Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of 3 methods of continuous positive airway pressure titration for obstructive sleep apnoea
Scientific title
Manual laboratory continuous positive airway presssure (CPAP) titration compared to laboratory and home autotitration to assess compliance and clinical response among people with obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 2119 0
Condition category
Condition code
Respiratory 2214 2214 0 0
Sleep apnoea

Study type
Description of intervention(s) / exposure
3 CPAP titration methods are compared in terms of clinical and physiological response to treatment at 1 month. Patients are randomised to a one of 3 different interventions. The intervention is one of 3 ways of determining the pressure for a patient's CPAP machine. This intervention occurs on the first night of treatment, i.e., during a night of sleep. The intervention compares one of 3 ways to determine the pressure or air needed during sleep to control obstructive sleep apnoea. The manual titration method involves a technologist monitoring the sleep of the patient while pressure is varied. The autotitration can be done in the laboratory or at home. The machine varies the pressure rather than the sleep technologist and provides a recommended pressure dependent on the changes in airflow as pressure is changed. In the laboratory autotitration the technologist can still help the patient if there are problems, eg a dry mouth, while pressure is applied. Assessments are made after one month on CPAP treatment at the pressure detemined above. Assessments are clinical questionnaire measures of sleepiness, quality of life, cognitive function and blood pressure are measured during the day and control of OSA is measured by monitoring during sleep in the sleep laboratory while on CPAP treatment.
Intervention code [1] 1467 0
Treatment: Devices
Comparator / control treatment
The control group is the manual CPAP titration group. This is considered the reference standard of CPAP titration.
Control group

Primary outcome [1] 3067 0
CPAP compliance
Timepoint [1] 3067 0
1 month
Primary outcome [2] 3068 0
Change in Epworth Sleepiness Scale compared to before treatment
Timepoint [2] 3068 0
1 month
Secondary outcome [1] 5149 0
Quality of life (Short Form 36 questionnaire)
Timepoint [1] 5149 0
1 month
Secondary outcome [2] 5150 0
Control of sleep disordered breathing (apnoea/hypopnoea index on CPAP)
Timepoint [2] 5150 0
1 month

Key inclusion criteria
Symptoms of obstructive sleep apnoea that would respond to CPAP therapy, Apnoea/hypopnoea index>15, Epwortth Sleepiness Scale at least 8.
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Body Mass Indes (BMI)>45kg/m2, Periodic leg movement index >15 events/hr slept, Predominant central sleep apnoea (>50% central apnoeas), Respiratory failure from any cause, Significant lung or heart disease, recent stroke, neuromuscular disease, Other severe medical illness or acutely unwell, Unable to comprehend the study, eg: because of language difficulties.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation (eligible for public funding of CPAP treatment or not), using a computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
principal therapist (sleep physician reviewing patient, and determining the pressure from the titration night), assessor and data analyst
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 746 0

Funding & Sponsors
Funding source category [1] 2373 0
Name [1] 2373 0
Western Australian Sleep Disorders Research Institute
Address [1] 2373 0
Hospital Ave, Queen Elizabeth II Medical Centre, Nedlands. W.A. 6009.
Country [1] 2373 0
Funding source category [2] 3037 0
Commercial sector/Industry
Name [2] 3037 0
Res Med Ltd
Address [2] 3037 0
97 Waterloo Rd, North Ryde, NSW, 2113.
Country [2] 3037 0
Primary sponsor type
Western Australian Sleep Disorders Institute
Hospital Ave, Queen Elizabeth II Medical Centre, Nedlands. W.A. 6009
Secondary sponsor category [1] 2149 0
Name [1] 2149 0
Western Australian Sleep Disorders Research Institute
Address [1] 2149 0
Hospital Ave, Queen Elizabeth II Medical Centre, Nedlands. W.A. 6009
Country [1] 2149 0
Secondary sponsor category [2] 2738 0
Name [2] 2738 0
Address [2] 2738 0
Country [2] 2738 0

Ethics approval
Ethics application status
Ethics committee name [1] 4197 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 4197 0
Ethics committee country [1] 4197 0
Date submitted for ethics approval [1] 4197 0
Approval date [1] 4197 0
Ethics approval number [1] 4197 0
Ethics committee name [2] 4198 0
Western Australian Sleep Disorders Institute
Ethics committee address [2] 4198 0
Ethics committee country [2] 4198 0
Date submitted for ethics approval [2] 4198 0
Approval date [2] 4198 0
Ethics approval number [2] 4198 0

Brief summary
The best way of determining a CPAP pressure to control sleep apnoea is not known. We are comparing 3 common methods of determining this pressure and assessing the effect on the compliance with CPAP and response to therapy
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 27401 0
Address 27401 0
Country 27401 0
Phone 27401 0
Fax 27401 0
Email 27401 0
Contact person for public queries
Name 10656 0
Nigel McArdle
Address 10656 0
Western Australian Sleep Disorders Research Institute
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA
Country 10656 0
Phone 10656 0
08 93462422
Fax 10656 0
08 93462822
Email 10656 0
Contact person for scientific queries
Name 1584 0
Nigel McArdle
Address 1584 0
Western Australian Sleep Disorders Research Institute
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA
Country 1584 0
Phone 1584 0
08 93462422
Fax 1584 0
08 93462822
Email 1584 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary