This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
45
Neuro Stimulator for treating sleep disordered breathing
Sanatorio Americano
Asunción, Paraguay, Paraguay
RECRUITINGSafety Endpoint - assessment of procedure or device related adverse events
Incidence of adverse events (AEs) related to the Lunair system or procedure
Time frame: enrollment to 12 months post-implant
Improvement in sleep disordered breathing per sleep study
Improvement in sleep disordered breathing at 6, 12 and 24 months post implant during an attended sleep study
Time frame: six months, 12 month and 24 months post implant
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