Weighted Blankets for Sleep Disturbance Among Children With ADHD

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Attention-deficit Hyperactivity, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Sleep Disturbance, Attention Deficit Disorder, Hyperkinetic Conduct Disorder, Attention-Deficit Hyperactivity Disorder, Unspecified Type

In brief

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.

Key facts

Study ID

NCT06194162

Run by

University Hospital Bispebjerg and Frederiksberg

People needed

340

Starts

2024-01-01

Expected to finish

2028-08-01

Last updated by the study team

2024-01-17

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent.
• Age 5-12 years (both included) at randomization.
• Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
• Comorbidities are allowed.
• Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.
• If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.
• The child and caregiver have adequate mastery of the Danish language.

You may not qualify if…

• Have used any type of medical device class 1 weighted blanket before.
• Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).
• Another member of the household enrolled in the trial.

Where it is running

• The Parker Institute, Bispebjerg and Frederiksberg Hospital — Frederiksberg, Denmark (enrolling)

Full record on ClinicalTrials.gov

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