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

INTERVENTION: 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 CONDITION: Obstructive Sleep Apnoea; ; Obstructive Sleep Apnoea Respiratory ‐ Sleep apnoea PRIMARY OUTCOME: Oximetry‐derived oxygen desaturation index (ODI)[Bitmos Sat 801+ (Bitmos GmbH, Dusseldorf, Germany), using the 3% desaturation rule to score events related to sleep apnoea 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.] 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) SECONDARY OUTCOME: Daytime sleepiness[Epworth Sleep Scale (ESS) 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.] Delivered pressures: maximum pressures[InfoSmart and Airview reports showing maximum pressures (cmH2O) delivered by the device 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.] Delivered pressures: median pressures[InfoSmart and Airview reports showing median pressures (cmH2O) delivered by the device 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.] Device reported apnoea/hypopnoea inde X(AHI)[Fisher & Paykel SleepStyle InfoSmart report and ResMed AirView report. The AHI will be assessed as a composite outcome. 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.] Nocturnal hypoxaemia burden (T90)[Bitmos Sat 801+ (Bitmos GmbH, Dusseldorf, Germany); percentage of time oxygen saturation spent under 90% 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.] Patient satisfaction[Visual analogue scale: 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?" The VAS is administered once during the 4‐6‐week in person review] Treatment adherence[InfoSmart and AirView device reports assessing usage hours (reported in total minutes) and days (as a percentage of days used/total days) 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.]