Janus II: dual-channel implant for severe sleep apnea

Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy

This study will test a dual-channel implant (remedē® Dual Channel System) in adults with severe sleep apnea to see if it can be implanted safely and improve breathing during sleep.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Zoll Medical Corporation (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 3 sites (Scottsdale, Arizona and 2 other locations)
• Trial ID: NCT06556693 on ClinicalTrials.gov

What this trial studies

This is an interventional feasibility study of the remedē® Dual Channel System that involves surgical implant of a dual-channel neurostimulation device and overnight sleep studies. Participants with severe sleep-disordered breathing who can tolerate the procedures will receive the implant and undergo scheduled overnight assessments to monitor device performance and sleep measures. The study will also track participants over time to collect data on chronic safety and any device-related adverse events. Many common exclusions apply (for example severe COPD, pacemaker dependence, recent infection, need for MRI, prior neck surgery/radiation) that limit eligibility.

Who should consider this trial

Good fit: Adults with severe sleep-disordered breathing who can tolerate an implant procedure and do not have exclusionary conditions such as uncontrolled COPD, pacemaker dependence, recent infection, need for MRI, or prior cervical surgery/radiation are the ideal candidates.

Not a fit: Patients with contraindications listed in the protocol — for example pacemaker dependence, severe COPD or pulmonary hypertension, active infection within 30 days, significant kidney failure, or a need for MRI — are unlikely to be eligible or to receive benefit from participation.

Why it matters

Potential benefit: If successful, the device could provide a new implantable option to reduce breathing pauses and improve sleep quality for people with severe sleep apnea.

How similar studies have performed: Implantable neurostimulation systems for sleep apnea, including earlier remedē devices for central sleep apnea, have demonstrated clinical benefit in prior studies, though the dual-channel configuration used here is less well established and is being tested for feasibility.

Eligibility criteria

Inclusion Criteria:

* Severe sleep disordered breathing
* Expected to tolerate study procedures
* No heart failure or medically stable heart failure

Exclusion Criteria:

* Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
* History of severe COPD or pulmonary arterial hypertension
* Current or previous history of nerve injury or palsy
* Prior cervical surgeries or radiation treatment to head region
* Known need for an MRI
* History of psychosis or severe bipolar disorder
* Active Infection or sepsis within 30 days of enrollment
* Currently on kidney dialysis or significantly reduced kidney function
* Hemoglobin less than 8g/dl
* Pacemaker dependance
* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months
* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures
* Allergy to contrast dye unless can be prophylactically treated
* Known pregnancy or planning to become pregnant

Where this trial is running

Scottsdale, Arizona and 2 other locations

• The Insomnia and Sleep Institute of Arizona LLC — Scottsdale, Arizona, United States (Recruiting)
• The University of Michigan Health-West — Wyoming, Michigan, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Samuel Kolapo

Conditions Sleep Apnea