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Comparison of Two Automatic Positive Airway Pressure Devices in Severe Obstructive Sleep Apnoea

Efficacy and Accuracy of Two Automatic Positive Airway Pressure Brands in PAP-Naïve Patients with Severe Obstructive Sleep Apnoea: A Prospective, Randomized Parallel Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000897369
Enrollment
105
Registered
2026-07-21
Start date
2025-03-10
Completion date
2025-06-13
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study compares two commonly used sleep apnoea treatment devices: the Fisher & Paykel SleepStyle and the ResMed AirSense 10. We want to find out how well each device treats severe obstructive sleep apnoea and how accurately it measures breathing problems during sleep. Participants who are new to positive airway pressure (PAP) treatment will use one of the devices for 4–6 weeks. Information will be collected from overnight oxygen monitoring and questionnaires about sleepiness, treatment use, and satisfaction. The results will help improve sleep apnoea care at Christchurch Sleep Health Services.

Interventions

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 a

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)

Sponsors

Chloe Flinn, Sleep Health Services, Christchurch Hospital, Te Whatu Ora Waitaha Canterbury, Christchurch, New Zealand
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 10, 2026