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

Study Overview

• Status: Completed
• Conditions: OSA; COPD; Lung Function Decreased
• Intervention / Treatment: Device: CPAP therapy; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Faculty of Medicine Ramathibodi Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP therapy; CPAP therapy will be used in this arm for 2 month.	Device: CPAP therapy; Continous positive airway pressure therapy
Other: Control; 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; No CPAP

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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pulmonary function test; COPD-OSA overlap syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: MahidolU 4564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No