Reliability of respiratory event detection with continuous positive airway pressure in moderate to severe obstructive sleep apnea - comparison of polysomnography with a device-based analysis.

"Declarations Ethical approvalThis study was approved by the ethics committee of Witten/Herdecke University under number 192/2018 and was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. All persons gave their informed consent prior to their inclusion in the study. Conflict of interestM Richter, M Schroeder, and U Domanski have no financial or other potential conflicts of interest associated with this study. M Schwaibold is employee of Loewenstein Medical Technology. G Nilius has received research support from Loewenstein Medical Technology, Fisher & Paykel Healthcare, ResMed and Weinmann; this has gone into department funds. Conflict of interest M Richter, M Schroeder, and U Domanski have no financial or other potential conflicts of interest associated with this study. M Schwaibold is employee of Loewenstein Medical Technology. G Nilius has received research support from Loewenstein Medical Technology, Fisher & Paykel Healthcare, ResMed and Weinmann; this has gone into department funds."

"Funding Loewenstein Medical Technology provided financial support for the study. This has gone into departments funds. The sponsor had no role in the design or conduct of this research."

"Inclusion criteria were age ≥ 18, moderate to severe sleep apnea syndrome (defined as AHI ≥ 15 n/h), recently diagnosed by PSG, indication for CPAP therapy, and use of a nasal mask. Exclusion criteria: CPAP contraindication, participation in another study that influences the setting of CPAP therapy by specifications regarding device setting or deviating titration needs. Patients needing an oronasal mask (OM) were excluded to ensure comparability. An acceptable study was one with a recorded TST > 4 h and < 10% of excessive leakage. During critically high leakage, there is a limited device response and possibly therapy ineffectiveness. From a leakage value of ≥ 50 L per minute, the “High leakage” event is recorded in the therapy device. The Ethics Committee of Witten-Herdecke University, Germany approved the study under number 192/2018. The trial was retrospectively registered under ClinicalTrials.gov Identifier: NCT04407949. Preliminary results were previously presented at the European Respiratory Society Congress in 2020 []. All patients provided consent to participate in the study after oral and written information about the study. Anthropometric baseline data were recorded at hospital admission. The cardiorespiratory PSG nights were performed in the certified sleep laboratory under the supervision of a sleep technician. The study-relevant therapy night with CPAP therapy under PSG took place immediately after the diagnosis night. The pressure titration procedure was predetermined for the study (see Fig. ). Pressure started at 4 cm H2O, a sub therapeutic phase that allowed more residual events, and was increased every hour after sleep onset up to a pressure of 13 cm H2O, when sleep duration allowed this procedure.Fig. 1Study flow chart Conclusion: The device-based analysis showed a high correlation in the determination of residual obstructive AHI under therapy. The recorded residual respiratory event indices in combination with the data about leakage and adherence of the studied device provide reliable information for the implementation and follow-up of CPAP therapy in a typical group of patients with OSA.: Trial Registration Number: ClinicalTrials.gov Identifier: NCT04407949, May 29, 2020, retrospectively registered."