Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep

Obstructive Sleep Apnoea Clinical Trial

Official title:

Observation of the Change in Soft Tissue in OSAH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687855
• Other study ID #: wzmcwyl
• Secondary ID: 0577325
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: September 18, 2012
• Start date: February 2003
• Est. completion date: May 2006

Study information

• Verified date: September 2012
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
China	The Tenth Hospital Affiliated to Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Horner RL, Innes JA, Morrell MJ, Shea SA, Guz A. The effect of sleep on reflex genioglossus muscle activation by stimuli of negative airway pressure in humans. J Physiol. 1994 Apr 1;476(1):141-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the distance from the tongue to X axis and Y axis	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	No
Secondary	the tongue size		one night	No

External Links

•   Sleep Apnea