An observational study in Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome and Central Sleep Apnea, sponsored by Zoll Medical Corporation. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Zoll Medical Corporation · Observational
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.
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's planned enrollment of 300 is above the median of 148 across 36 observational studies indexed under Sleep Apnea, Central.
Browse Sleep Apnea, Central studies →Zoll Medical Corporation is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who are candidates to be implanted or have been implanted (but not yet been activated) with a de novo commercial remedē System implant and meet the entry criteria are eligible for inclusion in this study.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
remede System
Incidence of serious adverse events (SAEs) related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant
Time frame: From implant to 12 months post implant
Changes in central sleep apnea after 12 months of therapy
Changes in central apnea hypopnea index (CAHI)
Time frame: From baseline to 12 months post therapy activation
Changes in sleep apnea after 12 months of therapy
Changes in apnea hypopnea index (AHI)
Time frame: From baseline to 12 months post therapy activation
Changes in daytime sleepiness after 12 months of therapy
Change in Epworth Sleepiness Scale from baseline to 12 months
Time frame: From baseline to 12 months post therapy activation
Incidence of non-serious adverse events (AEs) related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant
Time frame: From implant to 12 months post implant
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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