Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders
Jeanett Friis Rohde1, Elisabeth Ginnerup-Nielsen2, Sofus Christian Larsen2,3
1Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, Frederiksberg, 2000, Denmark. jeanett.friis.rohde@regionh.dk.
Insights
Weighted blankets may improve sleep for children with ADHD. This study compares weighted blankets to sham blankets to assess their effect on total sleep time and daily functioning in children with attention deficit hyperactivity disorder (ADHD).
Area of Science:
- Pediatric Sleep Medicine
- Neurodevelopmental Disorders
- Clinical Trial Research
Background:
- Sleep disturbances are prevalent in children with Attention Deficit Hyperactivity Disorder (ADHD), impacting their overall well-being.
- Weighted blankets are hypothesized to improve sleep by providing sensory input, but empirical evidence is limited.
- This study addresses the sparse data on the efficacy of weighted blankets for ADHD-related sleep issues.
Purpose of the Study:
- To evaluate the effectiveness of weighted blankets in improving total sleep time in children diagnosed with ADHD.
- To compare the impact of weighted blankets versus non-weighted sham blankets on sleep and functional impairments in pediatric ADHD patients.
- To provide evidence for a potential non-pharmacological intervention for sleep problems in children with ADHD.
Main Methods:
- A parallel-group, randomized controlled trial involving 340 children aged 5-12 with ADHD or ADD.
- Participants were randomly assigned to use either a weighted or a non-weighted (sham) blanket nightly for four weeks.
- Primary outcome: change in total sleep time measured by actigraphy; secondary outcomes include functioning, sleep latency, and ADHD symptoms.
Main Results:
- The study is designed to assess changes in total sleep time as the primary outcome.
- Secondary outcomes will investigate effects on child functioning, sleep quality metrics, and ADHD symptom severity.
- Statistical analyses will employ intention-to-treat principles with 95% confidence intervals and p-values.
Conclusions:
- Findings could establish weighted blankets as an evidence-based, non-pharmacological treatment for sleep disturbances in children with ADHD.
- The results may influence clinical practice guidelines and health policies concerning pediatric ADHD management.
- This research has the potential to significantly benefit children with ADHD experiencing sleep difficulties.
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.
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