Clinical Research Directory

Inclusion Criteria: * Polysomnographic diagnosis performed at the investigator site * Indication for CPAP therapy (initial setting) * Age of the participants: ≥ 18 ≤ 80 years * AHI diagnosis night ≥ 15/h * Capacity to consent * Agreement to use a full face mask of Löwenstein Medical during the titration night * Existence of a signed informed consent form for participation in the clinical investigation and a signed declaration of consent for the use of data within the scope of the DSGVO Exclusion Criteria: * Presence of a contraindication to CPAP therapy * Participation in another clinical investigation that influences the adjustment to CPAP therapy by stipulate device settings or titration * pregnant or breastfeeding woman Inclusion Criteria Statistical Evaluation: * AHI PSG (diagnosis and therapy) and AHI of the device (therapy) are completely available * Evaluation of the mask/device functionalities is available * Clear documentation of (predictable) adverse events and (predictable) adverse device effects * Existence of a signed informed consent form for participation in the clinical investigation and a signed declaration of consent for the use of data within the scope of the DSGVO * Reliable evaluation of the polysomnography (titration night) is possible: no missing signals, good signal quality, no deviation of the applied CPAP pressure course from the course specified for the clinical investigation * Total sleep time during the titration night ≥ 4 hrs * Proportion of the therapy time with high leakage (more than 50 l/min) \< 10% * The quality assurance process did not identify any deviations from the source data that could not be corrected