Evaluating the Benefit of Home Support Provider Services for Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for an Ambispective International Real-World Study.

Abstract

Background: Adherence and persistence to positive airway pressure (PAP) therapy are key factors for positive health outcomes. Home support providers participate in the home implementation and follow-up of PAP therapy for patients with obstructive sleep apnea (OSA). In Europe, home support provider service levels are country (or area) specific, resulting in differences in content and frequency of patient interactions. However, no robust evaluation of the impact of these differences on clinical and patient outcomes has been performed.

Objective: The AWAIR study aims to evaluate and compare the impact of different home support provider service levels on PAP adherence and persistence in 4 European countries.

Methods: This real-world, ambispective, cohort study-conducted in France, Belgium, Spain, and Portugal-will recruit adults with OSA who started PAP therapy between 2019 and 2023 and were followed by an Air Liquide Healthcare home support provider. Given the large number of eligible participants (around 150,000), the study will use a decentralized and digital approach. A patient video will present the study objectives and the participation process. A secure electronic solution will be used to manage patient information and consent, as well as to administer a web-based questionnaire. Retrospective data, collected during routine patient follow-up by home support providers, include the level of service and device data, notably PAP use. Prospective data collected using an electronic patient-reported outcome tool include health status, OSA-related factors, patient-reported outcomes including quality of life and symptoms, OSA and PAP literacy, patient-reported experience, and satisfaction with PAP therapy and service. Hierarchical models, adjusted for preidentified confounding factors, will be used to assess the net effect of home support provider services on PAP adherence and persistence while minimizing real-world study biases and considering the influence of country-level contextual factors. We hypothesize that higher levels of home support provider services will be positively associated with adherence and persistence to PAP therapy.

Results: As of December 2024, the study has received approval in France, Portugal, and 2 regions of Spain. The study began enrollment in France in October 2024. Results are expected in the second quarter of 2025.

Conclusions: The AWAIR study has a unique design, leveraging an unprecedented number of eligible participants, decentralized technologies, and a real-world comparative methodology across multiple countries. This approach will highlight intercountry differences in terms of patient characteristics, PAP adherence, and persistence, as well as patient-reported outcomes, patient-reported experiences, and satisfaction with the home service provider. By assessing the added value of home support provider services, the results will support best practices for patient management and for decision-making by payers and authorities.

International registered report identifier (irrid): PRR1-10.2196/65840.