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

Impact of sleep disturbances, circadian rhythm, comorbidities and medication in subjects with chronic obstructive pulmonary disease (COPD).

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000993594
Enrollment
100
Registered
2015-09-22
Start date
2015-10-05
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic obstructive pulmonary disease (COPD) is characterised by airflow obstruction that is incompletely reversible by short acting bronchodilators, which causes typical symptoms of breathelessness on exertion, cough, sputum production and sometimes wheeze. Nocturnal symptoms can also occur, which may be related directly to the severity of airflow obstruction but there may be other factors that affect sleep quality such as upper airway obstruction, obesity, medications, genetic variability and systemic inflammation. There has been little published work on sleep abnormalities in COPD, but sleep related symptoms in COPD appear to be common. Research questions and hypotheses In this project, we address the questions of how prevalent and what is the nature of sleep disturbance in COPD? We also propose the answer the question of how the sleep disturbances relate to changes in lung function, systemic and airway inflammation, genetic variations, activity levels and day-to-day variations in spirometry. Hypotheses Sleep disturbance in COPD is due to overnight changes in lung function, and associated with subjective overnight and early morning symptoms and worse quality of life. Our secondary hypotheses are that overnight changes in lung function are related to airway and systemic inflammation, and variations in genes that influence circadian variation. The significance of the findings will be increased understanding of the prevalence and mechanisms of sleep disturbance and symptoms in COPD. This may influence management of COPD in terms of physical and pharmacological treatment.

Interventions

This is an observational study of evening and nocturnal respiratory symptoms and their relationship with changes in lung function in moderate to severe COPD. Patients with COPD will be recruited and studied in a single afternoon and overnight session at the Woolcock Institute of Medical research. Subjects will arrive at 4:00 pm and will provide written informed consent and complete a standard Woolcock clinical questionnaire on symptoms, medication use, medical history and smoking history in the

This is an observational study of evening and nocturnal respiratory symptoms and their relationship with changes in lung function in moderate to severe COPD. Patients with COPD will be recruited and studied in a single afternoon and overnight session at the Woolcock Institute of Medical research. Subjects will arrive at 4:00 pm and will provide written informed consent and complete a standard Woolcock clinical questionnaire on symptoms, medication use, medical history and smoking history in the afternoon. They will then undergo lung function tests (FEV1, FVC, DLCO and measures of respiratory resistance and reactance). Following this blood will be drawn for measuring inflammatory markers (neutrophils and eosinophills) and clock genes (genes associated with circadian variation). This will be followed by a standard-in lab diagnostic sleep study to determine the prevalence of obstructive sleep apnea (OSA) in COPD. The following morning, subjects will have lung function measures repeated and complete a Nighttime Symptoms of COPD Instrument (NiSCI) and Early Morning Symptoms of COPD Instrument (EMSCI) questionnaire. Subjects will then be issued an Actigraphy device and portable electronic spirometer for home monitoring for 2 weeks. Subjects will be taught how to use the spirometer and will record measurements each morning. Subjects will also complete a daily symptoms diary detailing the frequency and severity of symptoms for that day and will leave the Woolcock clinic by 9:00 am. The actigraph will record the levels of activity for 2 weeks continuously for later data download. These will be collected from them at the Woolcock Laboratory, after 2 weeks.

Sponsors

A/Prof Gregory King
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026