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Weighted blankets may soothe agitation after brain injury

NCT ID NCT04860973

Symptom relief Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether weighted blankets can help reduce agitation and improve sleep in people recovering from a brain injury. Ten adults in a UK rehabilitation unit used the blankets for 7 days. The main goal was to see if such a study is practical in a hospital setting, not to prove the blankets work.

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 (device)
What this could lead to
If it works, this could point toward a simple, drug-free way to help people with brain injury feel calmer and sleep better.
What could go wrong
This was a very small feasibility study with only 10 participants and it was terminated early, so results are limited. It is not yet proven to be effective.

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

10 people

The number who actually took part.

Started

Feb 2021

Finished

May 2023

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

18 years and older

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 * Subjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving assent on the subject's behalf * Aged over 18 years * Admitted to King's Lodge Neurorehabilitation Unit for inpatient rehabilitation after a brain injury * Within weight limits to be suitable for weighted blanket use Exclusion Criteria * On end of life pathway * Pain which could be exacerbated by weighted blanket * Unable to remove * Presence of open wound / pressure sore * Allergy to blanket material * Participant or consultee unable or unwilling to give informed consent / assent * Known respiratory disorder such as asthma, chronic obstructive pulmonary disease, obstructive sleep apnoea which could be exacerbated by use of heavy blanket over chest * Claustrophobia

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Conditions

The condition(s) this trial relates to.

brain injury

As listed by the trial registrant

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

Acquired brain injury

Contacts and locations

Locations

  • University Hospitals of Derby & Burton NHS Foundation Trust

    Derby, DE22 3NE, United Kingdom

More trials for these conditions

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