Clinical trial NCT02090023: Long Term Prognosis of Taiwanese Patients With OSA
Official title: Long Term Prognosis of Taiwanese Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
National Health Insurance Research Database in Taiwan
Survival Analysis
Validation Studies
Cohort Studies
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 4000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obstructive sleep apnea (PSG apnea-hypopnea index (AHI)\>5 or The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code:780.51,780.53,780.57, or 327.23) Community-based from NHIRD cohort Hospital-based from NTUH cohort

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death or Major adverse cardiovascular events(MACEs)
timeFrame: from 2000 to 2013, up to 13 years
Secondary outcomes:
measure: Cardiovascular morbidity
timeFrame: from 2000 to 2013, up to 13 years
measure: Neurocognitive morbidity, up to 13 years
timeFrame: from 2000 to 2013, up to 13 years
measure: Metabolic morbidity
timeFrame: from 2000 to 2013, up to 13 years
measure: Other morbidity
timeFrame: from 2000 to 2013, up to 13 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Center of Sleep Disorder
Study officials:
affiliation: National Taiwan University Hospital, Center of Sleep Disorders
name: Peilin Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: