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Recruiting

NCT Number: NCT06556693

Janus II Feasibility

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.

Recruiting

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Insomnia and Sleep Institute of Arizona LLC, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual Channel Stimulation

Device

implant of dual channel stimulation device

Primary outcomes

  1. Safety through 12 months

    Time frame: 12 Months post implant

    Serious adverse event related to implant procedure, device, or stimulation

  2. Successful Implantation

    Time frame: implant procedure

    Successful Implantation of dual channel system

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy McPherson

CONTACT

[email protected]

615-613-6321

Samuel Kolapo

CONTACT

[email protected]

205-441-9519

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2034
First posted
Aug 16, 2024
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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