eural Repair and Sleep in Traumatic Brain Injury ('TBI'): an observational study to investigate the recovery of sleep after TBI.

Not Applicable

Suspended

• Conditions: traumatic brain injury, TBI; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12617001232325
• Lead Sponsor: Royal Rehab Brain Injury Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-23
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Age 16 years and over at injury; treated in a non-paediatric healthcare system; a blunt head trauma with a clear description of injury for head trauma; current inpatient in a public hospital; neuroimaging with CT and, or, MRI brain performed at 4 weeks or less following injury and images or reports are available for viewing.

Exclusion Criteria

Restless or disruptive behaviour; psychiatric instability.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSG / EEG - arousal index for sleep fragmentation; heart rate variability; sleep-related breathing disorder[Every two weeks from recruitment until 6 weeks following resolution of PTA];Executive domain of NUCOG[Every two weeks from recruitment until 6 weeks following resolution of PTA]

Secondary Outcome Measures

Name	Time	Method
Comprehensive and Brief ICF Core Sets for TBI modified<br>[Every two weeks from recruitment until 6 weeks following resolution of PTA];The Cognitive-Log[Every two weeks from recruitment until 6 weeks following resolution of PTA];Hospital Anxiety and Depression Score modified[Every two weeks from recruitment until 6 weeks following resolution of PTA];Insomnia Severity Index modified[ Every two weeks from recruitment until 6 weeks following resolution of PTA];Satisfaction with Life Scale modified. [ Every two weeks from recruitment until 6 weeks following resolution of PTA];Glasgow Outcome Score - Extended[Every two weeks from recruitment until 6 weeks following resolution of PTA];4AT modified[Every two weeks from recruitment until 6 weeks following resolution of PTA];Sleep Diary modified[ Every two weeks from recruitment until 6 weeks following resolution of PTA]