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Obstructive Sleep ApneaNCT00302614

The Role of Clinical Parameters in Predicting the Severity of Obstructive Sleep Apnea

An observational study of Obstructive Sleep Apnea and Snoring, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Investigate the role of clinical parameters in predicting the severity of obstructive sleep apnea Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Obstructive Sleep Apnea, Snoring
How many people
100 participants
Where
1 siteTaiwan
Study dates
Jan 2006to Jun 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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Obstructive sleep apnea or snoring patients

Who cannot join

  • Patients with any concurrent medical illnesses except hypertension

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei

    Recruiting

Other trials in Taiwan

About this study

Investigate the role of clinical parameters in predicting the severity of obstructive sleep apnea

Read the detailed description

During the last two decades the obstructive sleep apnea syndrome (OSAS) has been increasingly recognized as a distinct clinical entity. This condition is caused by recurrent upper airway obstruction during sleep, is manifest as loud snoring, arterial oxygen desaturation, sleep fragmentation, and excessive daytime sleepiness1,2. Epidemiological series have shown that about 4% of the population suffers from symptomatic OSAS that requires treatment3-5. OSAS is associated with increased rates of many chronic diseases6,7 and is a serious and potentially life-threatening disorder that is far more common than generally believed. Thus, untreated OSAS may pose a significant public health problem8. Epidemiological data demonstrating the relationship between OSAS and cardiovascular morbidity highlight the potential importance of early recognition and treatment9.

The mechanisms responsible for upper airway obstruction in patients with OSAS are highly complicated and as yet not fully understood. Several causes for OSAS have been suggested. It appears to result from a variable combination of anatomic and pathophysiologic factors, some of which may be under genetic control10. The relaxation of upper airway musculature has been studied in relation to OSAS11-13. Anatomic narrowing of the upper airway as a result of alterations in craniofacial morphology or soft tissue enlargement, the Bernoulli effect, sleep posture, age, male gender, and adipose tissue in the pharynx have been suggested in the etiology of OSAS14-17.

Several studies have suggested that ethnicity may be an important risk factor in OSAS17-20. Recent reports have suggested that Asian subjects with OSAS have a greater severity of illness compared with white subjects21,22. Some studies reported that obesity is the strongest risk factor for OSAS in middle-aged adults3,23,24. However, we have treated many non-obese Taiwanese young adults with severe OSAS. Previous researches have suggested that there may be differences in obesity and craniofacial anatomy as risk factors between Asians and whites25 and that the etiology of OSAS in obese patients may be different from that in non-obese patients16,26,27. It is still unclear whether there are differences in clinical evaluation parameters between non-obese Asian patients with severe OSAS and simple snoring.

We hypothesized that there are predictor factors in routine clinical examinations for diagnosis of OSAS in non-obese young adult patients. Therefore, the objectives of this study are to compare the clinical parameters in non-obese patients with severe OSAS with those of simple snorers and to find the risk factors for OSAS in a non-obese young adult Taiwanese population.

Keywords
obstructive sleep apnea, snoring, collapsibility, upper airway
Medical subject headings
Sleep Apnea, Obstructive, Snoring

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2006 (estimated)
  2. Study startJan 2006
  3. Study completionJun 2006

Resources

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
Natural history
Time perspective
Retrospective
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00302614
Sponsor's protocol ID
9461701256
Status last verified
Dec 2005
First submitted
12 Mar 2006
Last updated
14 Mar 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea and Snoring, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Mar 2006. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ching-Ting Tan, MD, PhD (886-2-23123456 ext. 5222, christin@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
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 14 Mar 2006.

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Clinical Trial NCT00302614 | AzTrials