NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Löwenstein Medical Technology GmbH & Co. KG
Conditions: Sleep Apnea Syndromes
Interventions: PAP therapy setting, exclusive use of Löwenstein Medical full face masks
Countries: Germany
Sleep-related breathing disorders are highly prevalent and are usually treated with positive airway pressure (PAP) therapy. To determine the quality of therapy, PAP therapy devices measure the frequency of residual breathing events. For this purpose, breathing events of different classes are detected, counted and identified. This clinical investigation aims to evaluate the performance of prismaLINE devices based on the accuracy of the apnea-hypopnea index (AHI) recorded in the devices. During the PAP titration night, the AHI is similarly detected via polysomnography (PSG) device and a subsequent manual scoring of the recorded PSG data. The validation of the device AHI accuracy refers to the alignment with the manually scored AHI. Further goals of this clinical investigation are the confirmation of safety of the prismaLINE devices, the confirmation of performance and safety of LM full face masks (full face masks of the manufacturer Löwenstein Medical Technology), as well as the investigation of the influence of LM full face masks on therapy quality. The most relevant inclusion criteria are diagnosis of a sleep-related breathing disorder and indication for therapy with continuous positive airway pressure (CPAP). Treatment takes place with prismaLINE PAP therapy devices in combination with LM full face masks.
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Solingen, North Rhine-Westphalia, Germany