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NCT06556693NARecruiting

Janus II Feasibility

Zoll Medical Corporation

Start Date

8/12/2025

Completion Date

12/1/2034

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.

Eligibility Criteria

Age Range: 22 years to No maximum

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

Interventions

DEVICE

Dual Channel Stimulation

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Conditions

Sleep Apnea

Locations

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