Obstructive Sleep ApneaNCT02090023
Long Term Prognosis of Taiwanese Patients With OSA
An observational study of Obstructive Sleep Apnea, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 4,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- patients refusing to anticipate our study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Center of Sleep Disorder
Taipei, 110
Peilin Lee, Ph.D., +886-2-356-2755, sleepcenter@ntuh.gov.tw
About this study
Official title: Long Term Prognosis of Taiwanese Patients With Obstructive Sleep Apnea
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, National Health Insurance Research Database in Taiwan, Survival Analysis, Validation Studies, Cohort Studies
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NHIRD obstructive sleep apnea | Secondary database from community-based National Health Insurance Research Database | |
| NTUH obstructive sleep apnea cohort | Primary database from enrollment of retrospective NTUH hospital-based cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from 2000 to 2013, up to 13 years
Secondary outcomes (4)
Cardiovascular morbidity
Timing and events of new onset of hypertension, atrial fibrillation, or atrial flutter
Measured: from 2000 to 2013, up to 13 years
Neurocognitive morbidity, up to 13 years
Timing and events of traffic accident, new onset of depression, or dementia, or epilepsy.
Measured: from 2000 to 2013, up to 13 years
Metabolic morbidity
Timing and events of incident diabetics or diabetic complications or new onset of dyslipidemia.
Measured: from 2000 to 2013, up to 13 years
Other morbidity
Incidence of malignancy or chronic kidney disease.
Measured: from 2000 to 2013, up to 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peilin Lee, Ph.D., Principal investigator, National Taiwan University Hospital, Center of Sleep Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090023
- Sponsor's protocol ID
- 201309084RIND
- Status last verified
- Mar 2014
- First submitted
- 16 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Prognosis of Taiwanese Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02090023
- Acronym / sponsor ID
- 201309084RIND
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, National Health Insurance Research Database in Taiwan, Survival Analysis, Validation Studies, Cohort Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NHIRD obstructive sleep apnea | – | –Secondary database from community-based National Health Insurance Research Database |
| NTUH obstructive sleep apnea cohort | – | –Primary database from enrollment of retrospective NTUH hospital-based cohort |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- patients refusing to anticipate our study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death or Major adverse cardiovascular events(MACEs)
Time frame: from 2000 to 2013, up to 13 years
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).
4 secondary outcomes
Cardiovascular morbidity
Time frame: from 2000 to 2013, up to 13 years
Neurocognitive morbidity, up to 13 years
Time frame: from 2000 to 2013, up to 13 years
Metabolic morbidity
Time frame: from 2000 to 2013, up to 13 years
Other morbidity
Time frame: from 2000 to 2013, up to 13 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peilin Lee, Ph.D. principal investigator
National Taiwan University Hospital, Center of Sleep Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, 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 2 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 18 Mar 2014. 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 Ming-Tzer Lin, M.D. (+886-981-134-799, lightpool2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or Major adverse cardiovascular events(MACEs) (time frame: from 2000 to 2013, up to 13 years). It is what the study was designed to measure, not a finding.
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 18 Mar 2014.