Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial
Abstract
Introduction: Sleep disturbances are common among children with attention deficit hyperactivity disorder (ADHD) and may affect well-being. Weighted blankets have been proposed to reduce restlessness via sensory integration by stimulating the tactile and proprioceptive senses. Evidence for an effect on sleep and functional impairment is however sparse. We here describe a trial which aims to compare the effect of using a weighted blanket relative to a non-weighted sham blanket on total sleep time in children with ADHD.
Methods: A parallel group randomised controlled trial will be conducted. We anticipate enrolling 340 patients from six public and one private child and adolescent mental health centres in the Capital Region of Denmark. Patients are aged 5 to 12 years, diagnosed with ADHD or attention deficit disorders (ADD) according. Patients will be randomly allocated (1:1) to either a weighted or non-weighted blanket as add-on to usual treatment. The allocation sequence will be stratified by age (5-8 years vs. 9-12 years), ADHD medication (yes vs. no) and use of sleep medication (yes vs. no). Patients in both groups will be guided in using the weighted- or non-weighted blanket every night and at least once daily for four weeks. The primary outcome will be change from baseline to end of trial 4 weeks from baseline in average total night sleep time, assessed with sleep actigraphy. Secondary outcomes are child functioning impairment, sleep onset latency, number of awakenings,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 340 participants or records.
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