Weighted Blankets After Brain Injury (WEBLY)

March 2, 2026 updated by: University Hospitals of Derby and Burton NHS Foundation Trust

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Derby, United Kingdom, DE22 3NE
        • University Hospitals of Derby & Burton NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weighted blankets
Provided with weighted blanket suitable for participant's weight
Device: Weighted blankets
Weighted blankets given to patient for 7 days/nights
No Intervention: Standard linen
Use of standard hospital linen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: 12 months
Proportion of eligible candidates recruited within the time frame
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2021

Primary Completion (Actual)

May 16, 2023

Study Completion (Actual)

May 16, 2023

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHDB/2020/024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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