The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

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: Completed
• Conditions: COPD & OSA
• Intervention / Treatment: Device: continuous positive airway pressure

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
exercise performance	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

Outcome Measure	Measure Description	Time Frame
autonomic nerve activity	the same reason as above	3 days, 3 & 12 months
mortality and acute exacerbation		1, 5, 10 years

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 2, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; continuous positive airway pressure; chronic obstructive airway disease
• Other Study ID Numbers: 972246B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO