Menu
Recruiting NCT06556693

Janus II Feasibility

No phase Interventional Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual Channel Stimulation.
Who it may be relevant to
Registry conditions: Sleep Apnea. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Dual Channel Stimulation
    implant of dual channel stimulation device

Primary outcome measures

  • Safety through 12 months [Time frame: 12 Months post implant]
  • Successful Implantation [Time frame: implant procedure]
  • Improvement in sleep disordered breathing [Time frame: 12 months post implant]

Eligibility 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • The Insomnia and Sleep Institute of Arizona LLC — Scottsdale
  • The University of Michigan Health-West — Wyoming
  • The Ohio State University — Columbus

Identifiers

NCT: NCT06556693 · CIP3429

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