Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05857475
Enrollment
10
Registered
2023-05-12
Start date
2023-06-01
Completion date
2024-01-01
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, OSA, Lung Function Decreased

Keywords

COPD-OSA overlap syndrome, Pulmonary function test

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.

Interventions

Continous positive airway pressure therapy

OTHERControl

No CPAP

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
6 minute walking test distance2 monthsTo measure distance subject could walk during the period of 6 minute

Secondary

MeasureTime frameDescription
Quality of life by questionaires: modified British Medical Research Council Dyspnea Scale (mMRC)2 monthsUsing COPD modified British Medical Research Council Dyspnea Scale (mMRC) to assess the degree of functional disability due to dyspnea.
Quality of life by questionaires: St. George's Respiratory Questionnaire (SGRQ)2 monthsUsing 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.
Quality of life by Sleep quality questionaires: Pittsburgh Sleep Quality Index (PSQI)2 monthsUsing 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.
Quality of life by questionaires: COPD Assessment Test (CAT)2 monthsUsing 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
Quality of life by Sleep quality questionaires: Epworth Sleepiness Scale (ESS)2 monthsUsing 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.
Quality of life by Sleep quality questionaires: Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score2 monthsUsing Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score to guide identification of individuals at risk of sleep-disordered breathing
Aerobic capacity2 monthsMeasure oxygen consumption during performing 6 minute walking test
Quality of life by Sleep quality questionaires: Functional Outcomes of Sleep Questionnaire (FOSQ)2 monthsUsing 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)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026