The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

NCT00914264 | Completed DMC

• 1 other identifier: 972246B
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

COPD & OSA

Keywords

chronic obstructive airway disease; obstructive sleep apnea; continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• autonomic nerve activity

  3 days, 3 & 12 months

• mortality and acute exacerbation

  1, 5, 10 years

Study Arms (3)

COPD with OSA with CPAP treatment

COPD with OSA: CPAP treatment

Device: continuous positive airway pressure

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

Interventions

continuous positive airway pressure DEVICE

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

COPD with OSA with CPAP treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

from outpatient clinic of CGMH and those in COPD cohort

You may qualify if:

• chronic stable COPD
• FEV1/FVC \< 70%
• No response to beta-agonist
• without acute exacerbation within2 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Division of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 23782492 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Yu-Lun Lo, MD

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

  STUDY DIRECTOR

• Tsai-Yu Wang, MD

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

  PRINCIPAL INVESTIGATOR

• Han-Pin Kuo, MD,PHD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: December 1, 2008
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 18, 2018

Record last verified: 2010-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)