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Abstract
Objective: Airway management is the standard approach for the treatment of obstructive sleep apnea (OSA). CPAP remains the gold standard to treat OSAS, but about one-quarter of the patients are poorly compliant or tolerant to the mask. The aim of the study was to evaluate the safety and efficacy of targetted neurostimulation of the hypoglossal nerve (THN Sleep Therapy) in CPAP non-compliant subjects using the aura6000™ System from ImThera Medical Inc. Method: The study was a single arm, prospective feasibility study on 13 OSA subjects. Apnea-hypopnea indices (AHI) were measured at 3 and 12 months. A multi-contact cuff electrode was implanted unilaterally on the proximal hypoglossal nerve and an implantable pulse generator placed subcutaneously in the ipsilateral upper chest wall. Results: Significant improvement was found in the apnea hypopnea index: baseline 45.2 ± 17.8, 3 months 21.7 ± 19.9, and 12 months 21.0 ± 16.5 calculated for the 13 patients. Ten patients were classified as responders (76.92%) with a 65.55% improvement in the AHI at 3 months and 68.19% at 12 months and with a 67.09% improvement in the ODI at 3 months and 66.23% at 12 months. Conclusion: THN Sleep Therapy™ proved to be a feasible and effective procedure for the treatment of the moderate to severe CPAP noncompliant OSA subjects.
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