deficit/Hyperactivity Disorder: Findings From a Crossover Sleep Restriction/Extension Study. J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):433-442. doi: 10.1016/j.jaac.2018.09.439. Epub 2018 Nov 2.

  PMID: 30768404 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 11, 2016
• Study Start: April 21, 2016
• Primary Completion: August 25, 2017
• Study Completion: August 25, 2017
• Last Updated: October 12, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)