Neurostimulation for Sleep Disordered Breathing

The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing

This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.

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 judgment 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 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 for cancer or congenital malformations in the larynx, tongue, or throat.