Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000897369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
30/06/2026
Date registered
Help: Date registered
21/07/2026
Date last updated
Help: Date last updated
21/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
21/07/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Two Automatic Positive Airway Pressure Devices in Severe Obstructive Sleep Apnoea
Scientific title
Efficacy and Accuracy of Two Automatic Positive Airway Pressure Brands in PAP-Naïve Patients with Severe Obstructive Sleep Apnoea: A Prospective, Randomized Parallel Study
Additional trial identifiers [1] 317741 0
ERG 24209
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Obstructive Sleep Apnoea 342637 0
Condition category
Condition code
Respiratory 338781 338781 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
In accordance with the Christchurch Sleep Health Services protocol and usual practice, participants will engage in a trial of Postive Airway Pressure (PAP) therapy using the ResMed AirSense 10 Automatic Positive Airway Pressure (APAP) device.This involves a 4 - 6-week initiation period for patients to be established on PAP therapy. The study period will be divided into the following phases:

Initial Setup (Day 1): As with standard care, participants will attend a 2-hour group setup appointment at Christchurch Hospital, where they will be educated on obstructive sleep apnoea (OSA), PAP therapy, and device maintenance for the AirSense S10. They will be fitted with an appropriate mask (nasal pillows, nasal, or full face) based on individual needs and preferences. Participants will be advised of adherence requirements for publicly funded treatment which is for the device to be used for a minimum of 5 hours/night, 5 days/week. Adherence is monitored remotely through AirView and is accessed during reviews, as well as when patients contact the Sleep Service with questions or concerns.

7-day telephone review (Week 1): Participants will receive a scheduled phone call 7 days (±2 days) after the initial set-up. Research staff carrying out the phone call will access the AirView report during the review to assess adherence and treatment efficacy. All queries and concerns will be addressed at this time to promote adherence. Pressure adjustments may be made if device-reported AHI averages more than 5 events/hour (excluding central events). Participants requiring in person assistance, such as a mask fit will be scheduled within 5 days.

End of trial period (weeks 4 – 6): Participants will come in to the Christchurch Sleep Health Services around week 5 (±1 week) for final review. Research staff carrying out the review will access the AirView reports to assess adherence and treatment efficacy. The Epworth Sleepiness Scale (ESS) and a Visual Analogue Scale (VAS) will be administered. The VAS will consist of a 100 mm line ranging from “Not at all satisfied” to “Completely satisfied” in order to answer the question: "Considering the comfort of the device, improvement of your sleep apnoea symptoms, and overall ease of use, how satisfied are you with this APAP device?". As with standard practice, overnight oximetry on therapy will be conducted. The end-of-trial period is defined by the last day, occurring after one night of successful oximetry on therapy; 4-to-6 weeks post set-up, or extended if oximetry fails the first time.

As with standard practice at the end of the trial period, participants who want to continue with long-term treatment, will continue their care through the Sleep Health Services; this will be noted for the purposes of the study.

The initial set-up is carried out by one or two Clinical Physiologists in a group setting of up to eight patients. The one-week phone call is conducted by a Clinical Physiologist. The last visit which is scheduled for 30-minutes at Christchurch Hospital is carried out one-on-one with a Clinical Physiologist.

The Clinical Physiologists carrying out these appointments are involved in the research aspect and trained on the protocol, they include Chloe Flinn (Clinical Physiologist, Christchurch Hospital), Lise du Toit (Clinical Physiologist, Christchurch Hospital) and Brooke Carroll (Clinical Physiologist, Christchurch Hospital)
Intervention code [1] 334578 0
Treatment: Devices
Description of the comparator or control
In accordance with the Christchurch Sleep Health Services protocol and usual practice, participants will engage in a trial of PAP therapy using the Fisher & Paykel Healthcare SleepStyle APAP device. This involves a 4 - 6-week initiation period for patients to be established on PAP therapy. The study period will be divided into the following phases:

Initial Setup (Day 1): As with standard care, participants will attend a 2-hour group setup appointment at Christchurch Hospital, where they will be educated on OSA, PAP therapy, and device maintenance for the SleepStyle. They will be fitted with an appropriate mask (nasal pillows, nasal, or full face) based on individual needs and preferences. Participants will be advised of adherence requirements for publicly funded treatment which is for the device to be used for a minimum of 5 hours/night, 5 days/week. Adherence is monitored remotely through InfoSmart and is accessed during reviews, as well as when patients contact the Sleep Service with questions or concerns.

