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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00753077
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : September 5, 2011
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease
Sleep Apnea, Obstructive

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 : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : August 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients referred from sleep center

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00753077

School of Dentistry, National Taiwan University
Taipei City, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital, hospital Identifier: NCT00753077     History of Changes
Other Study ID Numbers: 200804052R
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases