The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System

Inclusion Criteria: * Previously diagnosed or screened with moderate to severe sleep apnea who have an AHI of between 15 and 60 * Age between 18 and 65 * Body mass index (BMI) \</= 32 * Patient has been offered CPAP and has refused or failed to continue CPAP treatment * Identified evidence of airway collapse at the base of the tongue * Signed informed consent Exclusion Criteria: * Prior OSA surgery except tonsillectomy, adenoidectomy, and nasal surgery * Enlarged tonsils (3+ and 4+) * Anatomy unable to accommodate the implant * Severe mandibular deficiency/retrognathia * Significant rhinitis/nasal obstruction * Unable and/or not willing to comply with treatment follow-up requirements * Pregnancy (female subjects of childbearing age mus have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study) or breastfeeding * Active systemic infection * Allergy to latex or any medication used during implantation * Previous history of neck or upper respiratory tract cancer * History of radiation therapy to neck or upper respiratory tract * Dysphagia * History of major cardiovascular disorders including MI, angina, uncontrolled hypertension, and CHF * Major pulmonary disorders including COPD and uncontrolled asthma * Patient is suffering from untreated/inadequately treated major depression, as determined by history * History of falling asleep driving or motor vehicle accident secondary to excessive sleepiness * Anesthesia risk group ASA Class IV or V * Other medical, social or psychological problems that, in the opinion of the investigator, could complicate the procedure and/or recovery from this treatment or could complicate the procedures and evaluations pre- and post-treatment * Enrollment in another pharmacological or medical device study