Janus Feasibility Study

Sleep Apnea Syndromes Clinical Trial

Official title:

Transvenous Nerve Stimulation Study (Janus Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03985527
• Other study ID #: CR1389
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Respicardia, Inc.
• Contact: Samantha Bruning
• Phone: 507-226-2953
• Email: samantha.bruning[@]zoll.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is at least 18 years old

• Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remede® 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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes

Intervention

Device:
• Transvenous nerve stimulation
Acute transvenous nerve stimulation during a commercial implant of remede® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator).

Locations

Country	Name	City	State
United States	Bryn Mawr Medical Specialists Association	Bryn Mawr	Pennsylvania
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Respicardia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in respiration and airway physiology	The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remede® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant.	During procedure (immediately post-stimulation)