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Clinical Trials in the USA / NCT06556693
Recruiting Not applicable

Janus II Feasibility

NCT06556693 · tracked via the Priya Life Science USA tracker
Sponsor
Zoll Medical Corporation
Phase
Not applicable
Started
2025-08-12
Last updated
2025-10-29

Condition(s) studied

Sleep Apnea

Investigational drug(s) / intervention(s)

Dual Channel Stimulation

Dual Channel Stimulation: implant of dual channel stimulation device

Study 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
The Insomnia and Sleep Institute of Arizona LLC Scottsdale Arizona Recruiting
The University of Michigan Health-West Wyoming Michigan Recruiting
The Ohio State University Columbus Ohio Recruiting

More Zoll Medical Corporation trials in the USA

Pre-hospital Ventilation Clinical Study Enrolling by invitation
AED 3 Post-Approval Study Active, not recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06556693 on ClinicalTrials.gov ↗ ← All trials in the USA