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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

CPAP therapy

Control

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD-OSA overlap syndrome, Pulmonary function test

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CPAP therapy

Control

Arm Description

CPAP therapy will be used in this arm for 2 month.

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.)

Outcomes

Primary Outcome Measures

6 minute walking test distance

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

Secondary Outcome Measures

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

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.

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.

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.

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)

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.

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

Aerobic capacity

Measure oxygen consumption during performing 6 minute walking test

Full Information

NCT ID

NCT05857475

First Posted

March 3, 2023

Last Updated

May 4, 2023

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT05857475

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2023 (Anticipated)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

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

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, OSA, Lung Function Decreased

Keywords

COPD-OSA overlap syndrome, Pulmonary function test

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CPAP therapy

Arm Type

Experimental

Arm Description

CPAP therapy will be used in this arm for 2 month.

Arm Title

Control

Arm Type

Other

Arm Description

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.)

Intervention Type

Device

Intervention Name(s)

CPAP therapy

Intervention Description

Continous positive airway pressure therapy

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

No CPAP

Primary Outcome Measure Information:

Title

6 minute walking test distance

Description

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

Time Frame

2 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 months

Title

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

Description

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

Time Frame

2 months

Title

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

Description

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.

Time Frame

2 months

Title

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

Description

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.

Time Frame

2 months

Title

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

Description

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)

Time Frame

2 months

Title

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

Description

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.

Time Frame

2 months

Title

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

Description

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

Time Frame

2 months

Title

Aerobic capacity

Description

Measure oxygen consumption during performing 6 minute walking test

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pitirat Panpruang

Phone

+6684-9023579

Email

ptontan@hotmail.com

Facility Information:

Facility Name

Faculty of Medicine Ramathibodi Hospital, Mahidol University

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Human Research Ethics Committee

Phone

(660)2012175

Email

raec.mahidol@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

COPD, OSA, Lung Function Decreased

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial