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NCT06317077: EventLAB FF
Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
NA trial testing PAP therapy setting in Sleep Apnea Syndromes in 48 participants. Status unknown.
15 May 2025
Quick facts
| Lead sponsor | Löwenstein Medical Technology GmbH & Co. KG |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 15 May 2024 |
| Primary completion | 15 May 2025 |
| Estimated completion | 15 May 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- PAP therapy setting
- exclusive use of Löwenstein Medical full face masks
Conditions studied
- Sleep Apnea Syndromes — all drugs for Sleep Apnea Syndromes →
Sponsor
Löwenstein Medical Technology GmbH & Co. KG
Who can join
Adults 18 to 80, any sex, with Sleep Apnea Syndromes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06317077
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06317077 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Löwenstein Medical Technology GmbH & Co. KG
- Last refreshed: 19 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06317077.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing