Weighted Blankets for Sleep Disturbance Among Children With ADHD

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.

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

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.

Sponsors & Collaborators

• Mental Health Services in the Capital Region, Denmark

  collaborator OTHER

• University Hospital Bispebjerg and Frederiksberg

  lead OTHER

Principal Investigators

• Ina O. Specht, Ph.d. · Research Unit for Dietary Studies, The Parker Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2026-04-15

Completion

2028-08-01

Countries

• Denmark

Study Locations