Janus Feasibility Study

The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvenous nerve stimulation

Device

Acute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator).

Primary outcomes

Changes in respiration and airway physiology

Time frame: During procedure (immediately post-stimulation)

The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant.

Sponsors and collaborators

Lead sponsor

Respicardia, Inc.

Industry

Registry information

Official study title

Transvenous Nerve Stimulation Study (Janus Study)

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Jun 13, 2019
Registry last updated: Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed