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Completed

NCT Number: NCT01687855

Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep

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)

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Key information

Conditions

Obstructive Sleep Apnoea Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

40 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

The Tenth Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrafast Magnetic Resonance Imaging

Device

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.

Primary outcomes

  1. 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

  1. the tongue size

    Time frame: one night

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

Observation of the Change in Soft Tissue in OSAH

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2012
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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