NCT06194162

Weighted Blankets for Sleep Disturbance Among Children With ADHD

Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.

Detailed description

Over the past decade, interest in the relationship between sleep difficulties and ADHD has increased, with evidence showing that sleep problems are very common among school children with ADHD, affecting nearly three-quarters. Sleep problems may worsening daytime behaviors and may also affect the overall wellbeing of the family, leading to poorer parental mental health and higher stress. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. The study is designed as a superiority trial: a parallel group, randomised controlled trial, where participants are randomised to one of two study arms 1:1. The sample consists of 340 participants, divided into two groups. After randomisation each participant will stay in their assigned treatment arm during the entire study. For each study participant, the active intervention period is 28 days with assessment of primary and secondary outcomes at baseline and after 28 days of intervention. Thereafter participants will be followed through national health registers. The trial will take place at the Child and Adolescent Mental Health Center, Mental Health Services in the Capital Region of Denmark. This center is providing assessment and treatment of children and adolescents with psychiatric disorders.

Conditions

• Attention-deficit Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Neurodevelopmental Disorders
• Sleep Disturbance
• Attention Deficit Disorder
• Hyperkinetic Conduct Disorder
• Attention-Deficit Hyperactivity Disorder, Unspecified Type

Interventions

Type	Name	Description
DEVICE	Weighted blanket	The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment. Participants will be asked to choose one out of at least three different weighted blankets, each with different weight classes. The choice of weighted blanket is solely taken by the participant after having tried all five blankets. Adherence to the weighted blanket intervention is defined as reported use 60 % of the intervention period. Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication.
DEVICE	Non-weighted blanket	The control comparator will receive a sham intervention in the form of a non-weighted blanket as an add on to usual care. Participants will be asked to choose one out of two different sham blankets. Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-04-15
• Completion: 2028-08-01
• First posted: 2024-01-08
• Last updated: 2024-01-17

Locations

1 site across 1 country: Denmark