Assessing a new lead location for sleep apnea treatment during cardiac device implantation

Transvenous Nerve Stimulation Study (Janus Study)

This study is testing a new way to place a lead during heart device surgery to see if it can help improve breathing and sleep apnea in adults with moderate to severe central sleep apnea.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Respicardia, Inc. (industry)
• Locations: 3 sites (Winston-Salem, North Carolina and 2 other locations)
• Trial ID: NCT03985527 on ClinicalTrials.gov

What this trial studies

This feasibility study aims to evaluate the impact of an alternative transvenous lead location on respiration and airway physiology in patients undergoing the implantation of the remedē® System or other transvenous cardiac devices like pacemakers or implantable cardiac defibrillators. The study will involve patients with moderate to severe central sleep apnea who are at least 18 years old and are willing to provide informed consent. The intervention focuses on transvenous nerve stimulation to potentially improve outcomes related to sleep apnea during these procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe central sleep apnea who are scheduled for a de novo cardiac device implantation.

Not a fit: Patients who are medically unstable, pregnant, or have a BMI over 40 kg/m2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved respiratory function and better management of sleep apnea in patients undergoing cardiac device implantation.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.

Eligibility criteria

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

Where this trial is running

Winston-Salem, North Carolina and 2 other locations

• Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States (RECRUITING)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)
• Bryn Mawr Medical Specialists Association — Bryn Mawr, Pennsylvania, United States (RECRUITING)

Study contacts

• Study coordinator: Samantha Bruning

Conditions: Sleep Apnea Syndromes