Janus II Feasibility

Not Applicable

Not yet recruiting

• Conditions: Sleep Apnea
• Interventions: Device: Dual Channel Stimulation

• Registration Number: NCT06556693
• Lead Sponsor: Zoll Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Study Start: 2024-10
• Primary Completion: 2028-04
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Dual Channel Stimulation	-

Primary Outcome Measures

Name	Time	Method
Improvement in sleep disordered breathing	12 months post implant	Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.
Safety through 12 months	12 Months post implant	Serious adverse event related to implant procedure, device, or stimulation
Successful Implantation	implant procedure	Successful Implantation of dual channel system