Weighted Blankets After Brain Injury

Not Applicable

Terminated

• Conditions: Acquired Brain Injury

• Registration Number: NCT04860973
• Lead Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

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

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 Timeline

• Study First Submitted: 2020-09-08
• Study Start: 2021-02-11
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Primary Completion: 2023-05-16
• Study Completion: 2023-05-16
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment	12 months	Proportion of eligible candidates recruited within the time frame

Trial Locations

Locations (1)

University Hospitals of Derby & Burton NHS Foundation Trust; 🇬🇧 Derby, United Kingdom