Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy
Zoll Medical Corporation
Summary
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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 * Currentl…
Interventions
- DeviceDual Channel Stimulation
implant of dual channel stimulation device
Locations (3)
- The Insomnia and Sleep Institute of Arizona LLCScottsdale, Arizona
- The University of Michigan Health-WestWyoming, Michigan
- The Ohio State UniversityColumbus, Ohio