This study is about a device called the remedē System, used for treating central sleep apnea (CSA). CSA is a condition where your breathing stops and starts during sleep because your brain doesn't send the right signals to the muscles that control breathing. This study is looking at how safe and effective the remedē System is in real-world conditions. It involves at least 500 people from the U.S. and Europe, and it's not random, meaning everyone gets the treatment.
To join, you need to: have moderate to severe CSA, be 18 or older, and agree to the study rules. You can't join if you're in another study that might interfere, or if you're pregnant or planning to be. This study is open-label, meaning both you and the researcher know what treatment you're getting.
Key Points:
- Participants will be implanted with the remedē System.
- Study involves multiple visits across different locations.
- Participants must not be in any conflicting studies.