Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep

Completed

• Conditions: Obstructive Sleep Apnoea
• Interventions: Device: Ultrafast Magnetic Resonance Imaging

• Registration Number: NCT01687855
• Lead Sponsor: Wenzhou Medical University

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 Timeline

• Study Start: 2003-02
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Study First Posted: 2012-09-19
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSAHS group	Ultrafast Magnetic Resonance Imaging	Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway .
normal group	Ultrafast Magnetic Resonance Imaging	Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway .

Primary Outcome Measures

Name	Time	Method
the distance from the tongue to X axis and Y axis	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 Outcome Measures

Name	Time	Method
the tongue size	one night

Trial Locations

Locations (1)

The Tenth Hospital Affiliated to Tongji University; 🇨🇳 Shanghai, Shanghai, China