The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
This study is a multicenter, prospective single arm PMCF. Following activation of the Genio® system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Hypoglossal nerve stimulation system
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
Antwerp, Belgium
Universitair Ziekenhuis Antwerpen
Incidence of device-related Serious Adverse Events (SADEs)
Incidence of device-related Serious Adverse Events (SADEs)
Time frame: 12 months post-surgery
Change in Apnea-Hypopnea Index from baseline
Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab
Time frame: 12 months post-surgery
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 12 months post-surgery
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