Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000032459
Ethics application status
Approved
Date submitted
16/12/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Investigate the Management of Patients using LImited-channel testing versus Full polysomnography for Identification of Obstructive Sleep Apnoea (SIMPLIFI-OSA)
Scientific title
A randomised controlled trial to evaluate the diagnostic accuracy, clinical effectiveness and cost-effectiveness of limited-channel sleep studies versus full polysomnography for diagnosis and management of obstructive sleep apnea
Secondary ID [1] 313578 0
MRFF 2035716
Universal Trial Number (UTN)
Trial acronym
SIMPLIFI-OSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea 336106 0
Condition category
Condition code
Respiratory 332659 332659 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to one of four study arms (1:1:1:1) for diagnostic sleep study evaluation. The 4 arms will consist of a control arm (home or laboratory PSG) and 3 different type 3 or 4 (limited-channel) sleep study devices.
ARM 1: Nox T3 (Nox Medical), a traditional type 3 device which measures thoracic and abdominal respiratory inductance plethysmography (RIP), nasal pressure, snore signal, oximetry and pulse.
ARM 2: Watch-PAT 1M (ZOLL Itamar), a peripheral arterial tonometry (PAT) device which records a PAT signal, heart rate, oximetry, body position, snoring and chest motion via 3 points of contact (i.e., chest sensor, wristband device and finger probe) and utilises a smartphone app to transmit sleep study data to the cloud.
ARM 3: Somfit (Compumedics Ltd), a novel device which consists of a sensor worn on the forehead that measures EEG, EOG and EMG, pulse oximetry and PAT signal, and transmits data to a smartphone app via Bluetooth.

Participants in type 3/4 intervention arms will use their allocated limited-channel device for 3 consecutive nights to assess the impacts of night-to-night variability and potential benefit of undertaking multi-night recordings compared to single-night testing. On night 1, all patients allocated to type 3/4 study arms will undergo simultaneous testing with full PSG (i.e., type 1 or 2) and their allocated simplified study device. On nights 2 and 3, patients in type 3/4 arms will continue to use the same limited-channel study device on its own at home.

At the post-test follow-up visit, sleep physicians will be given a sleep study report and access to raw data corresponding to their patient’s randomised study arm. For patients in type 3/4 intervention arms, physicians will be given a report generated using auto-scored data from their relevant device recorded on night 1 (single night), access to routinely-available raw data, and will be blinded to PSG data. Sleep physicians will use the sleep study information as a basis for further diagnostic and management decisions, and OSA treatments will be recommended at their discretion, as per usual clinical practice.
Intervention code [1] 330172 0
Diagnosis / Prognosis
Comparator / control treatment
Patients in the control arm will undergo type 1 or 2 full PSG testing for a single night as per current standard clinical practice. We anticipate that most patients will undergo type 2 (home) PSG, however, we will allow for type 1 (in-laboratory) PSG as required to enable the inclusion of patients requiring laboratory-based testing, for example, from rural-remote regions who would usually travel long distances to and stay overnight in a sleep laboratory for diagnostic testing. Type 1 and 2 PSG will involve monitoring of electroencephalography, electrooculography, chin and leg electromyography, airflow, thoracoabdominal
bands, snoring sensor, body position, electrocardiography, and oxygen saturation.
Control group
Active

