The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

COPD & OSA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914264
• Other study ID #: 972246B
• Status: Completed
• Start date: December 2008
• Est. completion date: December 2016

Study information

• Verified date: August 2010
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD & OSA
• Sleep Apnea, Obstructive

Intervention

Device:
• continuous positive airway pressure
CPAP with adequate pressure for 1 day, 3 & 12 months

Locations

Country	Name	City	State
Taiwan	Division of Thoracic Medicine, Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	autonomic nerve activity	the same reason as above	3 days, 3 & 12 months
Secondary	mortality and acute exacerbation		1, 5, 10 years