The study includes a baseline visit, a habituation night, and a therapy night. Both nights will be undertaken in the sleep lab under identical conditions and will include the keepMED PAP therapy activated in parallel to polysomnography (PSG).~Baseline diagnostic PSG, performed within one month prior to enrollment to the study, will be used to assess the device efficacy.~An interim analysis to re-estimate the sample size will be performed after availability of data of 50% enrolled and treated study patients. The sample size will be re-estimated based on the observed changes of AHI in the interim analysis.
A prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device.~The primary study objective is to assess the efficacy of the keepMED PAP device on modification of respiratory characteristics in patients with OSA at one therapy night in a sleep lab.~Secondarily, the safety of the use of the device in this setting is assessed.