Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000441617
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
20/09/2005
Date last updated
20/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of a CO2 clamp and or CPAP to stabilize respiration in patients with combined central and obstructive sleep apnoea
Scientific title
Use of a CO2 clamp and or CPAP to stabilize respiration in patients with combined central and obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central and Obstructive sleep apnoea 553 0
Condition category
Condition code
Respiratory 631 631 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To test efficacy of device under development in treating combined central and obstructive sleep apnoea as compared to conventional CPAP as control. The subject will undergo one night polysomnography whilst using device and one night polysomnography with CPAP (control) in randomized order 1 week apart. The subject will be requested to wear CPAP at night for one week at home prior to each study night to acclimatize to positive airway pressure and mask.
Intervention code [1] 524 0
Treatment: Devices
Comparator / control treatment
Conventional CPAP as control.
Control group
Active

Outcomes
Primary outcome [1] 740 0
Resolution of sleep disordered breathing whilst on aforementioned device, compared with placebo (CPAP alone)
Timepoint [1] 740 0
Measured on overnight polysomnography (one night)
Secondary outcome [1] 1520 0
Improvement of overnight oxygenation and arousal index as measured by overnight polysomnography (one night) whilst on aforementioned device, compared with placebo.
Timepoint [1] 1520 0

Eligibility
Key inclusion criteria
Presence of central and or obstructive sleep apnoea. Clinically stable 1 month. Willing and competent to sign consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant psychiatric disease. Claustrophobia. inability to tolerate CPAP via mask overnight.

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)
Intervention is concealed from subject as they are unaware which device is active
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 690 0
Self funded/Unfunded
Name [1] 690 0
Country [1] 690 0
Primary sponsor type
Individual
Name
Dr R Ratnavadivel, Adelaide Institute for Sleep Health, Daws Rd, Daw Park SA 5041
Address
Country
Australia
Secondary sponsor category [1] 577 0
Individual
Name [1] 577 0
Professor RD McEvoy
Address [1] 577 0
Adelaide Institute for Sleep Health
Daws Rd
Daw Park SA 5041
Country [1] 577 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1892 0
Repatriation General Hospital
Ethics committee address [1] 1892 0
Ethics committee country [1] 1892 0
Australia
Date submitted for ethics approval [1] 1892 0
Approval date [1] 1892 0
Ethics approval number [1] 1892 0

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

Contacts
Principal investigator
Name 35747 0
Address 35747 0
Country 35747 0
Phone 35747 0
Fax 35747 0
Email 35747 0
Contact person for public queries
Name 9713 0
Dr Rajeev ratnavadivel
Address 9713 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9713 0
Australia
Phone 9713 0
+61 8 82751187
Fax 9713 0
+61 8 82769666
Email 9713 0
[email protected]
Contact person for scientific queries
Name 641 0
Dr Rajeev ratnavadivel
Address 641 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 641 0
Australia
Phone 641 0
+61 8 82751187
Fax 641 0
+61 8 82769666
Email 641 0
[email protected]

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.