Effects of the Inspire(tm) Implantable Nerve Stimulation System on Obstructive Sleep Apnea (Inspire 4)

1. Suffer from moederate to severe OSA (AHI * 20) 2. Have failed or have not tolerated CPAP treatment 3. Age 22 or above 4. Willing and capable of providing informed consent and to return for all follow*up visits and sleep studies, including the evaluation procedures and filling out the questionnaires.

1. Body Mass Index (BMI) of > 32
2. Surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat (Note that some prior surgeries to remove obstructions related to obstructive sleep apnea are allowed; such as uvulopalatopharyngoplasty, tonsillectomy, or adenoidectomy)
3. Hypoglossal nerve palsy (obvious limited tongue movement, such as inability to protrude tongue, or unintended lateral deviation of the tongue when protruding).
4. Previous surgery within 12 weeks of scheduled implant performed on the soft tissue of the upper airway (e.g., uvula, soft palate or tonsils).
5. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction)
6. Intrinsic neuromuscular disease, or other neurologic deficits (for examplee.g., multiple sclerosis, muscular dystrophy, Parkinson*s disease, amyotrophic lateral sclerosis, epilepsy, transient ischemic attack, or cerebrovascular accident)
7. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis), which may be) such as a normal or high FEV1/FVC with an FEV1 less than 50% of predicted, or severe chronic obstructive pulmonary disease (COPD) indicated by FEV1 (forced expiratory volume) < 50% predicted or FEV1/ FVC (forced vital capacity) ratio < 50%
8. Active, severe pulmonary vascular disease (0.7 as defined by the Global Initiative for example pulmonary arterial hypertension or pulmonary embolism)Chronic Obstructive Lung Disease (GOLD); Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease updated 2009
9. Moderate to severe pulmonary arterial hypertension as defined as Class III or higher as defined by the World Health Organization functional class, WHO FC) or documented by direct measurements of mean pulmonary arterial pressure by heart catheterization (PAPmean * 30 mmHg) or estimates of systolic pulmonary arterial pressure by echocardiogram (PAsys * 40 mmHg) [Barst RJ, McGoon M, Torbicki A, et al. Diagnosis and differential assessment of pulmonary arterial hypertension. J Am Coll Cardiol 2004;43:40S-47S]
10. Need for chronic supplemental oxygen therapy for any other reason, pO2 (partial pressure of oxygen) < 55 mm Hg
11. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (< 6 month) myocardial infarction or severe cardiac arrhythmias
12. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
13. Persistent uncontrolled hypertension (defined as systolic pressure *160 mm Hg or a diastolic pressure of * 100 mm Hg) despite medications
14. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents patient compliance with the requirements of the investigational study testing
15. Other sleep disorders that confound functional assessments of sleepiness such as narcolepsy with cataplexy, insomnia, or sleep movement disorders such as restless leg syndrome or periodic limb movement producing sleep disturbances unrelated to obstructive sleep apnea
16. Taking medications that in the opinion of the consulting physician may alter consciousness, the pattern of respiration, or sleep architecture. Medications not given explicitly to impact nighttime sleep may be allowed (e.g. SSRI*s) as long as the dose is stable and is anticipated to remain stable for the next 12 months. Patients with any history of chemical substance abuse within the previous 3 years should also be excluded.
17. Taking blood thinning medications, such as warfarin, aspirin, plavix, or other blood thinning agents which cannot be safely stopped or bridged (by using low molecular weight heparins such as Lovenox) temporarily to allow surgery to take place. This decision should be made in consultation with patient*s cardiologist and/or primary physician managing his/her anticoagulation therapy
18. Diagnosis of coagulopathy
19. Pregnant or plan to become pregnant within the next year
20. Has an implanted electrical stimulation device (for example pacemaker, defibrillator, peripheral nerve stimulator) and/or implanted drug infusion pumps
21. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the investigatorsInvestigators
22. Has a terminal illness with life expectancy < 12 months
23. Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study