Janus II Feasibility
Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy
1 other identifier
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 16, 2024
CompletedStudy Start
First participant enrolled
August 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2034
October 29, 2025
October 1, 2025
2.6 years
August 8, 2024
October 28, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Safety through 12 months
Serious adverse event related to implant procedure, device, or stimulation
12 Months post implant
Successful Implantation
Successful Implantation of dual channel system
implant procedure
Improvement in sleep disordered breathing
Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.
12 months post implant
Study Arms (1)
Intervention group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Severe sleep disordered breathing
- Expected to tolerate study procedures
- No heart failure or medically stable heart failure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robin Germany, MD
ZOLL Respicardia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 16, 2024
Study Start
August 12, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
December 1, 2034
Last Updated
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share