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

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ClinicalTrials.gov Identifier: NCT00302614
Recruitment Status : Unknown
Verified December 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 14, 2006
Last Update Posted : March 14, 2006
Sponsor:
Information provided by:
National Taiwan University Hospital

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

Condition or disease
Obstructive Sleep Apnea Snoring

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.


Study Type : Observational
Enrollment : 100 participants
Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Study Start Date : January 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obstructive sleep apnea or snoring patients

Exclusion Criteria:

  • Patients with any concurrent medical illnesses except hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302614


Contacts
Contact: Ching-Ting Tan, MD, PhD 886-2-23123456 ext 5222 christin@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ching-Ting Tan, MD, PhD National Taiwan University Hospital

ClinicalTrials.gov Identifier: NCT00302614     History of Changes
Other Study ID Numbers: 9461701256
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: March 14, 2006
Last Verified: December 2005

Keywords provided by National Taiwan University Hospital:
obstructive sleep apnea
snoring
collapsibility
upper airway

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Snoring
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds