Weighted Blankets for Sleep Disturbance Among Children With ADHD

Launched by UNIVERSITY HOSPITAL BISPEBJERG AND FREDERIKSBERG · Dec 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether using weighted blankets can help improve sleep for children aged 5 to 12 who have Attention-Deficit Hyperactivity Disorder (ADHD). Many children with ADHD have trouble sleeping, which can affect their growth and well-being. The trial aims to see if a weighted blanket, which provides gentle pressure and can help calm children, makes a difference in their sleep compared to a regular blanket. Participants will be randomly assigned to either use a weighted blanket or a regular blanket while continuing their usual treatment. The main goal is to see if there are any changes in how long the children sleep.

To be eligible for the trial, children must be between 5 and 12 years old, have a diagnosis of ADHD, and have tried other sleep programs without success in the last six months. They should also be stable on any ADHD or sleep medications for at least two weeks before joining. This trial is open to all genders, and it will help doctors and professionals understand whether weighted blankets can be a helpful tool for children struggling with sleep issues. Participants and their families can expect to be part of a study that could potentially lead to better sleep solutions for children with ADHD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent.
• • 2. Age 5-12 years (both included) at randomization.
• • 3. Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
• • 4. Comorbidities are allowed.
• • 5. Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.
• • 6. If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.
• • 7. The child and caregiver have adequate mastery of the Danish language.
• Exclusion Criteria:
• • 1. Have used any type of medical device class 1 weighted blanket before.
• • 2. 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).
• • 3. Another member of the household enrolled in the trial.