Weighted Blankets for Sleep Disturbance Among Children With ADHD

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.

NCT Number	NCT06194162
Lead Sponsor	University Hospital Bispebjerg and Frederiksberg Collaborators: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Conditions	Attention-deficit Hyperactivity, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Sleep Disturbance, Attention Deficit Disorder, Hyperkinetic Conduct Disorder, Attention-Deficit Hyperactivity Disorder, Unspecified Type
Enrollment	340 participants
Start Date	2024-01-01
Primary Completion	2027-03-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-14