Central Sleep ApnearēSTNCT03884660
remedē System Therapy Study
An observational study of Central Sleep Apnea, run by Respicardia, Inc. at 32 sites in 2 countries.
Trial summary
The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Sleep Apnea
- What is being tested?
- remede System
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 18 Jun 2019to 30 Dec 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are determined to be candidates, independent of this research study, to receive a de novo commercial implant of the remedē System are eligible for inclusion in this trial, subject to the 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 strongly recommended that a patient have a diagnostic 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.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States29 sites
New Mexico Heart Institute - Lovelace Medical Center
Albuquerque, New Mexico, 87102
Emory University Midtown Hospital
Atlanta, Georgia, 30329
University of Colorado- Anschutz
Aurora, Colorado, 80045
Novant Health - Charlotte
Charlotte, North Carolina, 28204
University of Chicago
Chicago, Illinois, 60637
The Ohio State Wexner Medical Center
Columbus, Ohio, 43210
Baylor Scott and White - Dallas
Dallas, Texas, 75246
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
University of Colorado Health
Fort Collins, Colorado, 80528
East Carolina University
Greenville, North Carolina, 27834
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
St. Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
Baptist Health Lexington
Lexington, Kentucky, 40503
West Virginia University
Morgantown, West Virginia, 26506
Northwell Health
New Hyde Park, New York, 11040
New York Presbyterian Hospital-Weill Cornell Medicine
New York, New York, 10065
Central Florida Pulmonary Group
Orlando, Florida, 32803
The Valley Hospital
Paramus, New Jersey, 07652
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Banner University Medical Center
Phoenix, Arizona, 85006
Arizona Heart Rhythm Center
Phoenix, Arizona, 85016
Monument Health
Rapid City, South Dakota, 57701
Mayo Clinic
Rochester, Minnesota, 55905
The University of California San Francisco
San Francisco, California, 94143
HonorHealth
Scottsdale, Arizona, 85258
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
University of Michigan Health West
Wyoming, Michigan, 49519
Netherlands3 sites
OLVG Amsterdam
Amsterdam, 1061AE
Amphia Longresearch
Breda, 4818 CK
Medisch Spectrum Twente
Enschede, 7512 KZ
About this study
Official title: Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
Read the detailed 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 remedē System. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.
- Conditions
- Central Sleep Apnea
- Being tested
- remede System
- Medical subject headings
- Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remede SystemDevice
Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy
Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy
Measured: 5 years
Evaluate changes in sleep disordered breathing metrics after 12 months of therapy
Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation <90%
Measured: 12 months
Secondary outcomes (2)
Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy
Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy
Measured: 5 years
Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy
Change from baseline to 36- and 60-month visits for the following sleep metrics during an at home sleep apnea test (HSAT): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of sleep with oxygen saturation <90%
Measured: 36 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start18 Jun 2019
- Primary completion31 Aug 2026
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Sleep ApneaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Respicardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy McPherson, Study director, ZOLL Respicardia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884660
- Sponsor's protocol ID
- CIP1393
- Acronym
- rēST
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2019
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goldberg LR, Fox H, Stellbrink C, Bozkurt B, Boehmer JP, Mora JI, Doshi R, Morgenthaler TI, Levy WC, Meyer TE, McKane SW, Germany R; remede System Therapy Study Group. Design of the remede System Therapy (reST) study: A prospective non-randomized post-market study collecting clinical data on safety and effectiveness of the remede system for the treatment of central sleep apnea. Sleep Med. 2022 Dec;100:238-243. doi: 10.1016/j.sleep.2022.08.026. Epub 2022 Sep 6.
PubMed 36116293
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
- ClinicalTrials.gov ID
- NCT03884660
- Acronym / sponsor ID
- rēST / CIP1393
- Conditions
- Central Sleep Apnea
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Respicardia, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 21 Mar 2019 (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 purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
Detailed 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 remedē System. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are determined to be candidates, independent of this research study, to receive a de novo commercial implant of the remedē System are eligible for inclusion in this trial, subject to the entry criteria.
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 |
|---|---|---|
| remede SystemPatients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography. | Device | – |
Primary outcome
Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy
Time frame: 5 years
Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy
Evaluate changes in sleep disordered breathing metrics after 12 months of therapy
Time frame: 12 months
Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation <90%
2 secondary outcomes
Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy
Time frame: 5 years
Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy
Time frame: 36 and 60 months
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 2 Sep 2026.
- Derived from this study: PubMed 36116293Goldberg LR, Fox H, Stellbrink C, Bozkurt B, Boehmer JP, Mora JI, Doshi R, Morgenthaler TI, Levy WC, Meyer TE, McKane SW, Germany R; remede System Therapy Study Group. Design of the remede System Therapy (reST) study: A prospective non-randomized post-market study collecting clinical data on safety and effectiveness of the remede system for the treatment of central sleep apnea. Sleep Med. 2022 Dec;100:238-243. doi: 10.1016/j.sleep.2022.08.026. Epub 2022 Sep 6.
- 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. This study is not recruiting at the moment.
Kathy McPherson study director
ZOLL Respicardia, Inc.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sleep Apnea, run by Respicardia, Inc. at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884660, which also lists 1 linked publication.
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 2 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.