Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000926932
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
29/08/2011
Date last updated
4/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to compare how well patients do with treatment after undergoing full monitoring in a sleep laboratory versus simplified sleep study recordings to test for possible obstructive sleep apnea
Scientific title
A randomised controlled trial to compare treatment outcomes following full polysomnography versus limited sleep study recording for suspected obstructive sleep apnea.
Secondary ID [1] 262946 0
Nil
Universal Trial Number (UTN)
Trial acronym
LIFT-OSA Study: LImited versus Full Testing for Obstructive Sleep Apnea
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 270671 0
Condition category
Condition code
Respiratory 270846 270846 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to management by their sleep physician following disclosure of sleep study information according to one of three levels of testing:
Level 1 sleep study: Full polysomnography
Level 3 sleep study: Limited sleep study, with airflow, respiratory thoraco-abdominal movement, ECG and oxygen saturation only
Level 4 sleep study: Limited sleep study, with oxygen saturation only

Following randomisation, all patients will undergo full polysomnography (PSG) testing over a single night (ie at least 6 hours) in a sleep laboratory. All information will be de-indentified and transferred to a central sleep laboratory (ie Adelaide Institute for Sleep Health), where studies will be scored using data from channels which correspond to the level of sleep study testing that the patient is randomised to, as well as their full PSG. For patients randomised to the Level 3 or 4 arms, the sleep physician will only be given results for the limited sleep study, with disclosure of the full PSG being withheld until after the 4 month follow-up period.
Intervention code [1] 269289 0
Diagnosis / Prognosis
Comparator / control treatment
Level 1 Polysomnography
Control group
Active

Outcomes
Primary outcome [1] 279526 0
Functional Outcomes of Sleep Questionnaire (FOSQ) to assess ability to perform activities of daily living in the context of excessive sleepiness
Timepoint [1] 279526 0
baseline and 4 months post-sleep study
Secondary outcome [1] 287838 0
Epworth Sleepiness Scale (ESS) to assess daytime sleepiness
Timepoint [1] 287838 0
baseline and 4 months
Secondary outcome [2] 287839 0
CPAP Adherence (if being prescribed to patient), measured by download of information (ie average hours of use per night) which is stored on CPAP devices
Timepoint [2] 287839 0
baseline and 4 months
Secondary outcome [3] 287840 0
Sleep Apnea Symptoms Questionnaire (SASQ) to assess severity of symptoms of OSA
Timepoint [3] 287840 0
baseline and 4 months
Secondary outcome [4] 287841 0
Short Form-12 (SF-12) to assess quality of life
Timepoint [4] 287841 0
baseline and 4 months
Secondary outcome [5] 287842 0
Sleep Physician confidence and treatment decisions, using a questionnaire which rates physicians' confidence in their diagnosis and treatment decisions
Timepoint [5] 287842 0
Pre-sleep study, Immediately post-sleep study and at 4 months
Secondary outcome [6] 287843 0
Patient satisfaction survey, using a questionnaire containing 3 questions about satisfaction with the ir management during the study which is scored on a 7 point Likert Scale
Timepoint [6] 287843 0
4 months
Secondary outcome [7] 287844 0
Health care utilisation and costs, with MBS and PBS data to be obtained from Medicare Australia, monitoring of sleep techinician time to prepare and report sleep studies, CPAP nurse appointments, approximation of CPAP equipment costs, and obtaining hospital admission data during the study by patient questionnaire at the end of the follow-up period.
Timepoint [7] 287844 0
4 months

Eligibility
Key inclusion criteria
1) Patients must be aged between 25-80 years. 2) Are referred to a sleep disorders centre for investigation of suspected OSA. 3) Report at least 2 of the following symptoms: snoring, witnessed apneas and/or excessive daytime sleepiness.
Minimum age
25 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Have had a previous sleep study
2) Referral for a non-respiratory sleep disorder
3) Have a severe psychiatric disorder or cognitive impairment that may affect the ability of the subject to comply with the study protocol
4) Suffer from neuromuscular disease, severe chronic obstructive (FEV1/FVC <70% and FEV1 <50% predicted) or restrictive (TLC <70% predicted) pulmonary disease, or require supplemental oxygen
6) Have unstable cardiovascular disease or cardiac failure (ie New York Heart Association categories III-IV)

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)
Eligible patients will be invited to participate in the study by their sleep physician during their initial consultation. Interested patients will undergo further screening by a Research Assistant, and if confirmed to fulfil all eligibility criteria, will be randomised into one of the three treatment groups. The research assistant will make contact with a representative in the statistics department at the Woolcock Medical Research Institute, who is independent of the study to inform of the randomisation allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random numbers sequence will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study is designed to test for noninferiority of functional outcomes following Level 3 and Level 4 sleep study testing, versus Level 1 (full polysomnography) for the diagnosis of OSA.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2011
Actual
2/04/2012
Date of last participant enrolment
Anticipated
Actual
29/07/2014
Date of last data collection
Anticipated
Actual
29/11/2014
Sample size
Target
400
Accrual to date
Final
406
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
Recruitment postcode(s) [1] 4411 0
5041
Recruitment postcode(s) [2] 4412 0
3168
Recruitment postcode(s) [3] 4413 0
3181
Recruitment postcode(s) [4] 4414 0
5000
Recruitment postcode(s) [5] 4415 0
2037
Recruitment postcode(s) [6] 4416 0
2050
Recruitment postcode(s) [7] 4417 0
6009

Funding & Sponsors
Funding source category [1] 269751 0
Other Collaborative groups
Name [1] 269751 0
Australasian Sleep Trials Network
Country [1] 269751 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Sleep Trials Network
Address
PO Box 36,
Tintenbar
New South Wales 2478
Country
Australia
Secondary sponsor category [1] 268790 0
Charities/Societies/Foundations
Name [1] 268790 0
Foundation Daw Park
Address [1] 268790 0
216 Daws Road
Daw Park SA 5041
Country [1] 268790 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271716 0
Southern Adelaide Clinical Research Ethics Department
Ethics committee address [1] 271716 0
Room 2A/221 Level 2
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 271716 0
Australia
Date submitted for ethics approval [1] 271716 0
23/05/2011
Approval date [1] 271716 0
14/06/2011
Ethics approval number [1] 271716 0
1/11/0258
Ethics committee name [2] 271717 0
Southern Health Human Research Ethics Committee
Ethics committee address [2] 271717 0
246 Clayton Road
Clayton
Victoria 3168
Ethics committee country [2] 271717 0
Australia
Date submitted for ethics approval [2] 271717 0
24/03/2011
Approval date [2] 271717 0
10/06/2011
Ethics approval number [2] 271717 0
HREC/11/SHA/15

Summary
Brief summary
Currently, patients who are suspected of having obstructive sleep apnea (OSA) need to be seen by a sleep specialist and undergo a full sleep study in a laboratory to confirm the diagnosis. A full sleep study involves monitoring of brain waves, eye and chin muscle movements to determine different stages of sleep, breathing patterns, oxygen levels, heart rate and leg movements. Waiting lists to see a specialist and have a laboratory sleep study can often be long, even up to 6-12 months in some centres. To address this problem, increasing numbers of simplified sleep recording devices designed to be used in the patients’ own home are being developed, and have a smaller number of channels recording only breathing patterns and/or oxygen levels overnight, without recording of brain waves to determine stages of sleep. It is currently unclear whether patients who undergo simplified sleep study recordings to test for OSA have treatment results (for example, in the degree of improvement in their symptoms) compared to patients who undergo full sleep studies. In this study, patients referred to a sleep specialist for investigation of possible OSA will be randomly assigned to one of three groups for diagnosis: (1) an overnight sleep study with full monitoring of brain waves, eye and chin muscle movements, breathing patterns, oxygen levels, heart rate and leg movements; (2) an overnight sleep study with monitoring of only breathing patterns, oxygen levels, and heart rate or (3) an overnight sleep study with monitoring of only oxygen levels. The aim of the study is see whether patients who receive treatment from a sleep specialist on the basis of a simplified sleep study recording will do as well (in terms of improvement in symptoms and ability to perform usual daily activities) as patients who have had a full sleep study after 3 months of follow-up.
Trial website
Trial related presentations / publications
Chai-Coetzer CL, Antic NA, Hamilton GS et al. Physician Decision Making and Clinical Outcomes With Laboratory Polysomnography or Limited-Channel Sleep Studies for Obstructive Sleep Apnea: A Randomized Trial. Ann Intern Med. 2017;166(5):332-340
Public notes

Contacts
Principal investigator
Name 33087 0
Dr Ching Li Chai-Coetzer
Address 33087 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road, Daw Park, SA 5041
Country 33087 0
Australia
Phone 33087 0
+61882751187
Fax 33087 0
Email 33087 0
[email protected]
Contact person for public queries
Name 16334 0
Ching Li Chai-Coetzer
Address 16334 0
Adelaide Institute for Sleep Health
Daws Road,
Daw Park, SA, 5041
Country 16334 0
Australia
Phone 16334 0
+61 8 8275 1187
Fax 16334 0
+61 8 8277 6890
Email 16334 0
[email protected]
Contact person for scientific queries
Name 7262 0
Ching Li Chai-Coetzer
Address 7262 0
Adelaide Institute for Sleep Health
Daws Road,
Daw Park, SA, 5041
Country 7262 0
Australia
Phone 7262 0
+61 8 8275 1187
Fax 7262 0
+61 8 8277 6890
Email 7262 0
[email protected]

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