NCT06317077

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Löwenstein Medical Technology GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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%.

Conditions

• Sleep Apnea Syndromes

Interventions

Type	Name	Description
OTHER	PAP therapy setting	Subtherapeutic phases during titration to provoke breathing events after reaching the pressure level with which the breathing events are sufficiently treated
OTHER	exclusive use of Löwenstein Medical full face masks	Use of a Löwenstein Medical full face mask as a requirement for participation in the clinical investigation

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-05-15
• Completion: 2025-05-15
• First posted: 2024-03-19
• Last updated: 2024-03-19

Locations

1 site across 1 country: Germany