Obstructive Sleep ApneaNCT00674076
Clinical Application of Ultrasound in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound through submental area is different between normal control with those with obstructive sleep apnea syndrome who was comfirmed by polysomography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2008to Dec 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who are arranged to recived polysomography
Who may be able to join
- group of sleep apnea: patients who have been diagnosed as having obstructive sleep apnea
- control group: patients who have a negative polysomogrphy or a normal score of Pittsburg sleep questionaire
Who cannot join
- Less than 18-year-old
- un-willing
- not co-operated person
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound through submental area is different between normal control with those with obstructive sleep apnea syndrome who was comfirmed by polysomography.
Read the detailed description
Patients with obstructive sleep apnea mainly due to upper airway narrowing are evaluated conventionaly by polysomography. Recently, the magnetic resonace imaging has been well established in evaluating upper airway and correlating with the severity by tongue mass and the area of retropalatal airway. However, some drawbacks of MRI includes expensiveness might lead its less use. As for ultrasound which is very popularly applied in medical illness, is more convenient and money saving than MRI. We propose that ultrsound measuring the tongue volume and width of upper airway through submental area may be a alternative image for a upper airway measuring.
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sleep apnea | a patient has been diagnosed as having obstructive sleep apnea | |
| control | a case who has a negative polysomography or noraml score of Pittsburg sleep questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea-hypopnea index
Measured: less than one month apart from ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao-Chien Wang, MD, PhD, Principal investigator, National Taiwan University Hospital, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674076
- Sponsor's protocol ID
- 200802028R
- Status last verified
- Jun 2012
- First submitted
- 5 May 2008
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
PubMed 23675433
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Ultrasound in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00674076
- Acronym / sponsor ID
- 200802028R
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 May 2008 (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.
We hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound through submental area is different between normal control with those with obstructive sleep apnea syndrome who was comfirmed by polysomography.
Detailed description
Patients with obstructive sleep apnea mainly due to upper airway narrowing are evaluated conventionaly by polysomography. Recently, the magnetic resonace imaging has been well established in evaluating upper airway and correlating with the severity by tongue mass and the area of retropalatal airway. However, some drawbacks of MRI includes expensiveness might lead its less use. As for ultrasound which is very popularly applied in medical illness, is more convenient and money saving than MRI. We propose that ultrsound measuring the tongue volume and width of upper airway through submental area may be a alternative image for a upper airway measuring.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep apnea | – | –a patient has been diagnosed as having obstructive sleep apnea |
| control | – | –a case who has a negative polysomography or noraml score of Pittsburg sleep questionaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are arranged to recived polysomography
Key inclusion criteria (2 listed)
- group of sleep apnea: patients who have been diagnosed as having obstructive sleep apnea
- control group: patients who have a negative polysomogrphy or a normal score of Pittsburg sleep questionaire
Key exclusion criteria (3 listed)
- Less than 18-year-old
- un-willing
- not co-operated person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
apnea-hypopnea index
Time frame: less than one month apart from ultrasound
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 10 Jul 2012.
- Derived from this study: PubMed 23675433Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
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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.
Hao-Chien Wang, MD, PhD principal investigator
National Taiwan University Hospital, Internal Medicine
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 Apnea, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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 10 Jul 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 Taiwan. 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?
apnea-hypopnea index (time frame: less than one month apart from ultrasound). 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 NCT00674076, which also lists 1 linked publication.
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 10 Jul 2012.