BridgeMD
New treatment option for Attention-deficit Hyperactivity
Official title Weighted Blankets for Sleep Disturbance Among Children With ADHD
ClinicalTrials.gov ID: NCT06194162
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 12
You may be able to join if
- Signed informed consent.
- Age 5-12 years (both included) at randomization.
- Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
- Comorbidities are allowed.
- Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.
You likely can't join if
- Have used any type of medical device class 1 weighted blanket before.
- Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe...
- Another member of the household enrolled in the trial.
See the full eligibility criteria
- Signed informed consent.
- Age 5-12 years (both included) at randomization.
- Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
- Comorbidities are allowed.
- Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.
- If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.
- The child and caregiver have adequate mastery of the Danish language.
- Have used any type of medical device class 1 weighted blanket before.
- 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...
- Another member of the household enrolled in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Frederiksberg, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frederiksberg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.