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| Name | Class |
|---|---|
| Heinen und Löwenstein GmbH & Co. KG | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| event detection | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP Treatment | Other | Comparing events from the CPAP device with the events scored in PSG |
|
| Measure | Description | Time Frame |
|---|---|---|
| apnea- hypopnea- index (AHI) | Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log | up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| hypopnea index relating to oxygen desaturation | total number of Hypopneas (N) and Index (N/h) scored under AASM criteria for hypopneas, both rules. 1A: hypopnea events with >= 3% oxygen desaturation and 1B: hypopnea events with >= 4% oxygen desaturation. | up to 8 hours |
| central and obstructive hypopnea index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Nilius, MD | Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH | Essen | North Rhine-Westphalia | 45276 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36394692 | Derived | 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. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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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.
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total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas. |
| up to 8 hours |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012138 |
| Respiratory Therapy |