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Janus II Feasibility

Zoll Medical Corporation · NCT06556693

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
4
Study start
August 12, 2025
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: Dual Channel Stimulation

Conditions: Sleep Apnea

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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
  • 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

Recruiting US locations

  • The Insomnia and Sleep Institute of Arizona LLC

    Scottsdale, AZ 85255

    Site contact: Claudia Mendoza · 4807453547 · cmendoza@sleeplessinarizona.com

  • The University of Michigan Health-West

    Wyoming, MI 49519

    Site contact: Stefanie Davis · Stefanie.Davis@umhwest.org

  • The Ohio State University

    Columbus, OH 43210

    Site contact: Kalyn Ferguson · Kalyn.Ferguson@osumc.edu

  • Houston Methodist Institute

    Houston, TX 77030

    Site contact: Chinwe Ngumezi · ccngumezi@houstonmethodist.org

Study contacts (from the official record)

  • Samuel Kolapo · 205-441-9519 · samuel.kolapo@zoll.com
  • Janus II Study · JNS02@zoll.com
All sleep studies in Arizona →
Janus II Feasibility (NCT06556693) | Bored Studies