Clinical trial NCT05857475: Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
Official title: Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
OSA
Lung Function Decreased
Keywords: COPD-OSA overlap syndrome
Pulmonary function test
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 6 minute walking test distance
timeFrame: 2 months
Secondary outcomes:
measure: Quality of life by questionaires: COPD Assessment Test (CAT)
timeFrame: 2 months
measure: Quality of life by questionaires: modified British Medical Research Council Dyspnea Scale (mMRC)
timeFrame: 2 months
measure: Quality of life by questionaires: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 2 months
measure: Quality of life by Sleep quality questionaires: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 months
measure: Quality of life by Sleep quality questionaires: Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 2 months
measure: Quality of life by Sleep quality questionaires: Epworth Sleepiness Scale (ESS)
timeFrame: 2 months
measure: Quality of life by Sleep quality questionaires: Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score
timeFrame: 2 months
measure: Aerobic capacity
timeFrame: 2 months
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
References: