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Janus II Feasibility

Recruiting

Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy

Who can join

Ages 22 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Zoll Medical Corporation · Participants: 40 · Started: Aug 12, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06556693

Locations in the U.S.

ArizonaThe Insomnia and Sleep Institute of Arizona LLC, Scottsdale
MichiganThe University of Michigan Health-West, Wyoming
OhioThe Ohio State University, Columbus

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.