NCT02090023

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

3.9 years

First QC Date

March 16, 2014

Last Update Submit

March 16, 2014

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaNational Health Insurance Research Database in TaiwanSurvival AnalysisValidation StudiesCohort Studies

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Cardiovascular morbidity

    from 2000 to 2013, up to 13 years

  • Neurocognitive morbidity, up to 13 years

    from 2000 to 2013, up to 13 years

  • Metabolic morbidity

    from 2000 to 2013, up to 13 years

  • Other morbidity

    from 2000 to 2013, up to 13 years

Study Arms (2)

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • patients refusing to anticipate our study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Sleep Disorder

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Peilin Lee, Ph.D.

    National Taiwan University Hospital, Center of Sleep Disorders

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Tzer Lin, M.D.

CONTACT

+886-981-134-799lightpool2010@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2014

First Posted

March 18, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

TW(1)