Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep

September 18, 2012 updated by: RongD Hu, Wenzhou Medical University

Observation of the Change in Soft Tissue in OSAH

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • The Tenth Hospital Affiliated to Tongji University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Subjects are recruited prospectively from the Tenth Hospital Affiliated to Tongji University of Shanghai,with varying degrees of symptoms of OSAHS (daytime sleepiness, snoring and/or nocturnal apneas).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSAHS group
Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway .
Device: Ultrafast Magnetic Resonance Imaging
MRI was performed with a 1.5 superconducting magnet (Gyroscan Intera type, Philips Co. Holland) in a posterior and anterior neck coil. The sequence used to perform the ultrafast MRI was a fast gradient- echo plus sequence. Technical parameters included: echo time, 12 msec; repetition time, 2.3 msec; flap angle, 250; matrix, 192 × 512; section thickness, 7 mm. The imaging time per slice for this sequence was 0.92 sec. A total of 120 consecutive images were obtained as a single section, with a total imaging time of 110.4 seconds. MRI scanning was carried out with the subject first asleep, then whilst awake after 20 minutes in quiet respiration. All images were inputted to the PACS workstation.
normal group
Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway .
Device: Ultrafast Magnetic Resonance Imaging
MRI was performed with a 1.5 superconducting magnet (Gyroscan Intera type, Philips Co. Holland) in a posterior and anterior neck coil. The sequence used to perform the ultrafast MRI was a fast gradient- echo plus sequence. Technical parameters included: echo time, 12 msec; repetition time, 2.3 msec; flap angle, 250; matrix, 192 × 512; section thickness, 7 mm. The imaging time per slice for this sequence was 0.92 sec. A total of 120 consecutive images were obtained as a single section, with a total imaging time of 110.4 seconds. MRI scanning was carried out with the subject first asleep, then whilst awake after 20 minutes in quiet respiration. All images were inputted to the PACS workstation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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；
one night

Secondary Outcome Measures

Outcome Measure
Time Frame
the tongue size
Time Frame: one night
one night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Study Chair: Rong D Hu, Ph.D, Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wzmcwyl
  • 0577325 (Other Identifier: wenzhou medical college)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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