The purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in adults with obstructive sleep apnea.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Neurostimulation via Restera Serene System
University of Western Australia
Perth, Australia
RECRUITINGSafety of the Restera Serene System
Incidence of device and/or procedure-related serious adverse events
Time frame: 6 months
Effectiveness of the Restera Serene System
Change from baseline in the Apnea-Hypopnea Index
Time frame: 6 months
Long-term Safety of the Restera Serene System
Incidence of device and/or procedure-related serious adverse events
Time frame: 36 months
Long-term Effectiveness of the Restera Serene System
Change from baseline in the Apnea-Hypopnea Index
Time frame: 36 months
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