Actively Recruiting
Janus II Feasibility
Led by Zoll Medical Corporation · Updated on 2025-10-29
40
Participants Needed
3
Research Sites
485 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Janus II Feasibility
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe sleep disordered breathing
- Expected to tolerate study procedures
- No heart failure or medically stable heart failure
You will not qualify if you...
- 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 dependence
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Insomnia and Sleep Institute of Arizona LLC
Scottsdale, Arizona, United States, 85255
Actively Recruiting
2
The University of Michigan Health-West
Wyoming, Michigan, United States, 49519
Actively Recruiting
3
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
S
Samuel Kolapo
CONTACT
K
Kathy McPherson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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