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NCT04860973 Clinical Trial

Weighted Blankets After Brain Injury

Acquired Brain Injury Clinical Trial

— WEBLY  

Official title:
A Feasibility Study of Weighted Blankets to Help Agitation and Disturbed Sleep After Brain Injury

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04860973
Other study ID # UHDB/2020/024
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 11, 2021
Est. completion date May 16, 2023

Study information
Verified date August 2023
Source University Hospitals of Derby and Burton NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date May 16, 2023
Est. primary completion date May 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Weighted blankets
Weighted blankets given to patient for 7 days/nights

Locations
Country Name City State
United Kingdom University Hospitals of Derby & Burton NHS Foundation Trust Derby

Sponsors (1)
Lead Sponsor Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recruitment Proportion of eligible candidates recruited within the time frame 12 months
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