7-day telephone review (Week 1): Participants will receive a scheduled phone call 7 days (±2 days) after the initial set-up. Research staff carrying out the phone call will access the SleepStyle report during the review to assess adherence and treatment efficacy. All queries and concerns will be addressed at this time to promote adherence. Pressure adjustments may be made if device-reported AHI averages more than 5 events/hour (excluding central events). Participants requiring in person assistance, such as a mask fit will be scheduled within 5 days.

End of trial period (weeks 4 – 6): Participants will come in to the Christchurch Sleep Health Services around week 5 (±1 week) for final review. Research staff carrying out the review will access the SleepStyle report to assess adherence and treatment efficacy. The Epworth Sleepiness Scale (ESS) and a Visual Analogue Scale (VAS) will be administered. The VAS will consist of a 100 mm line ranging from “Not at all satisfied” to “Completely satisfied” in order to answer the question: "Considering the comfort of the device, improvement of your sleep apnoea symptoms, and overall ease of use, how satisfied are you with this APAP device?". As with standard practice, overnight oximetry on therapy will be conducted. The end-of-trial period is defined by the last day, occurring after one night of successful oximetry on therapy; 4-to-6 weeks post set-up, or extended if oximetry fails the first time.

As with standard practice at the end of the trial period, participants who want to continue with long-term treatment, will continue their care through the Sleep Health Services; this will be noted for the purposes of the study.

The initial set-up is carried out by one or two Clinical Physiologists in a group setting of up to eight patients. The one-week phone call is conducted by a Clinical Physiologist. The last visit which is scheduled for 30-minutes at Christchurch Hospital is carried out one-on-one with a Clinical Physiologist.

The Clinical Physiologists carrying out these appointments are involved in the research aspect and trained on the protocol, they include Chloe Flinn (Clinical Physiologist, Christchurch Hospital), Lise du Toit (Clinical Physiologist, Christchurch Hospital) and Brooke Carroll (Clinical Physiologist, Christchurch Hospital)
Control group
Active

Outcomes
Primary outcome [1] 345978 0
Oximetry-derived oxygen desaturation index (ODI)
Timepoint [1] 345978 0
Diagnostic (baseline) and one night at the end of trial period. The end-of-trial period is defined by the last day, occurring after one night of successful oximetry on therapy. Oximetry is carried out the night of the final review (4-6 weeks post initial set-up), but the time period may be extended if oximetry fails on the first attempt. Oximetry is repeated if signal quality is poor or if PAP therapy is not used in conjunction with the oximeter.
Secondary outcome [1] 463995 0
Device reported apnoea/hypopnoea index (AHI)
Timepoint [1] 463995 0
On the same night as successful oximetry; end of trial period: defined by the last day, occurring after one night of successful oximetry on therapy. Oximetry is carried out the night of the final review (4-6 weeks post initial set-up), but the time period may be extended if oximetry fails on the first attempt. Oximetry is repeated if signal quality is poor or if PAP therapy is not used in conjunction with the oximeter.
Secondary outcome [2] 463997 0
Daytime sleepiness
Timepoint [2] 463997 0
Diagnostic (baseline) and end of trial period: defined by the last day, occurring after one night of successful oximetry on therapy. Oximetry is carried out the night of the final review (4-6 weeks post initial set-up), but the time period may be extended if oximetry fails on the first attempt. Oximetry is repeated if signal quality is poor or if PAP therapy is not used in conjunction with the oximeter.
Secondary outcome [3] 463998 0
Nocturnal hypoxaemia burden (T90)
Timepoint [3] 463998 0
Diagnostic (baseline) and one night at the end of trial period: defined by the last day, occurring after one night of successful oximetry on therapy. Oximetry is carried out the night of the final review (4-6 weeks post initial set-up), but the time period may be extended if oximetry fails on the first attempt. Oximetry is repeated if signal quality is poor or if PAP therapy is not used in conjunction with the oximeter.
Secondary outcome [4] 463999 0
Treatment adherence
Timepoint [4] 463999 0
From the start of the trial period (day 1) to the end of trial period: defined by the last day, occurring after one night of successful oximetry on therapy. Oximetry is carried out the night of the final review (4-6 weeks post initial set-up), but the time period may be extended if oximetry fails on the first attempt. Oximetry is repeated if signal quality is poor or if PAP therapy is not used in conjunction with the oximeter.
Secondary outcome [5] 464000 0
Delivered pressures: median pressures
Timepoint [5] 464000 0
From the start of the trial period (day 1) to the end of trial period: defined by the last day, occurring after one night of successful oximetry on therapy. Oximetry is carried out the night of the final review (4-6 weeks post initial set-up), but the time period may be extended if oximetry fails on the first attempt. Oximetry is repeated if signal quality is poor or if PAP therapy is not used in conjunction with the oximeter.
Secondary outcome [6] 464001 0
Patient satisfaction
Timepoint [6] 464001 0
The VAS is administered once during the 4-6-week in person review
Secondary outcome [7] 464958 0
Delivered pressures: maximum pressures
Timepoint [7] 464958 0
From the start of the trial period (day 1) to the end of trial period: defined by the last day, occurring after one night of successful oximetry on therapy. Oximetry is carried out the night of the final review (4-6 weeks post initial set-up), but the time period may be extended if oximetry fails on the first attempt. Oximetry is repeated if signal quality is poor or if PAP therapy is not used in conjunction with the oximeter.

