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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
Scientific title
A Study to Validate a Novel Auto Continuous Positive Airway Pressure Therapy
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Study type
Description of intervention(s) / exposure
Treatment: Devices - SPAP
Treatment: Devices - CPAP

Active Comparator: Continuous positive airway pressure (CPAP) device. - Standard CPAP therapy

Experimental: Auto-CPAP device (SPAP). - Novel Auto-CPAP algorithm

Treatment: Devices: SPAP
Novel Auto-algorithm for Auto-CPAP device

Treatment: Devices: CPAP
Standard CPAP therapy

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
AHI - The apnea hypopnea index (AHI) is a measure of sleep disordered breathing. It will be measured and compared between the two groups. The units are number of events per hour.
Timepoint [1] 0 0
one post study night (once PSG is scored)

Key inclusion criteria
- Aged =18 years with mild-to-severe OSA (Apnea Hypopnea Index equal to or greater than
5 per hour).
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Any medical condition which contraindicates (see Appendix A) the use of CPAP or

- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).

- Unstable psychiatric disease.

- Other significant sleep disorder.

- Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined
by the investigation investigator.

- Any known factor or disease that might interfere with treatment compliance,
investigation conduct or interpretation of the results such as psychiatric disease,
history of non compliance to medical regimens, or unwillingness to comply with
investigational requirements.

- Participation in another clinical trial in the previous month.

- Less than 2 hours recorded sleep in either arm

Study design
Purpose of the study
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Fisher and Paykel Healthcare

Ethics approval
Ethics application status

Brief summary
This single-blind randomised crossover trial aims to compare the efficacy of a novel
Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an
OSA population, aged over 18.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications