Sleep Apnea Syndromes
Conditions
Keywords
CPAP, Apnea, Hypopnea, event detection
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.
Interventions
OTHERCPAP Treatment
Comparing events from the CPAP device with the events scored in PSG
Sponsors
Heinen und Löwenstein GmbH & Co. KG
Institut für Pneumologie Hagen Ambrock eV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| apnea- hypopnea- index (AHI) | up to 8 hours | Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hypopnea index relating to oxygen desaturation | up to 8 hours | 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. |
| central and obstructive hypopnea index | up to 8 hours | total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas. |
Countries
Germany
Outcome results
None listed