Janus II Feasibility

ZOLL Medical

Status: Enrolling

Conditions: Sleep Apnea

Treatments: Device: Dual Channel Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06556693

CIP3429

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intervention group

Experimental group

Treatment:

Device: Dual Channel Stimulation