Janus II Feasibility

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06556693

Enrollment

Registered

2024-08-16

Start date

2025-08-12

Completion date

2034-12-31

Last updated

2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

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.

Interventions

DEVICEDual Channel Stimulation

implant of dual channel stimulation device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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
Improvement in sleep disordered breathing	12 months post implant	Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.

Countries

United States

Contacts

Primary ContactSamuel Kolapo

samuel.kolapo@zoll.com205-441-9519

Backup ContactKathy McPherson

kmcpherson@zoll.com615-613-6321

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026