The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

July 17, 2018 updated by: Chang Gung Memorial Hospital

The Continuous Positive Airway Pressure Effects on Chronic Obstructive Pulmonary Disease Patients With Obstructive Sleep Apnea

  1. The first objective of this study is to determine the differences between, while the airway obstruction severity is the same, and the acute continuous positive airway pressure (CPAP) effect on chronic obstructive pulmonary disease (COPD) patients with overlap syndrome compared with COPD patients without in terms of sleep quality, autonomic nerve activity, biologic markers of systemic inflammatory, and exercise performance.
  2. The second objective of this study is to evaluate the subacute (3 months treatment) CPAP effect on COPD patients with overlap syndrome in terms of pulmonary hemodynamic and right heart function, We will also determine the subacute effect of CPAP on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, as well as exercise performance.
  3. The last objective of this study is to evaluate the long term (12 months treatment) CPAP effect on COPD patients with overlap syndrome. The un-scheduled clinic or emergency department visiting, hospitalization, or mortality will be recorded to see if there is significant treatment effect in terms of reducing morbidity and mortality. The long term CPAP effect on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, exercise performance, as well as pulmonary hemodynamic and right heart function will be re-evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

COPD patients will be disturbed by season 12 months follow up is better than 18 months

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 105
        • Division of Thoracic Medicine, Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

from outpatient clinic of CGMH and those in COPD cohort

Description

Inclusion Criteria:

  • chronic stable COPD
  • FEV1/FVC < 70%
  • No response to beta-agonist
  • without acute exacerbation within2 months

Exclusion Criteria:

  • Chronic respiratory failure (PaO2<60 mmHg, PaCO2>50 mmHg)
  • Clinical evidence of congestive heart failure
  • Facial defect and all the other condition that can't tolerate nasal mask
  • Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
COPD with OSA with CPAP treatment
COPD with OSA: CPAP treatment
Device: continuous positive airway pressure
CPAP with adequate pressure for 1 day, 3 & 12 months
COPD without OSA
COPD without OSA, not treat with CPAP
COPD with OSA but without CPAP treatment
COPD with OSA but patient refused CPAP treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
exercise performance
Time Frame: 3 days, 3 & 12 months
the condition of COPD patient will be disturbed by season factor 12 months follow up will be better than 18 months
3 days, 3 & 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
autonomic nerve activity
Time Frame: 3 days, 3 & 12 months
the same reason as above
3 days, 3 & 12 months
mortality and acute exacerbation
Time Frame: 1, 5, 10 years
1, 5, 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yu-Lun Lo, MD, Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
  • Principal Investigator: Tsai-Yu Wang, MD, Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
  • Study Chair: Han-Pin Kuo, MD,PHD, Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 972246B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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