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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00753077
First received: September 14, 2008
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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
Sleep Apnea, Obstructive

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 20
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients referred from sleep center

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753077

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

No publications provided

Responsible Party: National Taiwan University Hospital, hospital
ClinicalTrials.gov Identifier: NCT00753077     History of Changes
Other Study ID Numbers: 200804052R
Study First Received: September 14, 2008
Last Updated: September 2, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014