Neurostimulation for Sleep Disordered Breathing

Inclusion Criteria:

• Subject does not tolerate, not compliant to or have access to alternative SleepDisordered Breathing treatments

• Subject has moderate to severe sleep disordered breathing as diagnosed by PSG

Exclusion Criteria:

• Subject is taking opioids, narcotics, sleep or psychotic medications or supplementsthat may alter consciousness, the pattern of respiration, sleep architecture, orwith known effect on sleep-wake function or alertness.

• Any reason for which, in the judgment of the investigator, the subject is consideredto be a poor study candidate

• Subject has previous upper respiratory tract (URT) surgery or procedure (e.g.,uvula, soft palate or tonsils) within 60 days prior to Screening PSG.

• Subject has a need for chronic supplemental oxygen therapy for any reason

• Subject has other sleep disorders or sleep hygiene behaviors that confoundfunctional assessments of sleepiness

• Subject has severe chronic kidney disease

• Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugsthat would impact either the results of or the participation in a sleep study.

• Subject conducts work or regular activities requiring vigilance

• Subject is unwilling or unable to refrain from consumption of alcoholic beveragesfor 24 hours prior to the start of each PSG study.

• Subject is unwilling or unable to refrain from sleep disordered breathing treatmentsor devices

• Subject has an active systemic infection at time of implant.

• Subject has clinical evidence of immunodeficiency.

• Any condition likely to require future MRI or diathermy

• Subject is pregnant

• Subject has a severe nasal obstruction that could restrict airflow

• Subject has any trauma to the upper airway

• Subject has previous surgical resection, prior or current radiation therapy forcancer or congenital malformations in the larynx, tongue, or throat.