Clinical trial NCT06317077: Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
Official title: Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Apnea Syndromes
Keywords: sleep-related breathing disorders
obstructive sleep apnea
event classification
device
full face mask
apnea-hypopnea-index
polysomnography
accuracy
Lead sponsor: Löwenstein Medical Technology GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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%.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 1 night
Secondary outcomes:
measure: N_AE device [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration
timeFrame: 1 night
measure: Mask fit score= Leakage, pressure points, stable pressure level, comfort determined via questionnaire
timeFrame: 1 night
measure: N_AE mask [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration
timeFrame: 1 night
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
timeFrame: 1 night
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
timeFrame: 1 night
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
timeFrame: 1 night
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
timeFrame: 1 night
measure: Delta AHI_1A [n/h]= difference between apnea indices using scoring rule 1A from AASM manual version 3.0
timeFrame: 1 night
measure: Delta AHI_1B [n/h]= difference between apnea indices using scoring rule 1B from AASM manual version 3.0
timeFrame: 1 night
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
timeFrame: 1 night
measure: Delta AHI_Routine [n/h]= difference between unmachined apnea indices of device and PSG
timeFrame: 1 night
measure: N_impact factors [n]= number and type of factors that can increase the risk for sleep related breathing disorders like comorbidities and smoking
timeFrame: 1 night
measure: corr_flow-sleep= correlation between flow signal and sleep state
timeFrame: 1 night
measure: corr_marker= correlation between diagnostic sleep apnea syndrom markers with medical history data, biomarkers of the diagnostic night, therapy pressure and sleep stage
timeFrame: 1 night
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Krankenhaus Bethanien
state: NRW
Study officials:
affiliation: Krankenhaus Bethanien (Solingen), Klinik für Pneumologie und Allergologie/Zentrum für Schlaf- und Beatmungsmedizin
name: Winfried Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: