Loading clinical trials...

Janus Feasibility Study | Clinical Trials | Clareo Health

COMPLETEDNA

Janus Feasibility Study

Transvenous Nerve Stimulation Study (Janus Study)

NCT03985527•Respicardia, Inc.

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (3)

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Bryn Mawr Medical Specialists Association

Bryn Mawr, Pennsylvania, United States

Key Dates

Start Date

January 9, 2020

Primary Completion Date

December 12, 2025

Completion Date

December 12, 2025

Last Updated

January 30, 2026

Enrollment

ACTUAL participants

Conditions

Sleep Apnea Syndromes

Interventions

Transvenous nerve stimulation

DEVICE

Apnea, Stroke and Incident Cardiovascular Events

NCT04399200

StrokeSleep-disordered Breathing+4 more

View study

ENROLLING_BY_INVITATIONNA

Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea

NCT07169058

Obstructive Sleep Apnea Syndromes

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Janus Feasibility Study

Inclusion Criteria

Exclusion Criteria

Apnea, Stroke and Incident Cardiovascular Events

Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea

Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy

Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Multicenter Study on the Role of Neurodegeneration Biomarkers in Obstructive Sleep Apnea Syndrome With Residual Excessive Daytime Sleepiness.