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Janus II Feasibility
Recruiting
Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy
Who can join
Ages 22 and older · All sexes
Full 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
About the study
The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.
What is being tested
- Dual Channel Stimulation (device)
Sponsor: Zoll Medical Corporation · Participants: 40 · Started: Aug 12, 2025
Contact the study team
- Samuel Kolapo · Phone: 205-441-9519
- Kathy McPherson · Phone: 615-613-6321
Official record on ClinicalTrials.gov — NCT06556693
Locations in the U.S.
| Arizona | The Insomnia and Sleep Institute of Arizona LLC, Scottsdale |
| Michigan | The University of Michigan Health-West, Wyoming |
| Ohio | The Ohio State University, Columbus |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.