Sleep as an outcome measure in ADHD randomized controlled trials: A scoping review.

Sleep disturbances are highly prevalent among children with ADHD. Yet, diagnostic and treatment regimens are primarily focused on daytime symptomatology. The goals of this scoping review are to 1) identify interventional ADHD RCTs that have used sleep as an outcome measure, 2) describe and assess the validity of tools utilized to measure sleep-specific outcomes. 40/71 RCTs used sleep as a primary outcome. Actigraphy (n = 18) and sleep log/diary (n = 16) were the most common tools to measure sleep, followed by Children's Sleep Habits Questionnaire (n = 13), and polysomnography (n = 10). Sleep was a secondary outcome in 31 RCTs. Polysomnography and actigraphy used a heterogeneous spectrum of sleep-related variables and technical algorithms, respectively. 19/23 sleep questionnaires were validated covering a spectrum of sleep-related domains. Despite the intrinsic nature of sleep disturbances in ADHD, the number of RCTs measuring sleep-specific outcomes is limited and tools to measure outcomes are not standardized. Given the potential adverse effects of ADHD medications on sleep, sleep should be included as a core outcome measure in future clinical trials.