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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, randomised controlled trial of auto-titrating Continuous positive airway pressure treatment for Obstructive Sleep Apnoea after acute Quadriplegia
Scientific title
A prospective, randomised controlled trial of auto-titrating Continuous positive airway pressure treatment for Obstructive Sleep Apnoea after acute Quadriplegia
Secondary ID [1] 262976 0
Secondary ID [2] 262989 0
Secondary ID [3] 263008 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute tetraplegia 958 0
Obstructive Sleep Apnoea 4680 0
Condition category
Condition code
Neurological 1027 1027 0 0
Other injuries and accidents
Musculoskeletal 1028 1028 0 0
Other injuries and accidents

Study type
Description of intervention(s) / exposure
Three months of nightly, nocturnal continuous positive airway pressure and usual care. The devices are auto-titrating, therefore the amount of pressure delivered is that which is sufficient to maintain a patent upper airway during sleep. Usual care is all other care provide to those with acute tetraplegia. This may include treatment for low lung volumes and retention of lung secretions.
Intervention code [1] 786 0
Treatment: Devices
Comparator / control treatment
Three months of nocturnal, usual care alone
Control group

Primary outcome [1] 1378 0
Neurocognitive performance
Timepoint [1] 1378 0
After three months of therapy
Secondary outcome [1] 2440 0
Daytime, state sleepiness; Karolinska Sleepiness Scale score
Timepoint [1] 2440 0
Weekly for 3 months.
Secondary outcome [2] 287957 0
Respiratory function (spirometry)
Timepoint [2] 287957 0
Monthly (baseline, 1, 2 and 3 months)
Secondary outcome [3] 287958 0
Quality of Life. Measured with the Assessment of Quality of Life measure
Timepoint [3] 287958 0
Baseline and 3 months
Secondary outcome [4] 287959 0
Sleepiness and sleep symptoms. Basic Nordic Sleep Questionnaire
Timepoint [4] 287959 0
Baseline and 3 months
Secondary outcome [5] 287960 0
Anxiety and Depression. Hospital Depression and Anxiety Scale
Timepoint [5] 287960 0
Baseline and 3 months
Secondary outcome [6] 287961 0
Mood. Profile of Mood States
Timepoint [6] 287961 0
Baseline and 3 months

Key inclusion criteria
Acute, traumatic quadriplegia. Obstructive Sleep Apnoea confirmed on full polysomnography. Able to tolerate at least four hours of CPAP use on at least one of first three nights on which the device is trialled.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Successful CPAP therapy for OSA prior to injury
Significant head injury (Glascow Coma Score < 8 at first assessment)
Ongoing hypercapnic ventilatory failure (PaCO2 > 45 mmHg at randomisation)
Likely inability to be followed up until 3 months
Condition likely to significantly limit CPAP use (eg major psychoses, facial or base of skull fractures, etc)

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consent and enrolment occur at each trial site. Randomization is performed centrally through the trial website. The randomization sequence is sequentially numbered and opaque to all investigators prior to randomization. Computer/website access logs are maintained for all randomization procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3 / Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 248 0
State/province [1] 248 0
British Columbia
Country [2] 249 0
United Kingdom
State/province [2] 249 0

Funding & Sponsors
Funding source category [1] 1130 0
Name [1] 1130 0
Victorian Neurotrauma Initiative
Address [1] 1130 0
PO Box 2314, Geelong 3220
Country [1] 1130 0
Primary sponsor type
Institute for Breathing and Sleep
Bowen Centre. Austin Health
PO Box 5555. Heidelberg Vic. 3084
Secondary sponsor category [1] 987 0
Name [1] 987 0
please delete me
Address [1] 987 0
please delete me - web site can't
Country [1] 987 0

Ethics approval
Ethics application status
Ethics committee name [1] 293993 0
Austin Heath Human Ethics
Ethics committee address [1] 293993 0
Austin Health
Studley Rd. Heidelberg 3084 Vic
Ethics committee country [1] 293993 0
Date submitted for ethics approval [1] 293993 0
Approval date [1] 293993 0
Ethics approval number [1] 293993 0

Brief summary
The COSAQ trial aims to establish the impact on sleep function of using a CPAP nasal mask and pump at night.

Continuous positive airway pressure (CPAP) is a nasal/facial mask and machine used at night to treat sleep apnoea. Although CPAP is the usual treatment for sleep apnoea, previous reports suggest that is poorly tolerated in acute quadriplegia. A maximum of 35% of those with chronic quadriplegia are adherent with therapy, with a higher rate of 50% in acute quadriplegia. A range of factors including severe immobility and psychological factors appear to contribute to a low acceptance of CPAP.

The SHiQ COSAQ project will examine the impact on sleep function, quality of life and cognition of using CPAP, and establish whether the benefit of using CPAP is outweighed by the inconvenience of using it.

People with quadriplegia have extremely high rates of sleep apnoea after injury which is undoubtedly limiting their rehabilitation. Successful treatment may improve acute, sub-acute and community outcomes for this group and demonstrate significant cost-utility.
Trial website
Trial related presentations / publications
Berlowitz DJ for the COSAQ Collaborative. “A randomized controlled trial of auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ).” European Respiratory Society 2016 International Congress. London, United Kingdom. September 2016.
Public notes

Principal investigator
Name 36330 0
A/Prof David Berlowitz
Address 36330 0
Bowen Centre. Austin Health,
PO Box 5555. Heidelberg Vic 3084
Country 36330 0
Phone 36330 0
Fax 36330 0
Email 36330 0
Contact person for public queries
Name 9975 0
A/Prof David Berlowitz
Address 9975 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidleberg VIC 3084
Country 9975 0
Phone 9975 0
+61 3 94963688
Fax 9975 0
Email 9975 0
Contact person for scientific queries
Name 903 0
A/Prof David Berlowitz
Address 903 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidleberg VIC 3084
Country 903 0
Phone 903 0
+61 3 94963688
Fax 903 0
Email 903 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary