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

NCT ID: NCT05857475

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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COPD OSA Lung Function Decreased

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP therapy

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

Group Type EXPERIMENTAL

CPAP therapy

Intervention Type DEVICE

Continous positive airway pressure therapy

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.)

Group Type OTHER

Control

Intervention Type OTHER

No CPAP

Interventions

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CPAP therapy

Continous positive airway pressure therapy

Intervention Type DEVICE

Control

No CPAP

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MahidolU 4564

Identifier Type: -

Identifier Source: org_study_id

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