Trial registered on ANZCTR


Trial ID
ACTRN12608000514303
Ethics application status
Approved
Date submitted
9/09/2008
Date registered
2/10/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Simplified Management of Obstructive Sleep Apnea in General Practice
Scientific title
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
Secondary ID [1] 711 0
426744 National Health and Medical Research Council
Universal Trial Number (UTN)
Trial acronym
SMOSA2

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 3658 0
Condition category
Condition code
Respiratory 3825 3825 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 3373 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 4726 0
Epworth sleepiness scale
Timepoint [1] 4726 0
baseline, 3 and 6 months
Secondary outcome [1] 7973 0
Functional Outcomes of Sleep Questionnaire to assess the impact of sleepiness on multiple activities of daily living.
Timepoint [1] 7973 0
baseline, 3 and 6 months
Secondary outcome [2] 7974 0
SF36 questionnaire to assess patients views about their health status
Timepoint [2] 7974 0
baseline, 3 and 6 months
Secondary outcome [3] 7975 0
Sleep Apnea Symptoms Questionnaire (SASQ), eg snoring, daytime sleepiness, morning headaches, libido, witnessed apneas
Timepoint [3] 7975 0
baseline, 3 and 6 months
Secondary outcome [4] 7976 0
Patient satisfaction survey
Timepoint [4] 7976 0
6 months
Secondary outcome [5] 7977 0
Health utilisation and costs using Medical Benefits Scheme and Pharmaceutical Benefits Scheme data from Medicare, and patient's self-report regarding hospital admissions.
Timepoint [5] 7977 0
6 months
Secondary outcome [6] 7978 0
CPAP compliance - objective data to be downloaded from the CPAP device
Timepoint [6] 7978 0
baseline, 3 months, 6 months
Secondary outcome [7] 7979 0
Blood pressure
Timepoint [7] 7979 0
baseline, 3 and 6 months

Eligibility
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
Minimum age
25 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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%)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software to generate a random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/10/2008
Actual date of first participant enrolment
3/11/2008
Anticipated date last participant enrolled
Actual date last participant enrolled
20/09/2010
Anticipated date of last data collection
Actual date of last data collection
Target sample size
250
Actual sample size
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1132 0
5159
Recruitment postcode(s) [2] 1133 0
5052
Recruitment postcode(s) [3] 1134 0
5165
Recruitment postcode(s) [4] 1135 0
5244
Recruitment postcode(s) [5] 1136 0
5214
Recruitment postcode(s) [6] 1137 0
5211
Recruitment postcode(s) [7] 1138 0
5345
Recruitment postcode(s) [8] 1139 0
5333
Recruitment postcode(s) [9] 1140 0
5341
Recruitment postcode(s) [10] 1141 0
5343
Recruitment postcode(s) [11] 1142 0
5330

Funding & Sponsors
Funding source category [1] 3839 0
Government body
Name [1] 3839 0
National Health and Medical Research Council
Address [1] 3839 0
GPO Box 1421
Canberra ACT 2601
Country [1] 3839 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 3450 0
Commercial sector/Industry
Name [1] 3450 0
ResMed Ltd
Address [1] 3450 0
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153
Country [1] 3450 0
Australia
Secondary sponsor category [2] 3451 0
Commercial sector/Industry
Name [2] 3451 0
Respironics Australia Pty Ltd
Address [2] 3451 0
Unit 7/ 11 Lord St
Botany NSW 2019
Country [2] 3451 0
Australia
Secondary sponsor category [3] 3452 0
Commercial sector/Industry
Name [3] 3452 0
SomnoMed Ltd
Address [3] 3452 0
Level 3/ 20 Clarke St
Crows Nest NSW 1582
Country [3] 3452 0
Australia
Other collaborator category [1] 404 0
Other Collaborative groups
Name [1] 404 0
Southern Division of General Practice
Address [1] 404 0
Level 3A, 5 Laffer Drive
Sir Mark Oliphant Building
Bedford Park SA 5042
Country [1] 404 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5893 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 5893 0
Repatriation General Hospital
206-216 Daws Road
Daw Park SA 5041
Ethics committee country [1] 5893 0
Australia
Date submitted for ethics approval [1] 5893 0
Approval date [1] 5893 0
15/02/2007
Ethics approval number [1] 5893 0
Ethics committee name [2] 5894 0
Flinders Clinical Research Ethics Committee
Ethics committee address [2] 5894 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Ethics committee country [2] 5894 0
Australia
Date submitted for ethics approval [2] 5894 0
Approval date [2] 5894 0
11/12/2006
Ethics approval number [2] 5894 0

Summary
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.
Trial website
Trial related presentations / publications
CL Chai-Coetzer, NA Antic, LS Rowland, RL Reed, A Esterman, PG Catcheside, S Eckermann, N Vowles, H Williams, S Dunn, RD McEvoy. Primary care vs specialist sleep center management of obstructive sleep apnea and daytime sleepiness and quality of life: a randomized trial. Journal of the American Medical Association (JAMA). 2013;309(10):997-1004
Public notes

Contacts
Principal investigator
Name 28912 0
Prof Doug McEvoy
Address 28912 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Rd, Daw Park, SA 5041
Country 28912 0
Australia
Phone 28912 0
+61882751187
Fax 28912 0
Email 28912 0
doug.mcevoy@health.sa.gov.au
Contact person for public queries
Name 12069 0
Dr Ching Li Chai
Address 12069 0
Adelaide Insititute for Sleep Health
Repatriation General Hospital
206-216 Daws Road
Daw Park SA 5041
Country 12069 0
Australia
Phone 12069 0
+61 8 8275 1187
Fax 12069 0
Email 12069 0
chingli.chai@health.sa.gov.au
Contact person for scientific queries
Name 2997 0
Prof Doug McEvoy
Address 2997 0
Adelaide Insititute for Sleep Health
Repatriation General Hospital
206-216 Daws Road
Daw Park SA 5041
Country 2997 0
Australia
Phone 2997 0
+61 8 8275 1187
Fax 2997 0
Email 2997 0
doug.mcevoy@health.sa.gov.au