Status:
UNKNOWN
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Lead Sponsor:
Miller, Chipp St. Kevin, M.D.
Conditions:
Snoring
Sleep Apnea Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- Presence of Wisdom teeth (third molars)
- active oral disease
- acute illness
- BMI (body mass index) \> 30
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00211627
Start Date
June 1 2004
End Date
June 1 2006
Last Update
September 21 2005
Active Locations (1)
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1
Chipp St. Kevin Miller M.D.
Santa Monica, California, United States, 90404