Status:
RECRUITING
Janus II Feasibility
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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
Inclusion
- Severe sleep disordered breathing
- Expected to tolerate study procedures
- No heart failure or medically stable heart failure
Exclusion
- 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
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2034
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06556693
Start Date
August 12 2025
End Date
December 1 2034
Last Update
October 29 2025
Active Locations (3)
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1
The Insomnia and Sleep Institute of Arizona LLC
Scottsdale, Arizona, United States, 85255
2
The University of Michigan Health-West
Wyoming, Michigan, United States, 49519
3
The Ohio State University
Columbus, Ohio, United States, 43210