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Clinical Trials/NCT01687855
NCT01687855CompletedNot Applicable

Observation of the Change in Soft Tissue in OSAH

Wenzhou Medical University1 site in 1 country41 target enrollmentStarted: February 2003Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
the distance from the tongue to X axis and Y axis

Study Overview

Brief Summary

The aim of this study was to evaluate the dynamic changes of the tongue in patients with obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using Ultrafast Magnetic Resonance Imaging (UMRI)

Detailed Description

UMRI was undertaken on the upper airway in 21 OSAHS patients and 20 normal people after being deprived of sleep for one night. A series of midline sagittal images of the upper airway were obtained. The dynamic alterations of the tongue size and the distance from the tongue to X axis (an extended line from the anterior nasal spine to posterior nasal spine) and Y axis (a perpendicular line from the center of the pituitary to the X axis) were measured.Statistical comparisons between pairs of means were performed via t-tests using Spss10 software. A probability level of p<0.05 was considered to be statistically significant.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • patients who are male
  • patients were diagnosed as OSAHS
  • patients underwent a thorough history (including the Epworth somnolence questionnaire) and physical examination
  • patients did not undergo any treatment
  • each subject gave written informed consent before entering the study.

Exclusion Criteria

  • patients didn't sign written informed consent
  • Any situation or condition that will interfere with adherence to study activities

Outcomes

Primary Outcomes

the distance from the tongue to X axis and Y axis

Time Frame: one night

X axis is an extended line from the anterior nasal spine to posterior nasal spine ; Y axis is a perpendicular line from the center of the pituitary to the X axis;

Secondary Outcomes

  • the tongue size(one night)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

RongD Hu

principal investigator

Wenzhou Medical University

Study Sites (1)

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