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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, United Kingdom
Start Date
February 11, 2021
Primary Completion Date
May 16, 2023
Completion Date
May 16, 2023
Last Updated
March 4, 2026
10
ACTUAL participants
Weighted blankets
DEVICE
Lead Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
NCT07378592
NCT06774287
NCT07119827
Data Source & Attribution
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