ACCCESS
Brief description of study
The overall objective of this study is to evaluate the safety and effectiveness of the Genio® System in treating patients diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant of/failed/refused PAP treatments and present with complete concentric collapse (CCC) at the soft palate level (velopharynx) as diagnosed through a drug induced sleep endoscopy (DISE). percentage of responders based on change in apnea-hypopnea index (AHI4) and oxygen desaturation index (ODI4) at 12 months post-implant. - Sleep-specific function measured by the Functional Outcomes of Sleep Questionnaire (FOSQ-10)
- OSA-specific quality of life measured by the Symptoms of Nasal Obstruction & Related Events (SNORE-25) instrument
- Sleep propensity measured by the Epworth Sleepiness Scale (ESS)
-Quality of Life measured by EuroQol-5 Dimension (EQ-5D-5L)
- Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC)
- Subject satisfaction
- Change in AHI4 from baseline PSG
- Intermittent hypoxia as measured by the ODI4
- OSA severity measured by the AHI4
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: - 99 Years
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Gender: All
TBD
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