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Trial registered on ANZCTR


Registration number
ACTRN12611001250921
Ethics application status
Approved
Date submitted
1/12/2011
Date registered
6/12/2011
Date last updated
2/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of auto-titrating positive airways pressure in the management of treatment-related aerophagia.
Scientific title
Assessment of auto-titrating positive airways pressure in the management of treatment-related aerophagia and its impact on usage and quality of life measures.
Secondary ID [1] 273346 0
None
Universal Trial Number (UTN)
U1111-1125-6987
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea 279131 0
Condition category
Condition code
Respiratory 279306 279306 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be assigned to using an auto-titrating positive airways pressure device overnight for 2 weeks. Auto-titrating positive airways pressure devices treat obstructive sleep apnea by delivering pressurised air via a hose to a mask interface. It delivers the pressure by sensing when the airway closes and only increasing the pressure if necessary. This is a crossover study and there is no washout period between treatments.
Intervention code [1] 283688 0
Treatment: Devices
Comparator / control treatment
Patients will be assigned to using a continuous positive airways pressure device worn overnight for 2 weeks.

Continuous positive airway pressure is the recognised gold standard treatment for obstructive sleep apnea. It treats obstructive sleep apnea by delivering a fixed amount of pressurised air via a hose to a mask interface; splinting the airway which prevents its closure during sleep. The fixed amount of air will vary according to each participant and remain fixed on a certain dose for each of those participants during this period.
Control group
Active

Outcomes
Primary outcome [1] 279917 0
The primary outcome measure is usage. Usage is the amount of time participants use the treatment device.
Timepoint [1] 279917 0
Usage is measured after 2 weeks of each treatment.
Secondary outcome [1] 294774 0
Visual Analogue Scale data to measure the presence and severity of bloating.
Timepoint [1] 294774 0
Measured at at the start of the trial and after 2 weeks of each treatment.
Secondary outcome [2] 294775 0
Visual Analogue Scale data to measure the presence and severity of abdominal pain/ discomfort
Timepoint [2] 294775 0
Measured at at the start of the trial and after 2 weeks of each treatment.
Secondary outcome [3] 294776 0
Visual Analogue Scale data to measure the presence and severity of flatulence
Timepoint [3] 294776 0
Measured at at the start of the trial and after 2 weeks of each treatment.

Eligibility
Key inclusion criteria
Patients who have reported symptoms of aerophagia whilst on continuous positive airways pressure therapy for obstructive sleep apnea.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women and patients with intellectual or mental impairment.

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)
Patients who are seen in the Sleep Disorders Centre who are on CPAP therapy and have aerophagia as a side-effect of this therapy will be asked to participate. Patients will have the study explained to them and given a Participant Information Sheet. If agreeable, they will then be asked to sign the Consent Form which will be kept in the Sleep Disorders Centre. Patients will be assigned to the two treatment options in random order. The randomisation was carried out in the Microsoft Excel software package using the Random number function. One researcher will remain unblinded and will carry out the randomisation process. This researcher will not have any interaction with participants for the duration of the trial. Two of the researchers will remain blinded to which treatment arm the participant has been assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated with allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Random order crossover design.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 284181 0
Government body
Name [1] 284181 0
Queensland Health - Health Practitioner Research Scheme 2009-2010
Address [1] 284181 0
Allied Health and Oral Health Clinical Education and Training Unit
3rd Floor, Forestry House, 130 Mary Street
GPO Box 48, Brisbane Queensland 4001
Country [1] 284181 0
Australia
Primary sponsor type
Hospital
Name
The Princess Alexandra Hospital
Address
199 Ipswich Road
Woolloongabba
Queensland
4102
Country
Australia
Secondary sponsor category [1] 269137 0
None
Name [1] 269137 0
Address [1] 269137 0
Country [1] 269137 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286142 0
Princess Alexandra Human Research Ethics Committee
Ethics committee address [1] 286142 0
Human Research Ethics Committee
Centres for Health Research
Princess Alexandra Hospital
199 Ipswich Road Woolloongabba
Queensland
4102
Ethics committee country [1] 286142 0
Australia
Date submitted for ethics approval [1] 286142 0
Approval date [1] 286142 0
23/04/2009
Ethics approval number [1] 286142 0
2009/088

Summary
Brief summary
Patients who suffer from Obstructive Sleep Apnoea, a disorder where the airway closes during sleep, are often prescribed treatment with CPAP (Continuous Positive Airways Pressure). This is a device that blows air down the airway via a face mask. Some patients experience stomach bloating as a result of this therapy. This research aims to try an alternative treatment, APAP (Automatic Positive Airways Pressure), to assess if this is better tolerated in these patients. APAP delivers the pressure by sensing when the airway closes and only increasing if necessary. Patients will use CPAP for two weeks and APAP for two weeks (in random order) to see which treatment is best tolerated. We propose that treatment with APAP will result in more effective and comfortable therapy. Patients who currently discontinue or struggle with CPAP due to these side-effects will have a reasonable alternative.
Trial website
Trial related presentations / publications
22nd Annual Scientific Meeting of the Australasian Sleep Association and Australasian Sleep Technologists Association, Christchurch, New Zealand, 21-23 October 2010: Poster presentation with oral component.

Queensland Branch of the Australasian Sleep Technologists Association November 2009: Oral presentation
Public notes

Contacts
Principal investigator
Name 33361 0
Address 33361 0
Country 33361 0
Phone 33361 0
Fax 33361 0
Email 33361 0
Contact person for public queries
Name 16608 0
Moses Chikazaza
Address 16608 0
Sleep Disorders Centre
Princess Alexandra Hospital
Ipswich road
Woolloongabba Queensland 4102
Country 16608 0
Australia
Phone 16608 0
+61 7 3176 5751
Fax 16608 0
+61 7 3176 7096
Email 16608 0
moses_chikazaza@health.qld.gov.au
Contact person for scientific queries
Name 7536 0
Moses Chikazaza
Address 7536 0
Sleep Disorders Centre
Princess Alexandra Hospital
Ipswich road
Woolloongabba Queensland 4102
Country 7536 0
Australia
Phone 7536 0
+61 7 3176 5751
Fax 7536 0
+61 7 3176 7096
Email 7536 0
moses_chikazaza@health.qld.gov.au

No data has been provided for results reporting
Summary results
Not applicable