Central Sleep Apnea (Diagnosis)ROSTERNCT07907068
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
An observational study of Central Sleep Apnea (Diagnosis) and Central Sleep Apnea Syndrome, run by Zoll Medical Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea
- What is being tested?
- Phrenic nerve stimulation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to May 2037
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
None listed.
About this study
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.
- Conditions
- Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea, Phrenic Nerve Stimulation, Sleep Disordered Breathing (SDB), Sleep Apnea, Central
- Being tested
- Phrenic nerve stimulation
- Keywords
- remede System, Central sleep apnea, CSA, Phrenic nerve stimulation, Sleep disordered breathing, SDB, Sleep apnea
- Medical subject headings
- Sleep Apnea, Central, Disease, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phrenic nerve stimulationDevice
remede System
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events (SAEs) related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant
Measured: From implant to 12 months post implant
Secondary outcomes (4)
Changes in central sleep apnea after 12 months of therapy
Changes in central apnea hypopnea index (CAHI)
Measured: From baseline to 12 months post therapy activation
Changes in sleep apnea after 12 months of therapy
Changes in apnea hypopnea index (AHI)
Measured: 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
Measured: 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
Measured: From implant to 12 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startMar 2027 (estimated)
- Primary completionMay 2033 (estimated)
- Study completionMay 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep Apnea (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907068
- Sponsor's protocol ID
- CIP3978
- Acronym
- ROSTER
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
- ClinicalTrials.gov ID
- NCT07907068
- Acronym / sponsor ID
- ROSTER / CIP3978
- Conditions
- Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea, Phrenic Nerve Stimulation, Sleep Disordered Breathing (SDB), Sleep Apnea, Central
- Keywords
- remede System, Central sleep apnea, CSA, Phrenic nerve stimulation, Sleep disordered breathing, SDB, Sleep apnea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2027 (estimated)
- Primary completion
- May 2033 (estimated)
- Study completion
- May 2037 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phrenic nerve stimulationremede System | Device | – |
Primary outcome
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
4 secondary outcomes
Changes in central sleep apnea after 12 months of therapy
Time frame: From baseline to 12 months post therapy activation
Changes in sleep apnea after 12 months of therapy
Time frame: From baseline to 12 months post therapy activation
Changes in daytime sleepiness after 12 months of therapy
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sleep Apnea (Diagnosis) and Central Sleep Apnea Syndrome, run by Zoll Medical Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.