๐๏ธ Verified NIH Record โข Updated 2025-10-28
Janus II Feasibility (NCT06556693)
๐ข Recruiting Observational / Diagnostic โ๏ธ Medical Device Protocol Sponsor: Zoll Medical Corporation
๐ฉบ Plain-English Summary (8th-Grade Level)
The objectives of this study are to evaluate the feasibility of the remedฤยฎ Dual Channel System at implant and overnight sleep studies and to assess chronic safety.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (15 items).
Location: The Insomnia and Sleep Institute of Arizona LLC โ Scottsdale, Arizona
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (3 Sites)
- The Insomnia and Sleep Institute of Arizona LLC โ Scottsdale, Arizona
- The University of Michigan Health-West โ Wyoming, Michigan
- The Ohio State University โ Columbus, Ohio
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.