Ignite Creation Date:
2025-12-18 @ 7:42 AM
Ignite Modification Date:
2025-12-23 @ 5:48 PM
Study NCT ID:
NCT00753077
Status:
None
Last Update Posted:
2011-09-05 00:00:00
First Post:
2008-09-14 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea
Sponsor:
None
Organization:
Study Overview
Official Title:
None
Status:
None
Status Verified Date:
2011-09
Last Known Status:
None
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:
The aim of this study is to analyze upper airway morphology changes and dynamic movement at different sections affected by mandible position by using dynamic and static magnet resonance imaging technique. The study also discusses the formation mechanism of obstructive sleep apnea syndromes and function mechanism of the oral appliance, as well as the evaluation of the clinical results of the oral appliance on non-obese male patients with severe obstructive sleep apnea in Taiwan.
10 non-obese (BMI\<25) severe OSA (AHI\>30) male patients between the age of 20 to 60 and 10 gender, BMI and age matched control (AHI\<5) were recruited for this study. Nine bite index were made for the different mandible positions of the subjects.
Upper airway was imaged by using static and dynamic MRI of each subject wearing the bite index while lying on the MRI scanning table. This study also measures the circumference and takes the lateral cephalometric imaging of each subject. Oral appliances were made and fitted for the experimental group subjects, who wore them for three months, after which they transferred to the Sleep Center and underwent PSG examination to evaluate therapeutic effects of the appliances.
10 non-obese (BMI\<25) severe OSA (AHI\>30) male patients between the age of 20 to 60 and 10 gender, BMI and age matched control (AHI\<5) were recruited for this study. Nine bite index were made for the different mandible positions of the subjects.
Upper airway was imaged by using static and dynamic MRI of each subject wearing the bite index while lying on the MRI scanning table. This study also measures the circumference and takes the lateral cephalometric imaging of each subject. Oral appliances were made and fitted for the experimental group subjects, who wore them for three months, after which they transferred to the Sleep Center and underwent PSG examination to evaluate therapeutic effects of the appliances.
Detailed Description:
None
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?: