The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

NCT ID: NCT00914264

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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

Conditions

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COPD & OSA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD with OSA with CPAP treatment

COPD with OSA: CPAP treatment

continuous positive airway pressure

Intervention Type DEVICE

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

COPD without OSA

COPD without OSA, not treat with CPAP

No interventions assigned to this group

COPD with OSA but without CPAP treatment

COPD with OSA but patient refused CPAP treatment

No interventions assigned to this group

Interventions

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continuous positive airway pressure

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Lun Lo, MD

Role: STUDY_DIRECTOR

Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

Tsai-Yu Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

Han-Pin Kuo, MD,PHD

Role: STUDY_CHAIR

Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

Locations

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Division of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 23782492 (View on PubMed)

Other Identifiers

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972246B

Identifier Type: -

Identifier Source: org_study_id

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