Weighted Blankets After Brain Injury | NCT04860973

Studies
Weighted Blankets After Brain Injury

NCT04860973

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Status

Terminated

Last Update Posted

Mar 4, 2026Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Acquired Brain Injury

Interventions

Weighted blankets

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why 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.

Expanded Access Info

Start Date

Feb 11, 2021Actual

Primary Completion Date

May 16, 2023Actual

Completion Date

May 16, 2023Actual

First Submitted Date

Sep 8, 2020

First Submission Date that Met QC Criteria

Apr 22, 2021

First Posted Date

Apr 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2026

Last Update Posted Date

Mar 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Weighted blankets	Experimental	Provided with weighted blanket suitable for participant's weight	Device: Weighted blankets
Standard linen	No Intervention	Use of standard hospital linen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weighted blankets	Device	Weighted blankets given to patient for 7 days/nights	Weighted blankets

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Derby & Burton NHS Foundation Trust		Derby		DE22 3NE	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided