NCT00753077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 5, 2011

Status Verified

September 1, 2011

Enrollment Period

1.3 years

First QC Date

September 14, 2008

Last Update Submit

September 2, 2011

Conditions

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients referred from sleep center

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, National Taiwan University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
hospital

Study Record Dates

First Submitted

September 14, 2008

First Posted

September 16, 2008

Study Start

August 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

September 5, 2011

Record last verified: 2011-09

Locations