protocolSection identificationModule nctId: NCT06317077, orgStudyIdInfo id: I5-R1-C-FA, briefTitle: Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks, acronym: EventLAB FF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Löwenstein Medical Technology GmbH & Co. KG, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Sleep Apnea Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: PAP therapy setting, interventions name: exclusive use of Löwenstein Medical full face masks, outcomesModule primaryOutcomes measure: Delta AHI [n/h]= Difference of device AHI (prismaLINE devices of the type WM100TD) and the manual scored AHI of polysomnographic data identified in the Matlab-based SOMNOmat tool, secondaryOutcomes measure: N_AE device [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration, secondaryOutcomes measure: Mask fit score= Leakage, pressure points, stable pressure level, comfort determined via questionnaire, secondaryOutcomes measure: N_AE mask [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration, secondaryOutcomes measure: Delta AI [n/h]= difference of apnea-indices (obstructive/central/mixed) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat, secondaryOutcomes measure: Delta HI [n/h]= difference of hypopnea-indices (obstructive/central) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat, secondaryOutcomes measure: Delta Event_individual [n]= difference of the number (with time, duration, type) of residual breathing events (apneas/hypopneas) device vs. PSG identified in the Matlab-based tool SOMNOmat, secondaryOutcomes measure: N_influenced phases [n]= number (with time, duration, type) of phases with significant deviations between the synchronized device and PSG files identified in the Matlab-based tool SOMNOmat, secondaryOutcomes measure: Delta AHI_1A [n/h]= difference between apnea indices using scoring rule 1A from AASM manual version 3.0, secondaryOutcomes measure: Delta AHI_1B [n/h]= difference between apnea indices using scoring rule 1B from AASM manual version 3.0, secondaryOutcomes measure: Delta AHI_mean [n/h]= difference between apnea indices using mean of scoring rule 1A and 1B from AASM manual version 3.0 (AHI_1A + AHI_1B)/2, secondaryOutcomes measure: Delta AHI_Routine [n/h]= difference between unmachined apnea indices of device and PSG, secondaryOutcomes measure: N_impact factors [n]= number and type of factors that can increase the risk for sleep related breathing disorders like comorbidities and smoking, secondaryOutcomes measure: corr_flow-sleep= correlation between flow signal and sleep state, secondaryOutcomes measure: corr_marker= correlation between diagnostic sleep apnea syndrom markers with medical history data, biomarkers of the diagnostic night, therapy pressure and sleep stage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Krankenhaus Bethanien, city: Solingen, state: NRW, zip: 42699, country: Germany, contacts name: Marc Treml, Dr., role: CONTACT, geoPoint lat: 51.17343, lon: 7.0845, hasResults: False