Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000064606
Ethics application status
Approved
Date submitted
28/07/2005
Date registered
1/08/2005
Date last updated
1/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a simplified management strategy in OSA
Scientific title
A randomised cphase 3 study to evaluate the efficacy of a simplified diagnostic and management system in management of obstructive sleep apnoea (OSA), comparing outcomes (improvement in daytime sleepiness) against best current practice
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
OSA 136 0
Condition category
Condition code
Respiratory 155 155 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group is group of patients with moderate-severe OSA, to whom a simplified diagnostic (home and oximetry) and management system (Specialist nurse led application of home, autoset continuous positive airway pressure) was applied.
Intervention code [1] 74 0
Treatment: Devices
Comparator / control treatment
The control group is a group of patients with moderate -severe OSA, to whom best current clinical practice (sleep physician supervised, sleep lab used for sleep studies and CPAP application) was applied.
Control group
Active

Outcomes
Primary outcome [1] 191 0
ESS change (Epworth sleepiness score, a subjective measure of daytime sleepiness)
Timepoint [1] 191 0
Measured at each visit, but most importantly at the final visit
Secondary outcome [1] 443 0
MWT is Maintenance of wakefulness Test, an objective measure of a person’s ability to maintain wakefulness.
Timepoint [1] 443 0
Secondary outcome [2] 444 0
Neurocognitive testing of patients
Timepoint [2] 444 0
Will be performed before and after their trial of Continuous Positive Airway Pressure (CPAP).

Eligibility
Key inclusion criteria
ESS 8+2 or more symtoms of OSA
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
CSRCVA in last 12 monthsactive psychiatric disease

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)
Randomisation was centralised, with sealed envelopes being used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software was used to generate the randomisation sequence, blocking was used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 207 0
Government body
Name [1] 207 0
NHMRC
Country [1] 207 0
Australia
Funding source category [2] 208 0
Commercial sector/Industry
Name [2] 208 0
RESMED
Country [2] 208 0
Australia
Funding source category [3] 209 0
Other
Name [3] 209 0
Integneuro
Country [3] 209 0
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 156 0
Commercial sector/Industry
Name [1] 156 0
RESMED
Address [1] 156 0
Country [1] 156 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 971 0
Alfred
Ethics committee address [1] 971 0
Ethics committee country [1] 971 0
Australia
Date submitted for ethics approval [1] 971 0
Approval date [1] 971 0
Ethics approval number [1] 971 0
Ethics committee name [2] 972 0
Royal Newcastle
Ethics committee address [2] 972 0
Ethics committee country [2] 972 0
Australia
Date submitted for ethics approval [2] 972 0
Approval date [2] 972 0
Ethics approval number [2] 972 0
Ethics committee name [3] 973 0
Repatriation General Hospital
Ethics committee address [3] 973 0
Ethics committee country [3] 973 0
Australia
Date submitted for ethics approval [3] 973 0
Approval date [3] 973 0
Ethics approval number [3] 973 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36323 0
Address 36323 0
Country 36323 0
Phone 36323 0
Fax 36323 0
Email 36323 0
Contact person for public queries
Name 9263 0
Nick Antic
Address 9263 0
Repatriation General Hospital
202-216 Daws Rd
Daw Park SA 5041
Country 9263 0
Australia
Phone 9263 0
+61 8 82769666
Fax 9263 0
+61 8 82776890
Email 9263 0
nick.antic@rgh.sa.gov.au
Contact person for scientific queries
Name 191 0
Nick Antic
Address 191 0
Repatriation General Hospital
202-216 Daws Rd
Daw Park SA 5041
Country 191 0
Australia
Phone 191 0
+61 8 82769666
Fax 191 0
+61 8 82776890
Email 191 0
nick.antic@rgh.sa.gov.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
No additional documents have been identified.