Janus II Feasibility

Recruiting now · Not applicable

Conditions studied: Sleep Apnea

In brief

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.

Key facts

Study ID: NCT06556693
Run by: Zoll Medical Corporation
People needed: 40
Starts: 2025-08-12
Expected to finish: 2034-12-01
Last updated by the study team: 2025-10-29

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

The Insomnia and Sleep Institute of Arizona LLC — Scottsdale, Arizona, United States (enrolling)
The University of Michigan Health-West — Wyoming, Michigan, United States (enrolling)
The Ohio State University — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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