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

Sleep Apnea Syndromes Clinical Trial

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

Clinical Trial Summary

Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00211627
Study type Interventional
Source Miller, Chipp St. Kevin, M.D.
Contact Chipp K. Miller, M.D.
Phone 310 829-7792
Email waycooldoc@aol.com
Status Recruiting
Phase Phase 1
Start date June 2004
Completion date June 2006
View Details
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