None listed
Conditions
Brief summary
This study will trial a new personalised support program to help individuals diagnosed with obstructive sleep apnoea (OSA) improve adherence to their treatment. Despite the major impact OSA has on health and wellbeing, the current front-line treatment for OSA (continuous positive airway pressure; CPAP) is poorly tolerated. Co-designed with patients, this study will combine continuous monitoring and tailored support to better manage symptoms, troubleshoot treatment problems, and improve quality of life. We hypothesise that this program (SAMMA) will improve residual OSA severity, measured via the apnoea-hypopnea index (AHI), as well as health related quality of life, therapy use, and other OSA-related symptoms. This study will use a randomised controlled trial design, as well as health economics, to compare usual care to our tailored support program.
Interventions
Participants in the support arm will receive a multi-component support program in addition to standard CPAP care. The program comprises feedback about their measured sleep and breathing, educational and motivational materials, and access to trained support personnel, primarily delivered through the CareMappr app. The specific components have been and will continue to be developed in partnership with our consumer team, some of whom contributed to the initial conception of this work. The frequency of in-app prompts and the type of supports delivered will be flexible, enabling personalised support for each participant in the intervention arm. Sleep and breathing data captured by the Withings under-mattress sensor will be transferred automatically to the CareMappr app via an established API integration between the two platforms; no manual data entry by participants or study staff is required. Participants will also be asked to complete brief in-app check-ins (daily for the first 14 days, then at a frequency selected by the individual) which provide self-reported data on CPAP use, symptoms, and sleep. Educational materials presented within the app will include short-form videos co-developed with consumers and sleep clinicians, and written explainers and infographics covering topics such as CPAP mask fit, sleep hygiene, and managing common side effects. These will link to further information provided by partnering not-for-profit organisations (Australasian Sleep Association, Sleep Disorders Australia, Sleep Health Foundation). Motivational materials will include peer-experience video content, prompted and passive progress feedback drawn from the participant's own sleep data, and push notifications timed to support engagement at clinically relevant points (e.g., the first two weeks of therapy initiation). Participants will be able to contact trained support personnel through an in-app embedded booking system. The support personnel are members of the study team (not CareMappr employees) with backgrounds in sleep health and CPAP support, who have also completed a bespoke, formal CPAP coaching program delivered remotely by inHealth Medical Services (California). Their role is to: troubleshoot device and app issues; respond to participant questions about therapy; provide brief, structured support drawn from the program's content modules; and identify and refer participants to their treating clinician or other appropriate services where clinical concerns are raised. Support personnel do not provide medical advice or alter prescribed therapy. Usage or adherence of the intervention will be monitored using CareMappr app analytics, including frequency of app logins, time spent in educational content, completion of check-ins, and push notification delivery, open, and action rates. CPAP use will be captured separately via the device's standard data download. Where alternate treatments are initiated, adherence data will be collected via patient report in follow-up surveys and via clinical notes captured at follow-up clinical appointments. These metrics support program responsiveness for individual participants and will inform process evaluation but are not themselves trial outcomes. Participants in both arms will continue with their usual clinical care, independent of the study intervention. This refers to ongoing management of OSA and any comorbid conditions by the participant's treating sleep physician, GP, and other clinicians as relevant, including attendance at scheduled appointments, prescribed CPAP follow-up, and any other directed management (e.g., weight management, positional therapy). The study does not alter or replace any element of routine clinical care. During the 12-month monitoring period, participants in both arms will be given the Withings under-mattress sensor to monitor sleep and breathing, which will inform the primary outcome. All participants will also be offered optional access to the Hoap app - a smartphone-based daily check-in tool that records self-reported details about sleep timing and quality, mood, and daytime symptoms such as fatigue - as well as an finger-worn oximeter or a sleep tracking ring. These additional measurement tools are not part of the support program intervention. Participants will complete follow-up surveys remotely via REDCap at 3, 6, 9, and 12 months.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adult aged 18 years or over 2. Positive diagnosis of OSA by their treating physician 3. CPAP indicated as first-line treatment by treating physician
Exclusion criteria
1. Inability or unwillingness to provide informed consent 2. Unwillingness to undergo CPAP treatment for their OSA