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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
implant of dual channel stimulation device
The Insomnia and Sleep Institute of Arizona LLC
Scottsdale, Arizona, United States
RECRUITINGThe University of Michigan Health-West
Wyoming, Michigan, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
RECRUITINGSafety through 12 months
Serious adverse event related to implant procedure, device, or stimulation
Time frame: 12 Months post implant
Successful Implantation
Successful Implantation of dual channel system
Time frame: implant procedure
Improvement in sleep disordered breathing
Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.
Time frame: 12 months post implant
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