Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000288426
Ethics application status
Approved
Date submitted
8/03/2007
Date registered
31/05/2007
Date last updated
4/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
OSA screening in COPD
Scientific title
The utility of a clinical algorithm for diagnosing Obstructive Sleep Apnoea (OSA) in symptomatic patients with Chronic Obstructive Pulmonary Disease (COPD)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 1829 0
Obstructive Sleep Apnoea 1830 0
Condition category
Condition code
Respiratory 1921 1921 0 0
Chronic obstructive pulmonary disease
Respiratory 1922 1922 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Questionnaires, biometric data, upper airway function (using the Forced Oscillation Technique) and lung function (using standard pre and post bronchodilator spirometry) will be administered over 30 minutes by research staff upon enrolment. Subjects will then be allocated to receive both the single channel home based sleep apnoea monitoring device (Flow Wizard, DiagnoseIT, Australia) for three nights at home and in hospital polysomnography for one night in random order. Subjects will receive both the in hospital polysomnography and home testing within a four week period. The wash out period is 24hours.
Intervention code [1] 1638 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2735 0
To establish the utility of a clinical algorithm based on questionnaires, upper airway assessment, biometrics, upper airway function (Forced Oscillation Technique), lung function and home monitoring (via a single channel device measuring nasal flow) in diagnosing for OSA in symptomatic patients with COPD.
Timepoint [1] 2735 0
Determined at the conclusion of the trial.
Secondary outcome [1] 4610 0
To establish the utility of a clinical algorithm based on questionnaires, upper airway assessment, biometrics, upper airway function (Forced Oscillation Technique), lung function and home monitoring (via a single channel device measuring nasal flow in diagnosing Obstructive Sleep Apnoea (OSA) in those with varying degrees of Chronic Obstructive Pulmonary Disease (COPD) severity according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Timepoint [1] 4610 0
This will be determined at the conclusion of the trial.
Secondary outcome [2] 4611 0
To compare the utility of a clinical algorithm based on questionnaires, upper airway assessment, biometrics, upper airway function (Forced Oscillation Technique), lung function and home monitoring (via a single channel device measuring nasal flow in diagnosing OSA in COPD in different patient subgroups for example according to sex, ethnicity, different disease groups such as cardiac etc.
Timepoint [2] 4611 0
This will be determined at the conclusion of the trial.

Eligibility
Key inclusion criteria
Group 1 (Control group): symptoms of sleep apnoea (including snoring, choking, witnessed apneas and daytime sleepiness) and/or co morbidities including obesity, hypertension and the metabolic syndrome that are non smokers with < 5 pack year history. Group 2 COPD patients who are smokers or ex smokers with > 10 pack year history of smoking and symptoms of OSA, and/or co morbidities including obesity, hypertension and the metabolic syndrome, are able to give informed consent.
Minimum age
Maximum age
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to comply with procedures, previous diagnosis of other respiratory and/or sleep disorders, and current treatment with continuous positive airways pressure, a tracheostomy or home oxygen as well as poorly controlled other medical conditions.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2067 0
Other
Name [1] 2067 0
Woolcock Institute of Medical Research
Country [1] 2067 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 1872 0
None
Name [1] 1872 0
Nil
Address [1] 1872 0
Country [1] 1872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3839 0
Sydney South West Area Health Service- Royal Prince Alfred Hospital (RPAH) Zone
Ethics committee address [1] 3839 0
Ethics committee country [1] 3839 0
Australia
Date submitted for ethics approval [1] 3839 0
Approval date [1] 3839 0
05/03/2007
Ethics approval number [1] 3839 0
X07-0003,

Summary
Brief summary
At enrolment eligibility will be confirmed. Subjects will answer questionnaires; have anthropometric measures taken and upper airway function and lung function assessed. All patients will undergo home testing with a diagnostic device for three nights and have an in laboratory sleep study in random order. All tests will be performed within a 4 week period. The results will not be communicated to the participant or the treating physicians until all components have been performed. The participants will then be referred to a sleep specialist to have the results of the polysomnogram discussed, and appropriate management instituted outside of the study, as dictated by usual clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27572 0
Address 27572 0
Country 27572 0
Phone 27572 0
Fax 27572 0
Email 27572 0
Contact person for public queries
Name 10827 0
Sarah Newton-John
Address 10827 0
Woolcock Institute of Medical Research
PO Box M77 Missenden Rd
Camperdown NSW 2050
Country 10827 0
Australia
Phone 10827 0
+61 2 95156578
Fax 10827 0
+61 2 95505865
Email 10827 0
[email protected]
Contact person for scientific queries
Name 1755 0
Dr Lydia Makarie Rofail
Address 1755 0
Woolcock Institute of Medical Research
PO Box M77 Missenden Rd
Camperdown NSW 2050
Country 1755 0
Australia
Phone 1755 0
+61 2 95157590
Fax 1755 0
+61 2 95575059
Email 1755 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.