Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome

Mahidol University10 enrolled

Overview

To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome

To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome by 6 minute walking distance and oxygen consumption.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COPD OSA Lung Function Decreased

Interventions

CPAP therapyDEVICE

Continous positive airway pressure therapy

ControlOTHER

No CPAP

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis with COPD by GOLD guideline criteria (Post bronchodilator FEV1/FVC \< 0.7 or \< LLN) with post bronchodilator FEV1 = 30-80% * Diagnosis with obstructive sleep apnea with AHI \> 15 event/hr. (Moderate OSA or more) * Age between 40-80 years * Stable disease prior to inclusion. Exclusion Criteria: * Diagnosis with \> 50% of central sleep apnea event * History of COPD exacerbation during the past 8 week prior to inclusion. * Subjects who cannot perform spirometry test or walking test * Subjects with recording history of chronic heart failure, significant arrhythmias, acute myocardial infarction, moderate to severe mitral or aortic valve disease and pulmonary hypertension. * Subjects with interstitial lung disease. * Subjects with neuromuscular disease. * Subjects with morbid obesity (BMI \>/=35) * Subjects with chronic respiratory infection. * Subjects with chronic CO2 retension (PaCO2 \>/= 45 from arterial blood gas analysis) or Transcutaneous CO2 during sleep test \>/= 45 or Serum bicarbonate level \> 27 * Subjects with acute or active respiratory infecton during 2 week prior to inclusion.

Locations (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, Thailand

Outcomes

Primary Outcomes

6 minute walking test distance

To measure distance subject could walk during the period of 6 minute

Time frame: 2 months

Secondary Outcomes

Quality of life by questionaires: COPD Assessment Test (CAT)

Using COPD Assessment Test (CAT) questionaires to assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness, activities, confident, sleep and sleep) on health status \- Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life

Time frame: 2 months

Quality of life by questionaires: modified British Medical Research Council Dyspnea Scale (mMRC)

Using COPD modified British Medical Research Council Dyspnea Scale (mMRC) to assess the degree of functional disability due to dyspnea.

Time frame: 2 months

Quality of life by questionaires: St. George's Respiratory Questionnaire (SGRQ)

Using St. George's Respiratory Questionnaire (SGRQ) to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. SGRQ is divided into 2 part * Part I (Symptoms): several scales. * Part II (Activity and Impacts): dichotomous (true/false). Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame: 2 months

Quality of life by Sleep quality questionaires: Pittsburgh Sleep Quality Index (PSQI)

Using Pittsburgh Sleep Quality Index (PSQI) to assesses adult patients' sleep quality and disturbances over one month with question about Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.

Time frame: 2 months

Data from ClinicalTrials.gov

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