Prevalence and nature of sleep disturbances in subjects with chronic obstructive pulmonary disease (COPD).

Not Applicable

• Conditions: Chronic obstructive pulmonary disease (COPD); Sleep disorders; Respiratory - Chronic obstructive pulmonary disease; Respiratory - Sleep apnoea

• Registration Number: ACTRN12615000993594
• Lead Sponsor: A/Prof Gregory King

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.A cigarette smoking history of >10 pack years.
2.Subjects will have a post-bronchodilator FEV1/FVC ratio of <0.70
3.A post-bronchodilator FEV1 of <60% of predicted (COPD-X moderate and severe disease)
4.Report symptoms of COPD (exertional breathlessness, cough, wheeze or sputum production) at least 4 days/week.

Exclusion Criteria

1.A past Dr diagnosis of asthma
2.Any other cardiac or pulmonary disease that is likely to significantly influence lung function and symptoms, e.g. heart failure, cancer, pleural disease, dementia.
3.An inability to provide written informed consent.
4.COPD exacerbation within the last 8 weeks
5.The presence of cor pulmonale
6.Use of home oxygen

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One of the primary outcome is the associations between the nature and prevalence of obstructive sleep apnea and sleep disturbances measured using polysomnography in COPD patients<br><br>[This data will be collected during a single afternoon session (where FEV1, FVC, DLCO, respiratory resistance and reactance will be measured) and an over night sleep study in COPD patients. 18 months will be required to recruit and collect data in the entire study population.];The second primary outcome is the association between sleep disturbances diagnosed using polysomnography during the sleep study and changes in FEV1 and respiratory system resistance and reactance between when they sleep and when they wake up (overnight changes). <br><br>[This data will be collected during a single afternoon session (where FEV1, FVC, DLCO, respiratory resistance and reactance will be measured) and an over night sleep study in COPD patients. 18 months will be required to recruit and collect data in the entire study population.]