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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857475
• Other study ID #: MahidolU 4564
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Lung Function Decreased
• OSA
• Syndrome

Intervention

Device:
• CPAP therapy
Continous positive airway pressure therapy

Other:
• Control
No CPAP

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walking test distance	To measure distance subject could walk during the period of 6 minute	2 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Aerobic capacity	Measure oxygen consumption during performing 6 minute walking test	2 months