Using weighted blankets to improve sleep in children with ADHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.