Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to
 treat simple snoring.
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