Actively Recruiting
Weighted Blankets for Sleep Disturbance Among Children With ADHD
Led by University Hospital Bispebjerg and Frederiksberg · Updated on 2024-01-17
340
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
U
University Hospital Bispebjerg and Frederiksberg
Lead Sponsor
M
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Weighted Blankets for Sleep Disturbance Among Children With ADHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 5-12 years at randomization
- Primary diagnosis of ADHD according to ICD-10 codes F90.0, F90.1, F90.9, or F98.8
- Comorbidities are allowed
- Participated in a usual care sleep hygiene program without effect within 6 months prior to enrollment
- Stable dose of ADHD medication and/or melatonin/sleep medication for at least two weeks prior to enrollment
- Child and caregiver have adequate mastery of the Danish language
You will not qualify if you...
- Prior use of any class 1 medical device weighted blanket
- Diagnosed diseases that significantly impair ability to adhere to intervention, such as mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, or osteoporosis
- Another member of the household enrolled in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Parker Institute, Bispebjerg and Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Actively Recruiting
Research Team
I
Ina O. Specht, Ph.d.
CONTACT
J
Jeanett F. Rohde, Ph.d.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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