Weighted Blankets for Sleep Disturbance Among Children With ADHD

NCT ID
NCT06194162
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University Hospital Bispebjerg and Frederiksberg
Conditions
Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, Attention-deficit Hyperactivity, Attention-Deficit Hyperactivity Disorder, Unspecified Type, Hyperkinetic Conduct Disorder, Neurodevelopmental Disorders, Sleep Disturbance

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial

Enrollment: 340 participants (Estimated).

What is being studied

  • Device: Non-weighted blanket
  • Device: Weighted blanket

Who may be eligible

Ages
5 Years to 12 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Denmark

Sample of listed locations

  • The Parker Institute, Bispebjerg and Frederiksberg Hospital — Frederiksberg, 2000, Denmark — Recruiting

Study details

Start date
January 1, 2024
Primary completion date
March 31, 2027
Completion date
December 31, 2028
First posted
January 8, 2024
Collaborators
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06194162
Registry last updated
August 14, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06194162 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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