A prospective observational study assessing the impact of positive airway pressure therapy in patients with chronic obstructive pulmonary disease and obstructive sleep apnoea (overlap syndrome).

Not Applicable

Recruiting

• Conditions: Chronic obstructive pulmonary disease; Obstructive sleep apnoea; Cardiac remodeling; Cardiovascular disease; Cognitive impairment; Respiratory - Chronic obstructive pulmonary disease; Respiratory - Sleep apnoea; Cardiovascular - Other cardiovascular diseases; Neurological - Other neurological disorders

• Registration Number: ACTRN12622001074785
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-03
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Participants must be aged 40 years old or older.
•At least 10 pack-year smoking history.
•Spirometry demonstrating post bronchodilator FEV1/FVC less than the lower limits of normal (LLN) and FEV1 less than the LLN.
•Polysomnography (PSG) or level 2 home sleep study performed within the last 6 months of first medical visit demonstrating apnoea hypopnoea index (AHI) of equal to or greater than 30.
•Patient is not already on PAP therapy and the treating physician deems patient should start PAP therapy.

Exclusion Criteria

•Unstable patients (COPD exacerbation within last 4 weeks or myocardial infarction or stroke within the last 6 weeks)
•Neuromuscular disease.
•Sleep disorders other than OSA.
•Patients who have a contraindication to or don’t tolerate CMRI or PAP therapy.
•Moderate or greater valvular heart disease.
•Renal insufficiency with eGFR<30 ml/min/1.73m2
•Unstable Malignancy.
•History of major psychiatric disorder in the last 12 months which is likely to affect adherence to trial protocol and follow up
•Willingness to provide informed consent and willingness to participate and comply with the study requirements.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in right ventricular (RV) mass as measured by CMRI.[ Measured at baseline and three months after positive airway pressure therapy.];Changes in right ventricular remodeling index (RVRI) as measured by CMRI.[ Measured at baseline and three months after positive airway pressure therapy.];Changes in focal and diffuse myocardial fibrosis as measured by CMRI.[ Measured at baseline and three months after positive airway pressure therapy.]