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