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

NCT05857475 | Completed

• 1 other identifier: MahidolU 4564
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD; OSA; Lung Function Decreased

Keywords

COPD-OSA overlap syndrome; Pulmonary function test

Outcome Measures

Primary Outcomes (1)

• 6 minute walking test distance

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

  2 months

Secondary Outcomes (8)

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

  2 months

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

  2 months

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

  2 months

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

  2 months

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

  2 months

Study Arms (2)

CPAP therapy

EXPERIMENTAL

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

Device: CPAP therapy

Control

OTHER

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.)

Other: Control

Interventions

CPAP therapy DEVICE

Continous positive airway pressure therapy

CPAP therapy

Control OTHER

No CPAP

Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis with \> 50% of central sleep apnea event
• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: May 12, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

TH (1)