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Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RongD Hu, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01687855
First received: September 11, 2012
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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)


Condition Intervention
Obstructive Sleep Apnoea
 Device: Ultrafast Magnetic Resonance Imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observation of the Change in Soft Tissue in OSAH

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wenzhou Medical College:

Primary Outcome Measures:
  • the distance from the tongue to X axis and Y axis [ Time Frame: one night ] [ Designated as safety issue: No ]
    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:
  • the tongue size [ Time Frame: one night ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687855

Locations
China, Shanghai
The Tenth Hospital Affiliated to Tongji University
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Wenzhou Medical College
Investigators
Study Chair: Rong D Hu, Ph.D Wenzhou Medical College
  More Information

Additional Information:
Sleep Apnea  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: RongD Hu, principal investigator, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01687855     History of Changes
Other Study ID Numbers: wzmcwyl, 0577325
Study First Received: September 11, 2012
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wenzhou Medical College:
Obstructive Sleep
Apnoea
tongue
alteration

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

ClinicalTrials.gov processed this record on May 22, 2013