Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea

NCT ID: NCT00753077

Last Updated: 2011-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-12-31

Brief Summary

Oral appliances, which can maintain patients' jaw forwards during sleep, become more popular in treating obstructive sleep apnea (OSA). However, the exact mechanism of mandible forward on upper airway is not completely known. In this study we will use both static and dynamic MRI to study the 3D morphological changes and dynamic behavior of the upper respiratory tract at different mandible posits. Because in asian society non-obese OSA patients are not uncommonly seen, in this study we focus only on non-obese severe OSA patients.

Detailed Description

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Severe obstructive sleep apnea (AHI>=30/hr) age, sex, BMI match control subject

Exclusion Criteria

• Patients were excluded when:

• (1) refused to participate in this study,
• (2) had severe obstructive pulmonary disease or active neurological events,
• (3) enrolled in other studies at the same time

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Hospital

hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Dentistry, National Taiwan University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

200804052R

Identifier Type: -

Identifier Source: org_study_id