The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

This study is currently recruiting participants.
Verified August 2010 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00914264
First received: June 2, 2009
Last updated: February 27, 2013
Last verified: August 2010
  Purpose
  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.

Condition Intervention Phase
COPD & OSA
Device: continuous positive airway pressure
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Continuous Positive Airway Pressure Effects on Chronic Obstructive Pulmonary Disease Patients With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • exercise performance [ Time Frame: 3 days, 3 & 12 months ] [ Designated as safety issue: No ]
    the condition of COPD patient will be disturbed by season factor 12 months follow up will be better than 18 months


Secondary Outcome Measures:
  • autonomic nerve activity [ Time Frame: 3 days, 3 & 12 months ] [ Designated as safety issue: No ]
    the same reason as above

  • mortality and acute exacerbation [ Time Frame: 1, 5, 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

from outpatient clinic of CGMH and those in COPD cohort

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914264

Contacts
Contact: Tsai-Yu Wang, MD 886-3-3281200 ext 8468 wang5531@gmail.com
Contact: Yu-Lun Lo, MD 886-3-3281200 ext 8467 loyulun@hotmail.com

Locations
Taiwan
Division of Thoracic Medicine, Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 105
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00914264     History of Changes
Other Study ID Numbers: 972246B
Study First Received: June 2, 2009
Last Updated: February 27, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
chronic obstructive airway disease
obstructive sleep apnea
continuous positive airway pressure

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014