Work package 8: Prospective ESADA study

Lead: Gothenburg University

This work package will validate the new diagnostic and therapeutic algorithms developed in the Sleep Revolution project so far. A prospective study will include 1000 patients in the European Sleep Apnea Database network of 24 sleep centers across Europe. To start we need a finalized clinical study protocol and an approval from the ethical review board in all centers of the ESADA. Thereafter 1000 patients will be randomized to standard care according to the different routines in the ESADA centers or the new diagnostic pathways of the “Sleep Revolution” Project. 

This new pathway is defined by home polysomnography over several nights managed by the patients, self-assessment by App-based communication systems and the novel, semi-automated data analysis of the sleep recordings using artificial intelligence analysis tools. After diagnosis, a significant proportion of patients will receive a sleep apnea diagnosis and CPAP treatment will be started in the subgroup of patients with more pronounced disease. Again, 50% of patients will follow the standard procedure for long-term management of CPAP treatment. 

The second half od patients will follow the novel principle developed in the “Sleep Revolution” project: Self applied polysomnography at home over 3 nights, automated sleep analysis by means of artificial intelligence algorithms, patient self-reported symptom report and CPAP treatment data export via telemedicine. 

Outcomes on diagnosis and treatment success will be compared between traditional clinical routines used in Europe today versus the novel “Sleep Revolution” procedure. The aim of the study is to show the potential advantages and disadvantages of the new methodologies to be developed in the program. The study will also provide new insights on where to optimize those new tools, pathways and algorithms of the “Sleep Revolution” project. The unique study design involving 24 sleep centers within the ESADA network across Europe will provide a possibility to disseminate the new ideas over entire Europe but also to test the concept in very different clinical conditions.

Participants: