Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
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ClinicalTrials.gov Identifier: NCT00211627
Recruitment Status : Unknown
Verified September 2005 by Miller, Chipp St. Kevin, M.D.. Recruitment status was: Recruiting
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.
Condition or disease
SnoringSleep Apnea Syndromes
Device: KEEPASLEEP enhanced breathing device
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)