Obstructive Sleep ApnoeaNCT01687855
Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep
An observational study of Obstructive Sleep Apnoea, run by Wenzhou Medical University at 1 site in China.
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) Read more about this study
- Who is it for?
- Ages 40 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea
- What is being tested?
- Ultrafast Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- Feb 2003to May 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- patients didn't sign written informed consent
- Any situation or condition that will interfere with adherence to study activities
Trial locations and contacts
1 site in 1 country.
China1 site
The Tenth Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: 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)
Read the 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.
- Conditions
- Obstructive Sleep Apnoea
- Being tested
- Ultrafast Magnetic Resonance Imaging
- Keywords
- Obstructive Sleep, Apnoea, tongue, alteration
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| OSAHS group | Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway . Receives: 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 . Receives: Device: Ultrafast Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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；
Measured: one night
Secondary outcomes (1)
the tongue size
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startFeb 2003
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApnoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RongD Hu, Wenzhou Medical University
- Investigators
- Rong D Hu, Ph.D, Study chair, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687855
- Sponsor's protocol ID
- wzmcwyl
- Other IDs
- 0577325
- Status last verified
- Sep 2012
- First submitted
- 11 Sep 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8046629Wang 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.
PubMed 25036504
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Change in Soft Tissue in OSAH
- ClinicalTrials.gov ID
- NCT01687855
- Acronym / sponsor ID
- wzmcwyl
- Conditions
- Obstructive Sleep Apnoea
- Keywords
- Obstructive Sleep, Apnoea, tongue, alteration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSAHS group | – | Device: Ultrafast Magnetic Resonance ImagingSubjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway . |
| normal group | – | Device: Ultrafast Magnetic Resonance ImagingSubjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway . |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- patients didn't sign written informed consent
- Any situation or condition that will interfere with adherence to study activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrafast Magnetic Resonance ImagingMRI 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. | Device | OSAHS group, normal group |
Primary outcome
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；
1 secondary outcome
the tongue size
Time frame: one night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- Background: PubMed 8046629Horner 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.
- Derived from this study: PubMed 25036504Wang 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.
- Sleep ApneaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong D Hu, Ph.D study chair
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnoea, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the distance from the tongue to X axis and Y axis (time frame: one night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.