Long Term Prognosis of Taiwanese Patients With OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Long Term Prognosis of Taiwanese Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02090023
• Other study ID #: 201309084RIND
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2014
• Last updated: March 16, 2014
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2014
• Source: National Taiwan University Hospital
• Contact: Ming-Tzer Lin, M.D.
• Phone: +886-981-134-799
• Email: lightpool2010[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Taiwan	Center of Sleep Disorder	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or Major adverse cardiovascular events(MACEs)	MACEs 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).	from 2000 to 2013, up to 13 years	No
Secondary	Cardiovascular morbidity	Timing and events of new onset of hypertension, atrial fibrillation, or atrial flutter	from 2000 to 2013, up to 13 years	No
Secondary	Neurocognitive morbidity, up to 13 years	Timing and events of traffic accident, new onset of depression, or dementia, or epilepsy.	from 2000 to 2013, up to 13 years	No
Secondary	Metabolic morbidity	Timing and events of incident diabetics or diabetic complications or new onset of dyslipidemia.	from 2000 to 2013, up to 13 years	No
Secondary	Other morbidity	Incidence of malignancy or chronic kidney disease.	from 2000 to 2013, up to 13 years	No