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Trial registered on ANZCTR


Registration number
ACTRN12617001232325
Ethics application status
Approved
Date submitted
18/08/2017
Date registered
23/08/2017
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Neural Repair and Sleep in Traumatic Brain Injury ('TBI'): an observational study to investigate the recovery of sleep after TBI.
Scientific title
Neural Repair and Sleep in Traumatic Brain Injury ('TBI'): an observational study to investigate the recovery of sleep after TBI.
Secondary ID [1] 292686 0
None
Universal Trial Number (UTN)
U1111-1200-9482
Trial acronym
NRSleepTBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury, TBI 304435 0
Condition category
Condition code
Neurological 303764 303764 0 0
Other neurological disorders
Injuries and Accidents 303765 303765 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 303766 303766 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study of sleep in traumatic brain injury (TBI) in the inpatient rehabilitation setting. The study will seek to study sleep fragmentation and its recovery over time in TBI. The study will also examine the effect of sleep fragmentation and self-reported sleep quality on cognition, behaviour, mood, disability and life satisfaction.

Polysomonography (PSG) with electroencephalography (EEG) assessments with clinical assessments will be repeated fortnightly for up to 6 weeks following post-traumatic amnesia (PTA) resolution. If PSG with EEG is not feasible, an overnight pulse oximetry will be offered.
Intervention code [1] 298920 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303135 0
PSG / EEG - arousal index for sleep fragmentation; heart rate variability; sleep-related breathing disorder
Timepoint [1] 303135 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Primary outcome [2] 303165 0
Executive domain of NUCOG
Timepoint [2] 303165 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Secondary outcome [1] 337992 0
Comprehensive and Brief ICF Core Sets for TBI modified
Timepoint [1] 337992 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Secondary outcome [2] 338037 0
The Cognitive-Log
Timepoint [2] 338037 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Secondary outcome [3] 338074 0
Hospital Anxiety and Depression Score modified
Timepoint [3] 338074 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Secondary outcome [4] 338077 0
Insomnia Severity Index modified
Timepoint [4] 338077 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Secondary outcome [5] 338078 0
Satisfaction with Life Scale modified.
Timepoint [5] 338078 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Secondary outcome [6] 338081 0
Glasgow Outcome Score - Extended
Timepoint [6] 338081 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Secondary outcome [7] 338082 0
4AT modified
Timepoint [7] 338082 0
Every two weeks from recruitment until 6 weeks following resolution of PTA
Secondary outcome [8] 338083 0
Sleep Diary modified
Timepoint [8] 338083 0
Every two weeks from recruitment until 6 weeks following resolution of PTA

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Restless or disruptive behaviour; psychiatric instability.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics and correlation between the pre-defined endpints using non-parametric analyses with p value for statistical significance at <0.05. Minimum important change (MIC) for sleep fragmentation is been defined as a 20% decrease from the baseline arousal index, and in executive functioning is defined as a 20% change in score for Executive domain, NUCOG.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8829 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 16957 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 297327 0
Charities/Societies/Foundations
Name [1] 297327 0
RACP Foundation
Address [1] 297327 0
Royal Australasian College of Physicians
145 Macquarie Street Sydney NSW 2000
Country [1] 297327 0
Australia
Primary sponsor type
Hospital
Name
Royal Rehab Brain Injury Unit
Address
235 Morrison Road Ryde NSW 2112
Country
Australia
Secondary sponsor category [1] 296300 0
Other Collaborative groups
Name [1] 296300 0
Woolcock Institute of Medical Research
Address [1] 296300 0
431 Glebe Point Rd, Glebe NSW 2037
Country [1] 296300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298429 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 298429 0
Research Office
Kolling Building, Level 13
Royal North Shore Hospital
St Leondards NSW 2065
Ethics committee country [1] 298429 0
Australia
Date submitted for ethics approval [1] 298429 0
27/02/2017
Approval date [1] 298429 0
24/05/2017
Ethics approval number [1] 298429 0
RESP/17/48; HREC/17/HAWKE/60

Summary
Brief summary
The purpose of this study is to investigate the brain signalling in sleep after TBI. We want to know if sleep problems improve as time passes after the brain injury, and whether the recovery of sleep, sleep quality, and cognition are related. It is also possible that some patients after a severe TBI have breathing problems in sleep. It is possible that breathing problems in sleep could affect their recovery. The sleep study will include monitoring for breathing disorders during sleep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77054 0
Dr Pearl Chung
Address 77054 0
Royal Rehab
235 Morrison Road Ryde NSW 2112
Country 77054 0
Australia
Phone 77054 0
+61 2 9808 9222
Fax 77054 0
Email 77054 0
pearl.chung@royalrehab.com.au
Contact person for public queries
Name 77055 0
Dr Pearl Chung
Address 77055 0
Royal Rehab
235 Morrison Road Ryde NSW 2112
Country 77055 0
Australia
Phone 77055 0
+61 2 9808 9222
Fax 77055 0
Email 77055 0
pearl.chung@royalrehab.com.au
Contact person for scientific queries
Name 77056 0
Dr Pearl Chung
Address 77056 0
Royal Rehab
235 Morrison Road Ryde NSW 2112
Country 77056 0
Australia
Phone 77056 0
+61 2 9808 9222
Fax 77056 0
Email 77056 0
pearl.chung@royalrehab.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not originally included in the ethics application.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable