Sleep Apnea SyndromesEventLAB FFNCT06317077
Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
A study testing PAP therapy setting and exclusive use of Löwenstein Medical full face masks in people with Sleep Apnea Syndromes, run by Löwenstein Medical Technology GmbH & Co. KG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- PAP therapy setting and exclusive use of Löwenstein Medical full face masks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- 2 Dec 2024to 17 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- PAP therapy setting, exclusive use of Löwenstein Medical full face masks
- Keywords
- sleep-related breathing disorders, obstructive sleep apnea, event classification, device, full face mask, apnea-hypopnea-index, polysomnography, accuracy
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAP therapy settingOther
Subtherapeutic phases during titration to provoke breathing events after reaching the pressure level with which the breathing events are sufficiently treated
exclusive use of Löwenstein Medical full face masksOther
Use of a Löwenstein Medical full face mask as a requirement for participation in the clinical investigation
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | All participants of the clinical investigation undergo the standard stages of the clinical routine within an initial PAP therapy setting: a diagnostic night followed by a titration night (or if necessary two titration nights) with prescribed titration scheme. All participants use a full face mask of Löwenstein Medical. Receives: Other: PAP therapy setting; Other: exclusive use of Löwenstein Medical full face masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
comparison of PSG AHI (according to AASM hypopnea scoring rule 1A and 1B) and device AHI for the period in which the records of both devices are available
Measured: 1 night
Secondary outcomes (14)
N_AE device [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration
Confirmation of safety of the prisma therapy devices (type WM100TD)
Measured: 1 night
Mask fit score= Leakage, pressure points, stable pressure level, comfort determined via questionnaire
Confirmation of performance of the full face masks of Löwenstein Medical
Measured: 1 night
N_AE mask [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration
Confirmation of safety of the full face masks of Löwenstein Medical
Measured: 1 night
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
Investigation of the accordance of the individual event indices of the synchronized device and PSG files
Measured: 1 night
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
Investigation of the accordance of the individual event indices of the synchronized device and PSG files
Measured: 1 night
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
Comparison of all AHI-relevant individual events of the synchronized device and PSG files
Measured: 1 night
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
investigation of influencing factors for accordance between therapy device and the polysomnography (e.g. phases with increased pressure or increased leakage)
Measured: 1 night
Delta AHI_1A [n/h]= difference between apnea indices using scoring rule 1A from AASM manual version 3.0
investigation of impact of AASM hypopnea scoring rules 1A from AASM manual, version 3.0
Measured: 1 night
Delta AHI_1B [n/h]= difference between apnea indices using scoring rule 1B from AASM manual version 3.0
investigation of impact of AASM hypopnea scoring rules 1B from AASM manual, version 3.0
Measured: 1 night
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
investigation of impact of AASM hypopnea mean of scoring rule 1A and 1B from AASM manual, version 3.0
Measured: 1 night
Delta AHI_Routine [n/h]= difference between unmachined apnea indices of device and PSG
comparison of original device AHI and PSG AHI to investigate the alignment of routine device AHI with routine PSG AHI (1A/1B)
Measured: 1 night
N_impact factors [n]= number and type of factors that can increase the risk for sleep related breathing disorders like comorbidities and smoking
investigation of influencing factors and identification of confounders
Measured: 1 night
corr_flow-sleep= correlation between flow signal and sleep state
identification of correlation between flow signal and sleep state
Measured: 1 night
calc_marker = possible correlations of calculated sleep apnea syndrome markers (e. g. hypoxic burden) with medical history data, diagnosis biomarker, therapy pressure and sleep stage plus analysis of deviations between different calculation methods
identification of correlation of modern versus classic diagnostic sleep apnea syndrome markers
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start2 Dec 2024
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Löwenstein Medical Technology GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Winfried Randerath, Prof. Dr., Principal investigator, Krankenhaus Bethanien (Solingen), Klinik für Pneumologie und Allergologie/Zentrum für Schlaf- und Beatmungsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317077
- Sponsor's protocol ID
- I5-R1-C-FA
- Acronym
- EventLAB FF
- Status last verified
- Nov 2024
- First submitted
- 2 Mar 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
- ClinicalTrials.gov ID
- NCT06317077
- Acronym / sponsor ID
- EventLAB FF / I5-R1-C-FA
- Conditions
- Sleep Apnea Syndromes
- Keywords
- sleep-related breathing disorders, obstructive sleep apnea, event classification, device, full face mask, apnea-hypopnea-index, polysomnography, accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Löwenstein Medical Technology GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Other: PAP therapy setting, Other: exclusive use of Löwenstein Medical full face masksAll participants of the clinical investigation undergo the standard stages of the clinical routine within an initial PAP therapy setting: a diagnostic night followed by a titration night (or if necessary two titration nights) with prescribed titration scheme. All participants use a full face mask of Löwenstein Medical. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAP therapy settingSubtherapeutic phases during titration to provoke breathing events after reaching the pressure level with which the breathing events are sufficiently treated | Other | Treatment group |
| exclusive use of Löwenstein Medical full face masksUse of a Löwenstein Medical full face mask as a requirement for participation in the clinical investigation | Other | Treatment group |
Primary outcome
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
Time frame: 1 night
comparison of PSG AHI (according to AASM hypopnea scoring rule 1A and 1B) and device AHI for the period in which the records of both devices are available
14 secondary outcomes
N_AE device [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration
Time frame: 1 night
Mask fit score= Leakage, pressure points, stable pressure level, comfort determined via questionnaire
Time frame: 1 night
N_AE mask [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration
Time frame: 1 night
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
Time frame: 1 night
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
Time frame: 1 night
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
Time frame: 1 night
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
Time frame: 1 night
Delta AHI_1A [n/h]= difference between apnea indices using scoring rule 1A from AASM manual version 3.0
Time frame: 1 night
Delta AHI_1B [n/h]= difference between apnea indices using scoring rule 1B from AASM manual version 3.0
Time frame: 1 night
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
Time frame: 1 night
Delta AHI_Routine [n/h]= difference between unmachined apnea indices of device and PSG
Time frame: 1 night
N_impact factors [n]= number and type of factors that can increase the risk for sleep related breathing disorders like comorbidities and smoking
Time frame: 1 night
corr_flow-sleep= correlation between flow signal and sleep state
Time frame: 1 night
calc_marker = possible correlations of calculated sleep apnea syndrome markers (e. g. hypoxic burden) with medical history data, diagnosis biomarker, therapy pressure and sleep stage plus analysis of deviations between different calculation methods
Time frame: 1 night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Randerath, Prof. Dr. principal investigator
Krankenhaus Bethanien (Solingen), Klinik für Pneumologie und Allergologie/Zentrum für Schlaf- und Beatmungsmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAP therapy setting and exclusive use of Löwenstein Medical full face masks in people with Sleep Apnea Syndromes, run by Löwenstein Medical Technology GmbH & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.