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Long Term Prognosis of Taiwanese Patients With OSA

Long Term Prognosis of Taiwanese Patients With Obstructive Sleep Apnea

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02090023
Enrollment
4000
Registered
2014-03-18
Start date
2014-01-31
Completion date
2017-12-31
Last updated
2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea, National Health Insurance Research Database in Taiwan, Survival Analysis, Validation Studies, Cohort Studies

Brief summary

The purpose of this study is to explore long-term prognosis and to identify the predictors in Taiwanese OSA patients. Validation of the prediction model derived from NHIRD with the database of National Taiwan University Hospital (NTUH) sleep center is planed to determine the effects of different treatments on long-term prognosis.

Detailed description

Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent hypoxia and sleep fragmentation. OSA is associated with cardiovascular morbidity and mortality, metabolic dysregulation, and neurocognitive dysfunction, which may bring worse prognosis. Continuous positive airway pressure (CPAP) is the standard treatment of OSA while the oral appliance and surgery are the alternative treatments. The differences of craniofacial features among races contributed to the race-specific presentations of OSA. Up to date, only limited studies investigated the long-term prognosis of OSA and most of them recruited Caucasians and African Americans. Moreover, most studies didn't address the impact of treatment other than CPAP on the long-term prognosis. . National Health Insurance Research Database (NHIRD) in Taiwan enrolled 99% of whole Taiwan's population and has longer period of 10 years for follow-up, which is suitable for investigation of long-term prognosis and predictors in OSA. However, due to limited parameters for diagnosis and treatment, the results could be biased in such secondary database research. Center of Sleep Disorder in National Taiwan University Hospital (NTUH) established from 2006 has 2,600 sleep studies annually. Therefore, database and cohort from sleep center could offer the validations of the prognosis and predictors determined from NHIRD. In addition, the impact of all three treatment modalities, namely CPAP, oral appliance, and surgery, on long-term prognosis could be studied in the prospective way. Therefore, in this project, we aimed to achieve three goals (1) To explore long-term prognosis and identify the predictors in Taiwanese OSA patients with NHIRD, where the prediction mode of prognosis was established (2). To validate the prediction model derived from NHIRD with the database of NTUH sleep center (3) To determine the effects of different treatments on long-term prognosis with prospective following NTUH sleep center cohort.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* NHIRD - \>=20 y/o; OSA ICD-9-CM code: 780.51,780.53,780.57, or 327.23; coexisted with PSG procedure code: 17008B,17008A. * NTUH cohort - \>=20 y/o; PSG AHI\>5

Exclusion criteria

* patients refusing to anticipate our study

Design outcomes

Primary

MeasureTime frameDescription
Death or Major adverse cardiovascular events(MACEs)from 2000 to 2013, up to 13 yearsMACEs includes cardiogenic death, ischemic stroke, myocardial injury or acute coronary syndrome requiring revascularization. Data from NHIRD (database screening retrospectively) and NTUH cohort (recallable history taking).

Secondary

MeasureTime frameDescription
Cardiovascular morbidityfrom 2000 to 2013, up to 13 yearsTiming and events of new onset of hypertension, atrial fibrillation, or atrial flutter
Neurocognitive morbidity, up to 13 yearsfrom 2000 to 2013, up to 13 yearsTiming and events of traffic accident, new onset of depression, or dementia, or epilepsy.
Metabolic morbidityfrom 2000 to 2013, up to 13 yearsTiming and events of incident diabetics or diabetic complications or new onset of dyslipidemia.
Other morbidityfrom 2000 to 2013, up to 13 yearsIncidence of malignancy or chronic kidney disease.

Countries

Taiwan

Contacts

Primary ContactMing-Tzer Lin, M.D.
lightpool2010@gmail.com+886-981-134-799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026