Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211627
Status:
UNKNOWN
Last Update Posted:
2005-09-21
First Post:
2005-09-13
Brief Title:
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers
Sponsor:
Miller Chipp St Kevin MD
Organization:
Miller Chipp St Kevin MD
Study Overview
Official Title:
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 hisher own control The device augments airflow into the posterior pharynx to minimize airway collapsetissue vibration and consequent snoringThe device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None