Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000799651
Ethics application status
Approved
Date submitted
6/12/2005
Date registered
20/12/2005
Date last updated
21/06/2018
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
COSAQ
Secondary ID [2] 262989 0
COSAQ
Secondary ID [3] 263008 0
COSAQ
Universal Trial Number (UTN)
Trial acronym
COSAQ
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
17/09/2009
Date of last participant enrolment
Anticipated
Actual
1/10/2015
Date of last data collection
Anticipated
Actual
29/01/2016
Sample size
Target
150
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 248 0
Canada
State/province [1] 248 0
British Columbia
Country [2] 249 0
United Kingdom
State/province [2] 249 0
Multiple

Funding & Sponsors
Funding source category [1] 1130 0
Charities/Societies/Foundations
Name [1] 1130 0
Victorian Neurotrauma Initiative
Country [1] 1130 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Bowen Centre. Austin Health
PO Box 5555. Heidelberg Vic. 3084
Country
Australia
Secondary sponsor category [1] 987 0
None
Name [1] 987 0
please delete me
Address [1] 987 0
please delete me - web site can't
Country [1] 987 0
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 293993 0
Approval date [1] 293993 0
27/05/2009
Ethics approval number [1] 293993 0
H2009/03509

Summary
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
www.shiq.com.au
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

Contacts
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
Australia
Phone 36330 0
+61394963871
Fax 36330 0
Email 36330 0
david.berlowitz@austin.org.au
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
Australia
Phone 9975 0
+61 3 94963688
Fax 9975 0
Email 9975 0
david.berlowitz@austin.org.au
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
Australia
Phone 903 0
+61 3 94963688
Fax 903 0
Email 903 0
david.berlowitz@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPositive airway pressure for sleep-disordered breathing in acute quadriplegia: a randomised controlled trial2018https://doi.org/10.1136/thoraxjnl-2018-212319
Dimensions AIAuto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ): study protocol for a randomized controlled trial2013https://doi.org/10.1186/1745-6215-14-181
N.B. These documents automatically identified may not have been verified by the study sponsor.