Can a sleep apnea machine match the gold standard in detecting breathing pauses?
NCT ID NCT06317077
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This study evaluates whether prismaLINE PAP devices accurately count breathing events (apneas and hypopneas) compared to the gold-standard polysomnography (PSG) in people with sleep apnea. Participants will use a full face mask during a titration night, where the device briefly lowers pressure to provoke breathing events. The goal is to see if the device's apnea-hypopnea index (AHI) matches the manually scored PSG, and to confirm the safety and performance of the device and mask.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PAP therapy with subtherapeutic phases to provoke breathing events, using Löwenstein Medical full face masks
- What this could lead to
- If successful, this could confirm that prismaLINE devices reliably measure breathing events, potentially improving home monitoring of sleep apnea therapy.
- What could go wrong
- This is a small, early-stage device validation study, not a treatment trial. Results may not apply to other devices or mask types, and the induced breathing events may not reflect real-world conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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49 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Krankenhaus Bethanien
Solingen, North Rhine-Westphalia, 42699, Germany
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