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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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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