Trial from ANZCTR


Trial ID ACTRN12608000514303
Trial Status: Registered
Date Submitted: 9/09/2008
Date Registered: 2/10/2008
Retrospectively registered

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Public title Simplified Management of Obstructive Sleep Apnea in General Practice
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised controlled trial to evaluate a simplified management strategy for moderate-to-severe obstructive sleep apnea comparing improvements in daytime sleepiness in patients managed in primary care (general practitioner assisted by a sleep specialist nurse) versus usual care in a sleep specialist centre
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Secondary ID [1] 711 0
426744 National Health and Medical Research Council
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UTN
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Trial acronym SMOSA2
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Health condition(s) or problem(s) studied:
Obstructive sleep apnea 3658 0
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Condition category: Condition code:
Respiratory Sleep apnoea
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3825 3825 0 0

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Descriptions of intervention(s) / exposure General practice-based management for a total of 6 months. Patients will have an auto-continuous positive airway pressure (CPAP) titration study at home over 3 nights to determine their CPAP treatment pressure. CPAP therapy will be worn by patients at night for the 6 month duration of the study and followed up by a sleep nurse based in the community at 1, 3 and 6 months and their general practitioner at 3 and 6 months. Each follow-up visit with the nurse will be of 30 minutes duration, and 15-20 minutes for general practitioner review.
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Intervention Code:
Treatment: Other 3373 0
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Comparator / control treatment Sleep specialist centre management for a total of 6 months. Patients will have a sleep laboratory-based CPAP titiration over one night to determine their required CPAP treatment pressure. CPAP therapy will then be worn by the patient at night for the 6 month duration of the study. Patients will be followed up in the hospital outpatient setting by the sleep nurse at 1, 3 and 6 months and by a sleep specialist at 3 and 6 months. Each follow-up visit with the nurse will be of 30 minutes duration, and 15-20 minutes for sleep specialist review.
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Control group Active
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Primary Outcome: Epworth sleepiness scale 4726 0
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Timepoint: baseline, 3 and 6 months 4726 0
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Secondary Outcome: Functional Outcomes of Sleep Questionnaire to assess the impact of sleepiness on multiple activities of daily living. 7973 0
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Timepoint: baseline, 3 and 6 months 7973 0
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Secondary Outcome: SF36 questionnaire to assess patients views about their health status 7974 0
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Timepoint: baseline, 3 and 6 months 7974 0
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Secondary Outcome: Sleep Apnea Symptoms Questionnaire (SASQ), eg snoring, daytime sleepiness, morning headaches, libido, witnessed apneas 7975 0
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Timepoint: baseline, 3 and 6 months 7975 0
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Secondary Outcome: Patient satisfaction survey 7976 0
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Timepoint: 6 months 7976 0
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Secondary Outcome: Health utilisation and costs using Medical Benefits Scheme and Pharmaceutical Benefits Scheme data from Medicare, and patient's self-report regarding hospital admissions. 7977 0
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Timepoint: 6 months 7977 0
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Secondary Outcome: CPAP compliance - objective data to be downloaded from the CPAP device 7978 0
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Timepoint: baseline, 3 months, 6 months 7978 0
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Secondary Outcome: Blood pressure 7979 0
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Timepoint: baseline, 3 and 6 months 7979 0
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Key inclusion criteria Moderate-to-severe obstructive sleep apnea (OSA) - positive on OSA50 screening questionnaire; Epworth sleepiness scale (ESS)>=8 or poorly-controlled hypertension despite 2 or more antihypertensive agents; ApneaLink 3% oxygen desturation index (ODI)>=16
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Minimum age 25 Years
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Maximum age 70 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Body mass index (BMI)>50
Neuromuscular disease
Significant psychiatric disease which would affect patient's ability to comply with study protocol
Cognitive disability that would prevent self management of CPAP
Recent hospitalisation for myocardial infarction (MI), unstable angina, cardiac failure, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in past 3 months, and/or New York Heart Association (NYHA) Class 3 or 4
Moderate-to-severe respiratory disease (documented hypoxia or awake oxygen saturation <92%)
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Patients attending their general practitioner (GP) for any reason will be screened for high risk of OSA using a screening questionnaire (OSA50) and Epworth sleepiness scale. Patients with OSA50 score>=5 and ESS>=8 or poorly controlled hypertension despite 2 antihypertensive agents will be eligible for inclusion. Patients will undergo a home ApneaLink study to confirm a diagnosis of moderate-to-severe OSA, defined as a 3% oxygen desaturation index >=16. Patients confirmed to have moderate-to-severe OSA will be randomised into the study. Treatment will be allocated externally via a third party (ie pharmacy telephone system).
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer software to generate a random number sequence
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 1/10/2008
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 250
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 5159 1132 0
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Postcode: 5052 1133 0
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Postcode: 5165 1134 0
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Postcode: 5244 1135 0
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Postcode: 5214 1136 0
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Postcode: 5211 1137 0
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Postcode: 5345 1138 0
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Postcode: 5333 1139 0
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Postcode: 5341 1140 0
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Postcode: 5343 1141 0
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Postcode: 5330 1142 0
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Recruitment outside Australia

