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Tiny study explores better lead placement for sleep apnea device

NCT ID NCT03985527

Knowledge-focused 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small study tested whether placing a nerve stimulation lead in a different spot during a sleep apnea device implant could improve breathing. 29 adults with moderate to severe central sleep apnea took part. The goal was to see immediate changes in breathing and airway function, not long-term treatment effects.

What this could mean

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

Active substance
transvenous nerve stimulation device
What this could lead to
If successful, this could help refine how nerve stimulation devices are placed to better treat sleep apnea.
What could go wrong
This is a very small, early feasibility study with only 29 participants. It only measured immediate effects during the implant procedure, not long-term outcomes. Results may not apply to 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

29 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2025

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.

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.

Inclusion Criteria: * Subject is at least 18 years old * Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® System implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator * Subject is willing and able to give informed consent Exclusion Criteria: * Subject is unable or unwilling to participate with study procedures or in the investigator's opinion is medically unstable for the procedure (Medically unstable is defined as when a patient is expected to have worsening health status if additional procedure time is needed) * Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the implant) * Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator * Subject has body mass index (BMI) \> 40 kg/m2 at the time of implant * Subject has had prior neck surgery * Previous or currently implanted upper airway stimulation device * Subject has had prior oral cavity surgery that may interfere with breathing * Subject has significant upper airway-related anatomic anomaly * Subject is enrolled in concurrent study that may confound the results of this study * Subject is taking muscle relaxant medication unless approved by the site implanter and ZOLL Respicardia clinical staff * Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue

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Conditions

The condition(s) this trial relates to.

central sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Sleep apnea syndromes

Contacts and locations

Locations

  • Bryn Mawr Medical Specialists Association

    Bryn Mawr, Pennsylvania, 19010, United States

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27013, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

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