Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000993594
Ethics application status
Not yet submitted
Date submitted
27/08/2015
Date registered
22/09/2015
Date last updated
22/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevalence and nature of sleep disturbances in subjects with chronic obstructive pulmonary disease (COPD).
Scientific title
Impact of sleep disturbances, circadian rhythm, comorbidities and medication in subjects with chronic obstructive pulmonary disease (COPD).
Secondary ID [1] 287361 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 296031 0
Sleep disorders 296101 0
Condition category
Condition code
Respiratory 296306 296306 0 0
Chronic obstructive pulmonary disease
Respiratory 296307 296307 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 292701 0
Not applicable
Comparator / control treatment
No comparator/ control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295958 0
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
Timepoint [1] 295958 0
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.
Primary outcome [2] 296006 0
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).

Timepoint [2] 296006 0
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.
Secondary outcome [1] 317041 0
One of the secondary outcomes will be associations of respiratory symptoms (cough, chest tightness, shortness of breath) determined from the questionnaire and overnight changes in spirometry (FEV1) with medication usage in COPD patients.
Timepoint [1] 317041 0
This data will be collected from first session the patients visit the Woolcock clinic and over the period of 2 weeks when they will be issued a portable spirometer and a symptom diary.
Secondary outcome [2] 317217 0
The other secondary outcome include association between sleep disturbances (diagnosed will polysomnography) and variations in ‘clock genes’ (which will me measured from the blood drawn from the patients).
Timepoint [2] 317217 0
This data will be collected during a single afternoon session where the blood will drawn and an over night sleep study in COPD patients. 18 months will be required to recruit and collect data in the entire study population.
Secondary outcome [3] 317218 0
To determine the relationship between sleep disturbances (diagnosed with polysomnography) and systemic and pulmonary inflammation (inflammatory markers will be measured from the blood drawn from each patient) .
Timepoint [3] 317218 0
This data will be collected during a single afternoon session where the blood will drawn and an over night sleep study in COPD patients. 18 months will be required to recruit and collect data in the entire study population.
Secondary outcome [4] 317399 0
The other secondary outcome include association between sleep disturbances (diagnosed will polysomnography) and activity levels (measured using actigraph watches issued to each subject) will be determined.
Timepoint [4] 317399 0
This data will be collected from over night sleep study and the period of 2 weeks when they will be issued a portable spirometer and a symptom diary.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291918 0
Commercial sector/Industry
Name [1] 291918 0
Menarini
Country [1] 291918 0
Australia
Primary sponsor type
Individual
Name
A/Prof Gregory King
Address
Department of Respiratory Medicine
Royal North Shore Hospital
Pacific Highway
St Leonards 2065, NSW
Country
Australia
Secondary sponsor category [1] 290587 0
Other
Name [1] 290587 0
Woolcock Institute of Medical Research
Address [1] 290587 0
431 Glebe point road, Glebe
NSW, 2037
Country [1] 290587 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293424 0
Belberry Limited
Ethics committee address [1] 293424 0
Ethics committee country [1] 293424 0
Australia
Date submitted for ethics approval [1] 293424 0
18/09/2015
Approval date [1] 293424 0
Ethics approval number [1] 293424 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59882 0
A/Prof Greg King
Address 59882 0
Department of Respiratory Medicine
Royal North Shore Hospital
Pacific Highway
St Leonards, NSW, 2065
Country 59882 0
Australia
Phone 59882 0
+61 2 9463 2935
Fax 59882 0
Email 59882 0
[email protected]
Contact person for public queries
Name 59883 0
Kanika Jetmalani
Address 59883 0
The Woolcock Institute of Medical Research
431 Glebe point road, Glebe, NSW, 2037
Country 59883 0
Australia
Phone 59883 0
+61 2 91140147
Fax 59883 0
Email 59883 0
[email protected]
Contact person for scientific queries
Name 59884 0
Greg King
Address 59884 0
Department of Respiratory Medicine
Royal North Shore Hospital
Pacific Highway
St Leonards, NSW, 2065
Country 59884 0
Australia
Phone 59884 0
+61 2 9463 2935
Fax 59884 0
Email 59884 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.