Acquired Brain InjuryWEBLYNCT04860973
Weighted Blankets After Brain Injury
A study testing Weighted blankets in people with Acquired Brain Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Weighted blankets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Feb 2021to 16 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, DE22 3NE
About this study
Official title: A Feasibility Study of Weighted Blankets to Help Agitation and Disturbed Sleep After Brain Injury
A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.
Read the detailed description
A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.
12 subjects will be randomised 1:1 to intervention or control; they will use the allocated linen for 7 consecutive days and nights. Sleep will be measured using observations and actigraphs; behaviour and behavioural interventions will be recorded.
Participants (where possible) and staff members will be interviewed about their experience and opinions.
- Conditions
- Acquired Brain Injury
- Being tested
- Weighted blankets
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted blanketsDevice
Weighted blankets given to patient for 7 days/nights
| Study group | Role | What they receive |
|---|---|---|
| Weighted blankets | Experimental | Provided with weighted blanket suitable for participant's weight Receives: Device: Weighted blankets |
| Standard linen | No intervention | Use of standard hospital linen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Proportion of eligible candidates recruited within the time frame
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start11 Feb 2021
- Primary completion16 May 2023
- Study completion16 May 2023
Why it stopped: Of those randomised to intervention arm, the majority were not able to tolerate the intervention for the duration of the study indicating that it is not feasible on a larger scale and recruiting 2 extra participants would not change this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860973
- Sponsor's protocol ID
- UHDB/2020/024
- Acronym
- WEBLY
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Weighted Blankets to Help Agitation and Disturbed Sleep After Brain Injury
- ClinicalTrials.gov ID
- NCT04860973
- Acronym / sponsor ID
- WEBLY / UHDB/2020/024
- Conditions
- Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Of those randomised to intervention arm, the majority were not able to tolerate the intervention for the duration of the study indicating that it is not feasible on a larger scale and recruiting 2 extra participants would not change this decision.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.
Detailed description
A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.
12 subjects will be randomised 1:1 to intervention or control; they will use the allocated linen for 7 consecutive days and nights. Sleep will be measured using observations and actigraphs; behaviour and behavioural interventions will be recorded.
Participants (where possible) and staff members will be interviewed about their experience and opinions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted blankets | Experimental | Device: Weighted blanketsProvided with weighted blanket suitable for participant's weight |
| Standard linen | No intervention | –Use of standard hospital linen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted blanketsWeighted blankets given to patient for 7 days/nights | Device | Weighted blankets |
Primary outcome
Recruitment
Time frame: 12 months
Proportion of eligible candidates recruited within the time frame
Results and safety
The study was stopped early (reason given: Of those randomised to intervention arm, the majority were not able to tolerate the intervention for the duration of the study indicating that it is not feasible on a larger scale and recruiting 2 extra participants would not change this decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Acquired Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
RecruitingObservational study
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
Small Cell Lung Cancer ( SCLC ), Brain Injury
Not yet recruitingObservational study
Description of Clinicians' Predictive Abilities Before and After a Diffusion Tensor Imaging (DTI)
Diffusion Tensor Imaging Prognosis, Brain Injury, Traumatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted blankets in people with Acquired Brain Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Of those randomised to intervention arm, the majority were not able to tolerate the intervention for the duration of the study indicating that it is not feasible on a larger scale and recruiting 2 extra participants would not change this decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.