Clinical trial NCT04407949: Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography
Official title: Untersuchung Der Übereinstimmung Der Ereigniserkennung Von "prismaLine" Geräten Mit Der Polysomnographie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Keywords: CPAP
Apnea
Hypopnea
event detection
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
Collaborators: name: Heinen und Löwenstein GmbH & Co. KG
First posted: 2020-05-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Every enrolled patient underwent a CPAP - Titration under PSG with predefined pressure steps. Afterwards breathing events are scored manually based on AASM Criteria by a trained study member. The events will be compared with the readout from the CPAP Device.
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP machines with manual scored polysomnography (PSG).

Detailed description: The evaluation of residual sleep disordered breathing (SDB) in sleep apnea (SA) after initiation of continuous positive airway pressure (CPAP) therapy is important to verify the therapeutic success. In clinical practice, the internal records of CPAP devices are utilized to determine the therapeutic success, during either medical consultations or telemetric observation.

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.

Eligibility criteria: Inclusion Criteria:

* PSG diagnostic not older than 3 month,
* AHI\>15, CPAP indication,
* age \>18,
* nasal CPAP mask,
* written informed consent

Exclusion Criteria:

* CPAP contraindication,
* participation in another clinical trial

Primary outcomes:
measure: apnea- hypopnea- index (AHI)
timeFrame: up to 8 hours
Secondary outcomes:
measure: hypopnea index relating to oxygen desaturation
timeFrame: up to 8 hours
measure: central and obstructive hypopnea index
timeFrame: up to 8 hours
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
state: NRW
Study officials:
affiliation: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
name: Georg Nilius, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.