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Trial registered on ANZCTR


Registration number
ACTRN12615000069550
Ethics application status
Approved
Date submitted
23/12/2014
Date registered
27/01/2015
Date last updated
8/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Cooperative Research Centre (CRC) for Alertness, Safety and Productivity: Respiratory Phenotyping for Obstructive Sleep Apnoea
Scientific title
Efficacy and acceptability of oxygen versus CPAP treatment for people who have obstructive sleep apnoea known to respond to oxygen therapy
Secondary ID [1] 285779 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CRC RPOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 293661 0
Condition category
Condition code
Respiratory 293959 293959 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxygen therapy delivered via nasal cannulae
Dose: 4L/min via an oxygen concentrator (~93% oxygen)
Frequency and duration of administration: One month, each night during sleep for as close as possible to the entire sleep period.
Period between treatments: Approximately one week
Setting for use of oxygen therapy: Participant's home
Intervention code [1] 290738 0
Treatment: Devices
Comparator / control treatment
Continuous Positive Airways Pressure (CPAP)
Dose: Therapeutic pressure for the individual, determined in a prior CPAP titration study (as per standard medical care).
Duration/frequency: One month, each night during sleep for as close as possible to the entire sleep period.
Mode of administration: Via clinically fitted CPAP face mask.
Setting for use of oxygen therapy: Participant's home
Control group
Active

Outcomes
Primary outcome [1] 293732 0
Treatment “success,” measured as Apnea–hypopnea index (AHI), independent of oxygen desaturation, on treatment x adherence (average device use hours/night) x patient treatment satisfaction measured on a linear scale
Timepoint [1] 293732 0
At the conclusion of one month of CPAP therapy and at the conclusion of one month of oxygen therapy (order of therapy to be determined randomly).
Secondary outcome [1] 311692 0
Adherence to treatment (device measured average hours of use over one month)
Timepoint [1] 311692 0
At the conclusion of one month of CPAP therapy and at the conclusion of one month of oxygen therapy (order of therapy to be determined randomly).
Secondary outcome [2] 311693 0
Polysomnogram (PSG) sleep time spent in sleep disordered breathing
Timepoint [2] 311693 0
During overnight sleep study at the conclusion of each month of therapy.
Secondary outcome [3] 311694 0
Change in sleepiness (Epworth Sleepiness Scale)
Timepoint [3] 311694 0
At the conclusion of one month of CPAP therapy and at the conclusion of one month of oxygen therapy (order of therapy to be determined randomly).
Secondary outcome [4] 311695 0
Change in average sleep end-tidal or transcutaneous CO2 (ETCO2 or TcCO2) measured using dual pressure/CO2 sampling catheter.
Timepoint [4] 311695 0
At the conclusion of one month of CPAP therapy and at the conclusion of one month of oxygen therapy (order of therapy to be determined randomly) during an overnight study.

Eligibility
Key inclusion criteria
- Diagnosed with obstructive sleep apnoea (OSA)
- Recommended usual care with CPAP treatment by their treating physician
- Demonstrated positive treatment response to one night of oxygen therapy (O2 AHI <10 /hr with a =50% reduction compared to the air control night; using modified AHI scoring criteria without SaO2 signal blinding and no desaturation criteria).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Smokers (due to risk of fire with home oxygen use)
- Women who are pregnant or who are trying to conceive
- Children and/or young people (i.e. < 18 years)
- Central sleep apnea (central apnea index >5 /hr)
- Any relevant significant co-morbidity including respiratory (COPD) or psychiatric disorders likely to place the patient at higher than normal risk or likely to confound experimental treatment outcomes.
- Physician recommended exclusion
- Patient unable (e.g. language difficulties) or unwilling to consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2015
Actual
9/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 290341 0
Other Collaborative groups
Name [1] 290341 0
CRC for Alertness Safety and Productivity
Country [1] 290341 0
Australia
Primary sponsor type
Individual
Name
A/Prof Peter Catcheside
Address
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Road
Daw Park, 5041
South Australia
Country
Australia
Secondary sponsor category [1] 289063 0
University
Name [1] 289063 0
Flinders University
Address [1] 289063 0
Postal Address
Research Services Office
Flinders University
GPO Box 2100
Adelaide SA 5001
Country [1] 289063 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292079 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 292079 0
The Flats, G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 292079 0
Australia
Date submitted for ethics approval [1] 292079 0
24/11/2014
Approval date [1] 292079 0
05/03/2015
Ethics approval number [1] 292079 0
20.15

Summary
Brief summary
Study hypothesis: Current clinical management of OSA is to use continuous positive airways pressure (CPAP) as a first-line treatment, and CPAP is approved in Australia for this purpose. Some people find CPAP difficult to tolerate and sleep with, so other treatments may be useful. Oxygen therapy is one form of treatment that could potentially treat OSA patients with unstable breathing control as the key factor underlying OSA.

Primary purpose: The aim of this study is to test if oxygen therapy is an effective and acceptable alternative treatment to CPAP for patients with unstable breathing control underlying their OSA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53238 0
A/Prof Peter Catcheside
Address 53238 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Rd
Daw Park, 5041
South Australia
Country 53238 0
Australia
Phone 53238 0
+ 61 8 8275 1187
Fax 53238 0
Email 53238 0
Peter.Catcheside@health.sa.gov.au
Contact person for public queries
Name 53239 0
A/Prof Peter Catcheside
Address 53239 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Rd
Daw Park, 5041
South Australia
Country 53239 0
Australia
Phone 53239 0
+ 61 8 8275 1187
Fax 53239 0
Email 53239 0
Peter.Catcheside@health.sa.gov.au
Contact person for scientific queries
Name 53240 0
A/Prof Peter Catcheside
Address 53240 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Rd
Daw Park, 5041
South Australia
Country 53240 0
Australia
Phone 53240 0
+ 61 8 8275 1187
Fax 53240 0
Email 53240 0
Peter.Catcheside@health.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

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