SLEEP WELL

Abstract

BackgroundThe standard treatment of obstructive sleep apnea (OSA) is nocturnal positive airway pressure (PAP) therapy, which only has positive effects on symptoms and sequelae with regular and long-term use. Interface problems in existing care lead to incorrect treatment and long waiting times in the diagnostics and therapy, which are aggravated by the pandemic.ObjectiveBased on the existing structures a cross-sectoral care treatment model for the diagnostics and therapy of OSA will be evaluated. The central goals are a timely, needs-oriented care with optimized quality and efficiency. Furthermore, treatment adherence and thus quality of life should be improved as well as the cross-sectoral collaboration. The SLEEP WELL project is funded by the G-BA Innovation Fund (funding reference 01NVF20020).Material and methodsThe evaluation will be carried out based on a prospective, randomized, controlled, multicenter study in North Rhine-Westphalia, Germany, in which 4448 patients with suspected OSA receive guideline-compliant care with telemedicine (telemedicine group) or without telemedicine (control group). The 1:1 randomization takes place after initial suspicion by the primary physician. The two groups are compared in terms of quality of life (primary endpoint), PAP therapy adherence, and medical resource use (secondary outcomes).Results and discussionQuantitative data collation occurs at 5 time points. In an intention to treat analysis the results are analyzed using statistical evaluation methods. Patient and provider satisfaction will be assessed using qualitative methods. The cost-benefit relation is examined on the basis of routine health insurance data. In addition, remuneration concepts for standard care will be developed. Project completion is planned for September 2025.