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

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome

Detailed Description
-----------------
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.

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

Conditions
-----------------
OSA, COPD, Lung Function Decreased

Intervention / Treatment
-----------------
* Device: CPAP therapy
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To compare pulmonary function of COPD-OSA overlap subjects who using and not using (waiting list for PAP therapy) in the period of 2 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP therapy<br>CPAP therapy will be used in this arm for 2 month. | Device: CPAP therapy<br>* Continous positive airway pressure therapy<br>|
| Other: Control<br>CPAP therapy will not be used in this arm for 2 month. (subject were assign to normal waiting list in order to borrowing hospital PAP machine.) | Other: Control<br>* No CPAP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking test distance | To measure distance subject could walk during the period of 6 minute | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 2 months | 
| Quality of life by Sleep quality questionaires: Functional Outcomes of Sleep Questionnaire (FOSQ) | Using Functional Outcomes of Sleep Questionnaire (FOSQ) to to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. The questionaire ask about activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty) | 2 months | 
| Quality of life by Sleep quality questionaires: Epworth Sleepiness Scale (ESS) | Using Epworth Sleepiness Scale (ESS) to measure sleepiness in daily life. The ESS asks the patient to rate their likelihood of falling asleep under 8 different circumstances. | 2 months | 
| Quality of life by Sleep quality questionaires: Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score | Using Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score to guide identification of individuals at risk of sleep-disordered breathing | 2 months | 
| Aerobic capacity | Measure oxygen consumption during performing 6 minute walking test | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD-OSA overlap syndrome, Pulmonary function test