Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.

The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)

Safety and efficacy will be evaluated at Month 7, and again at Month 13.

Abbreviated: Additional criteria may apply:

Inclusion Criteria:

• Diagnosis of moderate to severe OSA
• Declines to use or does not tolerate PAP therapy

Exclusion Criteria:

• Respiratory, cardiac, renal disease or other co-morbid conditions
• BMI > 35 kg/m2
• Specific PSG criteria outlined in the protocol