Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
- Conditions
- SnoringSleep Apnea Syndromes
- Registration Number
- NCT00211627
- Lead Sponsor
- Miller, Chipp St. Kevin, M.D.
- Brief Summary
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- Presence of Wisdom teeth (third molars)
- active oral disease
- acute illness
- BMI (body mass index) > 30
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Reduction/Elimination of snoring behavior
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chipp St. Kevin Miller M.D.
🇺🇸Santa Monica, California, United States