Eligibility
Key inclusion criteria
1. Greater than or equal to 18 years old, with the ability to provide independent informed consent
2. Diagnosed with severe OSA (ODI greater than 30 events/hour)
3. PAP therapy naïve
4. Considered as suitable for a group PAP set-up appointment as determined by the sleep multidisciplinary team (MDT)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Patients who are being considered for non-invasive ventilation (NIV) treatment. Determined by the Sleep MDT and usually involves patients with periods of hypoventilation and/or significant desaturation

Unwilling or unable to participate in a group setup appointment

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)
Central randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to randomization, participants will be stratified according to baseline ODI: one group includes those with an ODI of 30–50 events per hour, while the other consists of those with an ODI greater than 50. Participants are then randomized in a 1:1 ratio to either the AirSense 10 or SleepStyle device, using a stratified allocation protocol managed by an independent researcher not involved in participant care or assessment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Randomisation was incorporated into this prospective observational study to ensure balanced allocation of participants to either the Fisher & Paykel or ResMed device. Existing clinical practice tended to favour ResMed device allocation, which could have resulted in a substantially uneven distribution between groups. The randomisation process was therefore used to minimise allocation bias, maintain balance between device cohorts, and support achievement of the planned sample size.

Sample size: A sample size of n=50 in each randomised group (n=110 in total to account for dropouts) will enable effect sizes > 0.6 to be detected as statistically significant (two-tailed a=0.05) with 80% power. This equates to a difference in the AHI and ODI changes of approximately 5 and 6 events per hour respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/03/2025
Date of last participant enrolment
Anticipated
Actual
13/06/2025
Date of last data collection
Anticipated
Actual
25/07/2025
Sample size
Target
110
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 28265 0
New Zealand
State/province [1] 28265 0
Canterbury

Funding & Sponsors
Funding source category [1] 322283 0
Other Collaborative groups
Name [1] 322283 0
Canterbury Medical Research Foundation (CMRF)
Country [1] 322283 0
New Zealand
Funding source category [2] 322285 0
Hospital
Name [2] 322285 0
Te Whatu Ora - as participants qualify for publicly-funded treatment
Country [2] 322285 0
New Zealand
Primary sponsor type
Individual
Name
Chloe Flinn, Sleep Health Services, Christchurch Hospital, Te Whatu Ora Waitaha Canterbury, Christchurch, New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 325197 0
None
Name [1] 325197 0
Address [1] 325197 0
Country [1] 325197 0
Other collaborator category [1] 284009 0
Individual
Name [1] 284009 0
Paul Kelly, Sleep Health Services, Christchurch Hospital, Te Whatu Ora Waitaha Canterbury, Christchurch, New Zealand
Address [1] 284009 0
Country [1] 284009 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320799 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 320799 0
Ethics committee country [1] 320799 0
New Zealand
Date submitted for ethics approval [1] 320799 0
02/12/2024
Approval date [1] 320799 0
22/01/2025
Ethics approval number [1] 320799 0
2025 EXP 21924

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

Contacts
Principal investigator
Name 151670 0
Miss Chloe Flinn
Address 151670 0
Christchurch Hospital, 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710
Country 151670 0
New Zealand
Phone 151670 0
+64 364 1089
Fax 151670 0
Email 151670 0
[email protected]
Contact person for public queries
Name 151671 0
Chloe Flinn
Address 151671 0
Christchurch Hospital, 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710
Country 151671 0
New Zealand
Phone 151671 0
+64 364 1089
Fax 151671 0
Email 151671 0
[email protected]
Contact person for scientific queries
Name 151672 0
Chloe Flinn
Address 151672 0
Christchurch Hospital, 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710
Country 151672 0
New Zealand
Phone 151672 0
+64 364 1089
Fax 151672 0
Email 151672 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Research Proposal.pdf
Ethical approval    HDEC_Approval_Letter.pdf
Informed consent form    PIS ICF_v2.pdf
Other    Locality Approval HNZC_Locality_App_Form_signed.pdf


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.