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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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04860973
Study type Interventional
Source University Hospitals of Derby and Burton NHS Foundation Trust
Contact
Status Not yet recruiting
Phase N/A
Start date April 2021
Completion date May 2022

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