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Do weighted blankets unlock better sleep for kids with ADHD?

NCT ID NCT06194162

Symptom relief Sponsor: University Hospital Bispebjerg and Frederiksberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests whether using a weighted blanket at night and during the day can improve sleep in children aged 5-12 with ADHD who still have sleep problems despite standard care. Half the children will receive a weighted blanket, while the other half gets a non-weighted sham blanket, and both groups continue their usual treatment. The main goal is to see if the weighted blanket increases total sleep time, which could offer a simple, non-drug option to help these children rest better and improve their well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Weighted blanket (a medical device class 1) used during night and daytime, in addition to usual treatment
What this could lead to
If effective, weighted blankets could become a simple, drug-free way to help children with ADHD sleep better and improve their daily functioning.
What could go wrong
This is a relatively early trial, and the only prior study on this topic was small. The effect may be modest, and some children might not find the blanket comfortable or adhere to using it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder conduct disorder neurodevelopmental disorder Parasomnias sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Attention deficit disorder Attention deficit hyperactivity disorder Attention-deficit hyperactivity Attention-deficit hyperactivity disorder, unspecified type Hyperkinetic conduct disorder Neurodevelopmental disorders Sleep disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Parker Institute, Bispebjerg and Frederiksberg Hospital

    RECRUITING

    Frederiksberg, 2000, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.