Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography
- Conditions
- Sleep Apnea Syndromes
- Interventions
- Other: CPAP Treatment
- Registration Number
- NCT04407949
- Lead Sponsor
- Institut für Pneumologie Hagen Ambrock eV
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- PSG diagnostic not older than 3 month,
- AHI>15, CPAP indication,
- age >18,
- nasal CPAP mask,
- written informed consent
- CPAP contraindication,
- participation in another clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description event detection CPAP Treatment -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
🇩🇪Essen, NRW, Germany