Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography
NCT ID: NCT04407949
Last Updated: 2020-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2019-01-17
2020-09-30
Brief Summary
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Detailed Description
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This study was designed to evaluate the quality of SDB Event Indices (EI), which are recorded by the CPAP device (Prisma, Löwenstein Medical Technology).
The detected events of a manual scored polysomnography (PSG) in the sleep laboratory will be compared with the simultaneously recorded events of the CPAP device.
This shall lead to recommendations regarding the situations, and in which degree the event detection of the CPAP devices may be meaningful to determine the therapeutic success of home sleep apnea therapy.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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event detection
CPAP Treatment
Comparing events from the CPAP device with the events scored in PSG
Interventions
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CPAP Treatment
Comparing events from the CPAP device with the events scored in PSG
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AHI\>15, CPAP indication,
* age \>18,
* nasal CPAP mask,
* written informed consent
Exclusion Criteria
* participation in another clinical trial
18 Years
ALL
No
Sponsors
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Heinen und Löwenstein GmbH & Co. KG
INDUSTRY
Institut für Pneumologie Hagen Ambrock eV
INDUSTRY
Responsible Party
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Georg Nilius, PD DR med
medical director of pneumologic department
Principal Investigators
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Georg Nilius, MD
Role: PRINCIPAL_INVESTIGATOR
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
Locations
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Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
Essen, North Rhine-Westphalia, Germany
Countries
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References
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Richter M, Schroeder M, Domanski U, Schwaibold M, Nilius G. Reliability of respiratory event detection with continuous positive airway pressure in moderate to severe obstructive sleep apnea - comparison of polysomnography with a device-based analysis. Sleep Breath. 2023 Aug;27(4):1639-1650. doi: 10.1007/s11325-022-02740-w. Epub 2022 Nov 17.
Other Identifiers
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EventLab
Identifier Type: -
Identifier Source: org_study_id
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