Clinical Research Directory

Inclusion Criteria: * Subject does not tolerate, not compliant to, or have access to alternative Sleep Disordered 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 supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness. * Any reason for which, in the judgement of the investigator, the subject is considered to 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 confound functional assessments of sleepiness * Subject has severe chronic kidney disease * Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that 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 beverages for 24 hours prior to the start of each PSG study * Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices * Subject has an active systemic infection at the time of implant * Subject has clinical evidence of immunodeficiency * Any condition likely to require future MRI or diathermy * Subject is pregnant * Subject has 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 for cancer or congenital malformations in the larynx, tongue, or throat