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Email CoordinatorOverview
REST: Prospective non-randomized post market study collecting clinical data on safety and effectiveness of the Remede System.
Description
This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the Remede System. At least 500 subjects will be successfully implanted at approximately 50 sites in the United States and Europe.
Learn more at clinicaltrials.gov
Eligibility Criteria
Inclusion
Subjects who are determined to be candidates to receive a de novo commercial implant of the Remede System are eligible for inclusion in this trial, subject to the entry criteria.
Entry Criteria:
- Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is recommended that a patient have a PSG within 12 months of the expected implant date documenting moderate to severe CSA.
- Age 18 years or older
- Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent
- In the opinion of the investigator, subject is willing and able to comply with the protocol.
- Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
- In the opinion of the Investigator, life expectancy exceeds one year.
- The subject is not pregnant or planning to become pregnant.