Janus II: dual-channel implant for severe sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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
* 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 it's running

• 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
• Houston Methodist Institute
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Samuel Kolapo
• Email: samuel.kolapo@zoll.com
• Phone: 205-441-9519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neurostimulation treatment for sleep apnea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.