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Completed

NCT Number: NCT05857475

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Lung Function Decreased OSA Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP therapy

Device

Continous positive airway pressure therapy

Control

Other

No CPAP

Primary outcomes

  1. 6 minute walking test distance

    Time frame: 2 months

    To measure distance subject could walk during the period of 6 minute

Secondary outcomes

  1. Quality of life by questionaires: COPD Assessment Test (CAT)

    Time frame: 2 months

    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. Quality of life by questionaires: modified British Medical Research Council Dyspnea Scale (mMRC)

    Time frame: 2 months

    Using COPD modified British Medical Research Council Dyspnea Scale (mMRC) to assess the degree of functional disability due to dyspnea.

  3. Quality of life by questionaires: St. George's Respiratory Questionnaire (SGRQ)

    Time frame: 2 months

    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.

  4. Quality of life by Sleep quality questionaires: Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 2 months

    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.

  5. Quality of life by Sleep quality questionaires: Functional Outcomes of Sleep Questionnaire (FOSQ)

    Time frame: 2 months

    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)

  6. Quality of life by Sleep quality questionaires: Epworth Sleepiness Scale (ESS)

    Time frame: 2 months

    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.

  7. Quality of life by Sleep quality questionaires: Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score

    Time frame: 2 months

    Using Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score to guide identification of individuals at risk of sleep-disordered breathing

  8. Aerobic capacity

    Time frame: 2 months

    Measure oxygen consumption during performing 6 minute walking test

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 12, 2023
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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