- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00753077
Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Taipei City, Taiwan
- School of Dentistry, National Taiwan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200804052R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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