RecruitingNot ApplicableNCT06194162

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

Sponsor

University Hospital Bispebjerg and Frederiksberg

Enrollment

340 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 5 YearsMax Age: 12 Years

Inclusion Criteria7

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.

Exclusion Criteria3

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.

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Interventions

DEVICEWeighted 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.

DEVICENon-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.