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Can an implanted device retrain breathing to treat central sleep apnea?

NCT ID NCT03884660

Disease control Sponsor: Respicardia, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study follows 225 adults with moderate to severe central sleep apnea who receive the remedē System, an implanted device that stimulates a nerve to help regulate breathing during sleep. Researchers track serious and non-serious side effects and measure changes in sleep quality indicators like apnea-hypopnea index and oxygen levels over 12 months. The goal is to see how safe and effective the device is in real-world conditions, outside of a controlled trial setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remedē System, an implanted device that stimulates the phrenic nerve to restore normal breathing during sleep
What this could lead to
If successful, this study could confirm that the remedē System is a safe and effective long-term treatment for central sleep apnea, offering an alternative to other therapies.
What could go wrong
This is an observational post-market study, not a randomized controlled trial, so results may be less definitive. Risks include implant-related complications and the possibility that the device may not improve sleep metrics for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. 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. 2. Age 18 years or older 3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent 4. In the opinion of the investigator, subject is willing and able to comply with the protocol. 5. 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. 6. In the opinion of the Investigator, life expectancy exceeds one year. 7. The subject is not pregnant or planning to become pregnant.

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Conditions

The condition(s) this trial relates to.

central sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central sleep apnea

Contacts and locations

Locations

  • Amphia Longresearch

    Breda, 4818 CK, Netherlands

  • Arizona Heart Rhythm Center

    Phoenix, Arizona, 85016, United States

  • Banner University Medical Center

    Phoenix, Arizona, 85006, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baylor Scott and White - Dallas

    Dallas, Texas, 75246, United States

  • Central Florida Pulmonary Group

    Orlando, Florida, 32803, United States

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Emory University Midtown Hospital

    Atlanta, Georgia, 30329, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medisch Spectrum Twente

    Enschede, 7512 KZ, Netherlands

  • Monument Health

    Rapid City, South Dakota, 57701, United States

  • New Mexico Heart Institute - Lovelace Medical Center

    Albuquerque, New Mexico, 87102, United States

  • New York Presbyterian Hospital-Weill Cornell Medicine

    New York, New York, 10065, United States

  • Northwell Health

    New Hyde Park, New York, 11040, United States

  • Novant Health - Charlotte

    Charlotte, North Carolina, 28204, United States

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103, United States

  • OLVG Amsterdam

    Amsterdam, 1061AE, Netherlands

  • Ohio Sleep Medicine Institute

    Dublin, Ohio, 43017, United States

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • St. Luke's Mid America Heart Institute

    Kansas City, Missouri, 64111, United States

  • The Ohio State Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The University of California San Francisco

    San Francisco, California, 94143, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado Health

    Fort Collins, Colorado, 80528, United States

  • University of Colorado- Anschutz

    Aurora, Colorado, 80045, United States

  • University of Michigan Health West

    Wyoming, Michigan, 49519, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

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