Retail-grade weighted blanket for 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 is a single-group, open-label study enrolling 100 children aged 5–12 with ADHD and sleep problems at two Danish hospitals. All participants use a retail-grade weighted blanket for four weeks, and researchers compare each child’s sleep before and after the intervention. Primary questions include changes in total sleep time, time to fall asleep, frequency of nocturnal awakenings, and overall sleep efficiency. The study also looks at whether better sleep relates to daytime functioning, ADHD symptoms, parental stress, and child well-being, while monitoring adverse events. Inclusion requires prior sleep hygiene efforts and stable medication dosing when applicable; contraindications include recent weighted blanket use or conditions that would impair adherence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent.
2. Age 5-12 years.
3. Diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
4. Participated in a usual care sleep hygiene program managed by clinicians within 6 months prior to enrollment.
5. If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.
6. The child and caregiver have adequate mastery of the Danish language.

Exclusion Criteria:

1. Have used any type of weighted blanket within a 3-month period.
2. Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like severe or deep mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).
3. Another member of the household currently or previously enrolled in the Sweet Dreams Trial or the Sweet BEAD trial.

Where it's running

• Bispebjerg and Frederiksberg Hospital, The Parker Institute
  Frederiksberg, Denmark Recruiting

Study contacts

• Study coordinator: Gustav Due Milling, MSc
• Email: gustav.due.milling@regionh.dk
• Phone: +4551197904

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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.