Clinical trial NCT00914264: The Effects of Continuous Positive Airway Pressure on Overlap Syndrome
Official title: The Continuous Positive Airway Pressure Effects on Chronic Obstructive Pulmonary Disease Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD & OSA
Keywords: chronic obstructive airway disease
obstructive sleep apnea
continuous positive airway pressure
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: from outpatient clinic of CGMH and those in COPD cohort

Brief summary: 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.

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

Eligibility 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

Primary outcomes:
measure: exercise performance
timeFrame: 3 days, 3 & 12 months
Secondary outcomes:
measure: autonomic nerve activity
timeFrame: 3 days, 3 & 12 months
measure: mortality and acute exacerbation
timeFrame: 1, 5, 10 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
name: Yu-Lun Lo, MD
role: STUDY_DIRECTOR
affiliation: Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
name: Tsai-Yu Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
name: Han-Pin Kuo, MD,PHD
role: STUDY_CHAIR
References:
citation: Wang TY, Lo YL, Lee KY, Liu WT, Lin SM, Lin TY, Ni YL, Wang CY, Ho SC, Kuo HP. Nocturnal CPAP improves walking capacity in COPD patients with obstructive sleep apnoea. Respir Res. 2013 Jun 19;14(1):66. doi: 10.1186/1465-9921-14-66.