NCT00211627

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Miller, Chipp St. Kevin, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Snoring
• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	KEEPASLEEP enhanced breathing device

Timeline

• Start date: 2004-06-01
• Completion: 2006-06-01
• First posted: 2005-09-21
• Last updated: 2005-09-21

Locations

1 site across 1 country: United States