Janus II Feasibility
Purpose
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.
Condition
- Sleep Apnea
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts 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 - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention group |
|
Recruiting Locations
The Insomnia and Sleep Institute of Arizona LLC
Scottsdale, Arizona 85255
Scottsdale, Arizona 85255
The University of Michigan Health-West
Wyoming, Michigan 49519
Wyoming, Michigan 49519
More Details
- NCT ID
- NCT06556693
- Status
- Recruiting
- Sponsor
- Zoll Medical Corporation