Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device prismaLine With Polysomnography

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Untersuchung Der Übereinstimmung Der Ereigniserkennung Von prismaLine Geräten Mit Der Polysomnographie

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Other: CPAP Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: event detection<br> | Other: CPAP Treatment<br>* Comparing events from the CPAP device with the events scored in PSG<br>* Other names: PrismaLine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas. | up to 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, Apnea, Hypopnea, event detection