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Completed

NCT Number: NCT00914264

The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Device

CPAP with adequate pressure for 1 day, 3 & 12 months

Primary outcomes

  1. 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

Secondary outcomes

  1. autonomic nerve activity

    Time frame: 3 days, 3 & 12 months

    the same reason as above

  2. mortality and acute exacerbation

    Time frame: 1, 5, 10 years

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2009
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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