Registry of Central Sleep Apnea Patients Undergoing remedē System Implant (ROSTER)

November 6, 2026 updated by: Zoll Medical Corporation

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From implant to 12 months post implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in central sleep apnea after 12 months of therapy
Time Frame: From baseline to 12 months post therapy activation

Changes in central apnea hypopnea index (CAHI)
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 apnea hypopnea index (AHI)
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

Change in Epworth Sleepiness Scale from baseline to 12 months
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
From implant to 12 months post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zoll Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

May 1, 2033

Study Completion (Estimated)

May 1, 2037

Study Registration Dates

First Submitted

October 26, 2026

First Submitted That Met QC Criteria

October 26, 2026

First Posted (Actual)

October 30, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP3978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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