Weighted Blankets for Sleep Disturbance Among Children With ADHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Weighted blanket, Non-weighted blanket.
- Who it may be relevant to
- Registry conditions: Attention-deficit Hyperactivity, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Sleep Disturbance. Basic parameters: 5 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial
Overview
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.
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 stand - 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.
Primary outcome measures
- Changes in total sleep time (average minutes per day) [Time frame: Week 0 and 4]
Secondary outcome measures (9)
- Changes in functional impairment [Time frame: Week 0 and 4]
- Changes in sleep onset latency (average minutes per day) [Time frame: Week 0 and 4]
- Changes in number of awakenings (numbers per night) [Time frame: Week 0 and 4]
- Changes in sleep efficiency (percentage) [Time frame: Week 0 and 4]
- Changes in ADHD core symptoms (score point) [Time frame: Week 0 and 4]
- Changes in parental stress (score point) [Time frame: Week 0 and 4]
- Changes in child quality of life (score point) [Time frame: Week 0 and 4]
- Adverse events (Number of participants with adverse events) [Time frame: During intervention]
- Serious adverse events (Number of participants with serious adverse events) [Time frame: During intervention]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- The Parker Institute, Bispebjerg and Frederiksberg Hospital — Frederiksberg
Publications
- Rohde JF, Ginnerup-Nielsen E, Larsen SC, Tjott C, Christensen R, Heitmann BL, Waehrens EE, Pagsberg AK, Specht IO. Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial. BMC Psychiatry. 2025 Apr 8;25(1):345. doi: 10.1186/s12888-025-06768-6. PMID 40200167
Identifiers
NCT: NCT06194162 · Sweet Dreams