NCT01687855

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

3.2 years

First QC Date

September 11, 2012

Last Update Submit

September 18, 2012

Conditions

Obstructive Sleep Apnoea

Keywords

Obstructive SleepApnoeatonguealteration

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • the tongue size

    one night

Study Arms (2)

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

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

Interventions

Ultrafast Magnetic Resonance ImagingDEVICE

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.

OSAHS groupnormal group

Eligibility Criteria

Age40 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Tenth Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (2)

  • 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.

    PMID: 8046629BACKGROUND

  • Wang Y, Mcdonald JP, Liu Y, Pan K, Zhang X, Hu R. Dynamic alterations of the tongue in obstructive sleep apnea-hypopnea syndrome during sleep: analysis using ultrafast MRI. Genet Mol Res. 2014 Jun 17;13(2):4552-63. doi: 10.4238/2014.June.17.7.

    PMID: 25036504DERIVED

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveApnea

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rong D Hu, Ph.D

    Wenzhou Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 19, 2012

Study Start

February 1, 2003

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

CN(1)