NCT06194162 Weighted Blankets for Sleep Disturbance Among Children With ADHD
| NCT ID | NCT06194162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Bispebjerg and Frederiksberg |
| Condition | Attention-deficit Hyperactivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2024-01-01 with a primary completion date of 2026-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.
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.
Contact & Investigator
Ina O. Specht, Ph.d.
PRINCIPAL INVESTIGATOR
Research Unit for Dietary Studies, The Parker Institute
Frequently Asked Questions
Who can join the NCT06194162 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Attention-deficit Hyperactivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06194162 currently recruiting?
Yes, NCT06194162 is actively recruiting participants. Contact the research team at ina.olmer.specht@regionh.dk for enrollment information.
Where is the NCT06194162 trial being conducted?
This trial is being conducted at Frederiksberg, Denmark.
Who is sponsoring the NCT06194162 clinical trial?
NCT06194162 is sponsored by University Hospital Bispebjerg and Frederiksberg. The principal investigator is Ina O. Specht, Ph.d. at Research Unit for Dietary Studies, The Parker Institute. The trial plans to enroll 340 participants.