None listed
Conditions
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.
Interventions
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
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.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
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.
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.
Outcome results
None listed