Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea
|ClinicalTrials.gov Identifier: NCT00753077|
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : September 5, 2011
|Condition or disease|
|Sleep Apnea, Obstructive|
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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Observational Model:||Case Control|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753077
|School of Dentistry, National Taiwan University|
|Taipei City, Taiwan|