ArticleBMC psychiatry2025
Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial.
Article in BMC psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06194162 (Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSleep 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.
methodsA 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 registrationThe study protocol is registered on ClinicalTrials.gov no. NCT06194162. Registered on January 8, 2024. PROTOCOL VERSION: Version 1.0.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.