Using weighted blankets to improve sleep in children with ADHD
Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial
This study is testing whether using weighted blankets can help children with ADHD, ages 5 to 12, sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 1 site (Frederiksberg) |
| Trial ID | NCT06194162 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of weighted blankets on sleep disturbances in children aged 5-12 years diagnosed with ADHD. It employs a randomized controlled trial design, where participants are assigned to either receive a weighted blanket or a non-weighted sham blanket in addition to their usual treatment. The primary outcome measured will be the differences in total sleep time between the two groups. The study aims to provide evidence on the efficacy of weighted blankets in improving sleep quality for children with ADHD, addressing a significant issue that affects their overall well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-12 years with a primary diagnosis of ADHD who have not responded to standard sleep hygiene interventions.
Not a fit: Patients who have previously used weighted blankets or have significant comorbid conditions that affect adherence to the intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological intervention to improve sleep quality in children with ADHD.
How similar studies have performed: While only one previous randomized controlled trial has investigated the effects of weighted blankets in children with ADHD, this study aims to expand on that limited evidence base.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Frederiksberg
- The Parker Institute, Bispebjerg and Frederiksberg Hospital — Frederiksberg, Denmark (Recruiting)
Study contacts
- Principal investigator: Ina O. Specht, Ph.d. — Research Unit for Dietary Studies, The Parker Institute
- Study coordinator: Ina O. Specht, Ph.d.
- Email: ina.olmer.specht@regionh.dk
- Phone: +45 51197904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.