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Funding Source: Government body 3839 0
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Name: National Health and Medical Research Council 3839 0
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Address: GPO Box 1421
Canberra ACT 2601
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Country: Australia 3839 0
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Primary Sponsor Government body
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Name: National Health and Medical Research Council
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Address: GPO Box 1421
Canberra ACT 2601
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Country: Australia
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Secondary Sponsor: Commercial sector/Industry 3450 0
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Name: ResMed Ltd 3450 0
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Address: 1 Elizabeth Macarthur Drive
Bella Vista NSW 2153
3450 0
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Country: Australia 3450 0
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Secondary Sponsor: Commercial sector/Industry 3451 0
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Name: Respironics Australia Pty Ltd 3451 0
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Address: Unit 7/ 11 Lord St
Botany NSW 2019
3451 0
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Country: Australia 3451 0
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Secondary Sponsor: Commercial sector/Industry 3452 0
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Name: SomnoMed Ltd 3452 0
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Address: Level 3/ 20 Clarke St
Crows Nest NSW 1582
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Country: Australia 3452 0
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Other Collaborator: Other Collaborative groups 404 0
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Name: Southern Division of General Practice 404 0
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Address: Level 3A, 5 Laffer Drive
Sir Mark Oliphant Building
Bedford Park SA 5042
404 0
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Country: Australia 404 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Repatriation General Hospital Research and Ethics Committee 5893 0
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Address: Repatriation General Hospital
206-216 Daws Road
Daw Park SA 5041
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Country: Australia 5893 0
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Approval Date: 15/02/2007 5893 0
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Submitted Date: 5893 0
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HREC: 5893 0
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Ethics Committee name: Flinders Clinical Research Ethics Committee 5894 0
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Address: Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
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Country: Australia 5894 0
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Approval Date: 11/12/2006 5894 0
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Submitted Date: 5894 0
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HREC: 5894 0
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Brief summary This study will compare health outcomes and costs for patients diagnosed with moderate to severe obstructive sleep apnea managed by either their general practitioner assisted by a sleep-trained nurse in the community or by a sleep physician in a hospital outpatient setting.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Ching Li Chai
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Address: Adelaide Insititute for Sleep Health Repatriation General Hospital 206-216 Daws Road Daw Park SA 5041
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Country: Australia
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Tel: +61 8 8275 1187
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Email: chingli.chai@health.sa.gov.au
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Contact person for scientific queries
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Name: Doug McEvoy
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Address: Adelaide Insititute for Sleep Health Repatriation General Hospital 206-216 Daws Road Daw Park SA 5041
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Country: Australia
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Email: doug.mcevoy@health.sa.gov.au
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