Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515580
Status:
TERMINATED
Last Update Posted:
2012-12-20
First Post:
2007-08-12
Brief Title:
Minimally Invasive Tongue Suture For Obstructive Sleep Apnea
Sponsor:
West Side ENT
Organization:
West Side ENT
Study Overview
Official Title:
Minimally Invasive Genioglossus And Hyoid Advancement For Obstructive Sleep Apnea Using Silhouette Sutures A Pilot Study
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Results from first few subjects was not significantly improved over standard traditional procedures
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study to determine the usefulness of a newly developed minimally invasive tongue suture procedure for people with obstructive sleep apnea
Detailed Description:
Obstructive sleep apnea is a common sleep-breathing disorder characterized by repetitive complete cessation of breathing due to pharyngeal obstruction Untreated it has been strongly associated with daytime sleepiness hypertension depression coronary artery disease stroke and even death It is estimated that up to 25 of men and 9 of women may suffer from this condition One proposed mechanism of pharyngeal obstruction is that the posterior tongue is susceptible to collapse when supine during sleep which causes further collapse of the soft palate and related structures Treatment includes continuous positive airway pressure CPAP mandibular advancement devices and various surgical options There are many surgical options for treating tongue base collapse many of which are morbid with significant pain and discomfort involved Silhouette Sutures Kolster Methods Inc are designed to hold and grip soft tissues using intermittently placed dissolvable cones spaced by knots It has been used widely for years for facial cosmetic procedures with excellent results and safety record This is a pilot study evaluating the practicality and efficacy of using Silhouette Sutures in an innovative minimally invasive technique that obviates the need for more aggressive and morbid procedures for obstructive sleep apnea
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