Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography… (NCT06317077) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
Germany49 participantsStarted 2024-12-02
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Trial details
NCT IDNCT06317077
SponsorLöwenstein Medical Technology GmbH & Co. KG