NCT06556693NARecruiting
Janus II Feasibility
Zoll Medical Corporation
Start Date
8/12/2025
Completion Date
12/1/2034
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 Criteria
Age Range: 22 years to No maximum
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
Interventions
DEVICE
Dual Channel Stimulation
Conditions
Sleep Apnea
Locations
The Insomnia and Sleep Institute of Arizona LLC
Scottsdale, Arizona 85255
United States
The University of Michigan Health-West
Wyoming, Michigan 49519
United States
The Ohio State University
Columbus, Ohio 43210
United States