Evaluation of a cross-sectoral care model including novel telemedical concepts for diagnosis and treatment of obstructive sleep apnea (SLEEP WELL)

Abstract Background Obstructive sleep apnea (OSA) is the most common organic sleep disorder. Nocturnal positive airway pressure (PAP) therapy is the first-line treatment, although positive effects can only be expected with regular and long-term use. In view of the increasing OSA prevalence, interface problems in existing care are becoming apparent, leading to inadequate care and long waiting times for diagnosis and treatment. This also has an impact on treatment adherence and support. Hypothesis A telemedically supported patient pathway leads to timely diagnosis and needs-based initiation of treatment and improves adherence. This leads to an improved quality of life. Patients and methods In a prospective randomized controlled multicenter study, patients with clinically suspected OSA are treated according to guidelines with or without the help of telemedicine (telemedicine and control groups). A total of n = 4448 patients will be included. After guideline-compliant diagnosis and treatment initiation, patients will be followed for up to 12 months, whereby patients in the telemedicine group receive additional telemedical sleep medicine support. For n = 371 patients in the telemedicine group, it will also be investigated whether home-based telemedically supported initiation of PAP therapy under polygraphic control is expedient in the case of a high clinical pre-test probability, clear diagnostic polygraphy findings, and a low comorbidity burden. The new care services will be reimbursed to the participating medical service providers using project funds. In addition to a clinical evaluation, a health economic analysis of secondary data from patients of the participating health insurance funds (TKK, BARMER, DAK, and IKK classic) will be carried out. Primary outcome is sleepiness-related quality of life measured with the standardized functional outcomes of sleep questionnaire (FOSQ). Secondary endpoints are patient-reported outcomes (daytime sleepiness, treatment satisfaction), number of guideline-compliant treatments, PAP therapy adherence, and cost effectiveness and cost utility of the new forms of care. The satisfaction of the medical service providers will also be evaluated. Results The results of the study are expected at the end of the third quarter of 2025. Registration of the study DRKS00027895