Janus II Feasibility

October 28, 2025 updated by: Zoll Medical Corporation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Recruiting
        • The Insomnia and Sleep Institute of Arizona LLC
        • Contact:
        • Principal Investigator:
          • Sriharsha Vajjala, MD
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • The University of Michigan Health-West
        • Contact:
        • Principal Investigator:
          • Timothy Daum, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Ralph Augostini, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Device: Dual Channel Stimulation
implant of dual channel stimulation device

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zoll Medical Corporation

Investigators

  • Study Director: Robin Germany, MD, ZOLL Respicardia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2034

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP3429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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