Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks

Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks

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.

The duration of the clinical investigation per participant is two or three nights: diagnosis night with the following CPAP titration night. A further titration night (CPAP or APAP) might be necessary to find optimal therapy settings. But only the CPAP titration night with the best therapy result will be analysed.

The titration night is performed according to a predefined titration scheme. Therapy pressure will be gradually increased until breathing events are treated sufficiently. Due to the need of a certain number of remaining breathing events for sufficient performance evaluation, therapy pressure will be gradually reduced after reaching the ideal pressure level to provoke additional breathing events. The titration night is additionally monitored and recorded via polysomnography (PSG). No significant negative impact on patients' condition based on subtherapeutic phase is expected.

After the end of the clinical investigation participants will be treated according to clinical routine.

The performance of the prismaLINE therapy device will be evaluated by the accuracy of the alignment between the device AHI and the manually scored PSG AHI (using AASM hypopnea scoring rule 1A). The alignment between device AHI versus PSG AHI will be defined for coincident titration night recordings of both, therapy and PSG device.

The accuracy of the device AHI is defined by the absolute or relative deviation from the manually scored PSG AHI (ΔAHI_rel or ΔAHI_abs) and classified in acceptable, good, very good or unacceptable. The maximum deviation (ΔAHI_rel or ΔAHI_abs) is used throughout to determine the corresponding device AHI values for each category.

To achieve the primary endpoint, the proportion of the investigation population with an at least acceptable device AHI must be ≥ 80%.

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