Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial.

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, sleep efficiency, ADHD core symptoms, quality of life, and parental quality of life and stress. Main analyses for the efficacy outcomes will be assessed using intention-to-treat analysis. All results from statistical analyses on key secondary endpoints will be accompanied by two-sided 95% CIs and corresponding p values.

DISCUSSION

The implication of this trial holds the potential to have substantial impact on clinical practices and health policy. The research findings could establish an evidence-based, non-pharmacological approach for children with ADHD and sleep problems.

TRIAL REGISTRATION

The study protocol is registered on ClinicalTrials.gov no. NCT06194162. Registered on January 8, 2024.

PROTOCOL VERSION

Version 1.0.