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Not Yet Recruiting NCT07907068

Registry of Central Sleep Apnea Patients Undergoing remedē System Implant

Conditions: Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea, Phrenic Nerve Stimulation, Sleep Disordered Breathing (SDB), Sleep Apnea, Central, Sleep Apnea

Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: Zoll Medical Corporation

Summary

The goal of this observational study is to collect information on the safety and performance of the remedē System in patients with central sleep apnea who are undergoing the remedē System implant procedure. The main question\[s\] it aims to answer \[is/are\]: What is the incidence of serious adverse events related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant. Participants will complete 2 home sleep apnea tests and be asked about adverse events. All other data collected will be from standard of care visits.

Eligibility Criteria

Inclusion Criteria: * Age 22 years or older * Baseline sleep study (polysomnogram \[PSG\] or home sleep apnea test \[HSAT\]) within 2 years prior to implant indicating moderate to severe central sleep apnea. The sleep study needs to have hypopneas classified. * Signed Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent * In the opinion of the investigator, subject is willing and able to comply with the protocol. * Not currently enrolled or planning to enroll in any clinical trial/study or registry that may conflict with protocol requirements or confound subject results in this study, unless approved by the sponsor * In the opinion of the investigator, life expectancy exceeds one year * Not pregnant or planning to become pregnant * Has access to a smartphone

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07907068). StuddyBuddy aggregates publicly available trial information.