Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Recruitment status was Recruiting
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.
Sleep Apnea Syndromes
Device: KEEPASLEEP enhanced breathing device
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.|
- Reduction/Elimination of snoring behavior
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||June 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211627
|Contact: Chipp K. Miller, M.D.||310 email@example.com|
|United States, California|
|Chipp St. Kevin Miller M.D.||Recruiting|
|Santa Monica, California, United States, 90404|
|Contact: Chipp K. Miller, M.D. 310-829-7792 firstname.lastname@example.org|
|Principal Investigator:||Chipp K. Miller, M.D.||St. Johns Health Center|