Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317077
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-02
Brief Title:
Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
Sponsor:
Löwenstein Medical Technology GmbH Co KG
Organization:
Löwenstein Medical Technology GmbH Co KG
Study Overview
Official Title:
Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EventLAB FF
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None