NCT04860973

Weighted Blankets After Brain Injury

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Acquired Brain Injury

Interventions

Type	Name	Description
DEVICE	Weighted blankets	Weighted blankets given to patient for 7 days/nights

Timeline

• Start date: 2021-02-11
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2021-04-27
• Last updated: 2026-03-04

Locations

1 site across 1 country: United Kingdom