Status:
RECRUITING
Weighted Blankets for Sleep Disturbance Among Children With ADHD
Lead Sponsor:
University Hospital Bispebjerg and Frederiksberg
Collaborating Sponsors:
Mental Health Services in the Capital Region, Denmark
Conditions:
Attention-deficit Hyperactivity
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief 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 difficult...
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, affecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06194162
Start Date
January 1 2024
End Date
August 1 2028
Last Update
January 17 2024
Active Locations (1)
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1
The Parker Institute, Bispebjerg and Frederiksberg Hospital
Frederiksberg, Denmark, 2000