Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.

The Keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance
breathing during sleep. This method has not been described in the medical literature and has
been successful in limited testing. This clinical trial is to determine the safety and
effectiveness of the KEEPASLEEP device utilizing 30 subjects with simple snoring. Each
subject will serve as his/her own control. The device augments airflow into the posterior
pharynx to minimize airway collapse,tissue vibration, and consequent snoring.The device
passes through the retromaxillary space and requires that the subject be absent their wisdom
teeth.

Inclusion Criteria:- 18 yrs. of age or greater

- generally good health

- Intact dentition / ABSENT upper and lower wisdom teeth ( by extraction or lack of
development )

- Simple snoring( documented by observer) or mild sleep apnea RDI < 15 ( documented by
polysomnogram)

- Subject must have a concerned observer to assess of sleep and snoring behavior during
trial period

Exclusion Criteria:- Presence of Wisdom teeth (third molars)

- active oral disease

- acute illness

- BMI (body mass index) > 30