Outcomes
Primary outcome [1] 340163 0
Excessive daytime sleepiness
Timepoint [1] 340163 0
Baseline and 6 months post-test
Secondary outcome [1] 443067 0
Patient preferences, satisfaction, and experience
Timepoint [1] 443067 0
Immediately post-test and 6 months post-test
Secondary outcome [2] 443061 0
Quality of life
Timepoint [2] 443061 0
Baseline and 6 months post-test
Secondary outcome [3] 443561 0
Sleep physician decision-making
Timepoint [3] 443561 0
Baseline, immediately post-test, and 6 months post-test
Secondary outcome [4] 443562 0
Sleep physician decision-making
Timepoint [4] 443562 0
Baseline, immediately post-test, and 6 months post-test
Secondary outcome [5] 443064 0
Blood pressure
Timepoint [5] 443064 0
Baseline and 6 months post-test
Secondary outcome [6] 443058 0
Diagnostic accuracy of limited-channel sleep study devices vs polysomnography
Timepoint [6] 443058 0
Upon completion of PSG testing
Secondary outcome [7] 443573 0
Quality of life
Timepoint [7] 443573 0
Baseline and 6 months post-test
Secondary outcome [8] 443059 0
Sleep physician decision-making
Timepoint [8] 443059 0
Baseline, immediately post-test, and 6 months post-test
Secondary outcome [9] 443060 0
Sleep apnoea symptoms
Timepoint [9] 443060 0
Baseline and 6 months post-test
Secondary outcome [10] 443564 0
Diagnostic accuracy of limited-channel sleep study devices vs polysomnography
Timepoint [10] 443564 0
Upon completion of PSG testing
Secondary outcome [11] 443574 0
Quality of life
Timepoint [11] 443574 0
Baseline and 6 months post-test
Secondary outcome [12] 443576 0
Depression
Timepoint [12] 443576 0
Baseline and 6 months post-test
Secondary outcome [13] 443066 0
Treatments used
Timepoint [13] 443066 0
6 months post-test
Secondary outcome [14] 443062 0
Anxiety
Timepoint [14] 443062 0
Baseline and 6 months post-test
Secondary outcome [15] 443577 0
Body mass index
Timepoint [15] 443577 0
Baseline and 6 months post-test
Secondary outcome [16] 443563 0
Sleep physician confidence
Timepoint [16] 443563 0
Baseline, immediately post-test, and 6 months post-test
Secondary outcome [17] 443575 0
Quality of life
Timepoint [17] 443575 0
Baseline and 6 months post-test
Secondary outcome [18] 443063 0
Weight
Timepoint [18] 443063 0
Baseline and 6 months post-test
Secondary outcome [19] 443068 0
Health economics analyses
Timepoint [19] 443068 0
6 months post-test
Secondary outcome [20] 443578 0
CPAP adherence
Timepoint [20] 443578 0
6 months post-test

Eligibility
Key inclusion criteria
1) Referral to sleep specialist for assessment of suspected OSA
2) Aged 18 years or over
3) Fulfil criteria for home sleep study testing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Previous sleep study and/or diagnosis of and/or treatment for OSA in the past 5 years
2) Referral for non-respiratory sleep disorder
3) Severe psychiatric disorder or cognitive impairment that will affect ability of the subject to provide informed consent or comply with the study protocol
4) Neuromuscular disease, severe chronic obstructive (FEV1/FVC <70% and FEV1 <50% predicted) or restrictive (TLC <50% predicted) pulmonary disease, respiratory failure from any cause, and/or require supplemental oxygen
5) Unstable cardiovascular (CV) disease or cardiac failure (i.e., hospitalisation for CV event in previous 3 months or New York Heart Association categories III-IV)

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation 1:1:1:1 with stratification according to OSA symptom severity as determined by SASQ score
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
384
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 27425 0
Adelaide Institute for Sleep Health, Flinders University - Bedford Park
Recruitment hospital [2] 27426 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 27428 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 27424 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 27429 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 27427 0
Eastern Health - Box Hill
Recruitment postcode(s) [1] 43541 0
2065 - St Leonards
Recruitment postcode(s) [2] 43538 0
3168 - Clayton
Recruitment postcode(s) [3] 43540 0
3084 - Heidelberg
Recruitment postcode(s) [4] 43539 0
3128 - Box Hill
Recruitment postcode(s) [5] 43537 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 318044 0
Government body
Name [1] 318044 0
Department of Health and Aged Care - Medical Research Future Fund
Country [1] 318044 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320394 0
Government body
Name [1] 320394 0
Eastern Health
Address [1] 320394 0
Country [1] 320394 0
Australia
Secondary sponsor category [2] 320396 0
Government body
Name [2] 320396 0
Royal North Shore Hospital
Address [2] 320396 0
Country [2] 320396 0
Australia
Secondary sponsor category [3] 320395 0
Government body
Name [3] 320395 0
Monash Health
Address [3] 320395 0
Country [3] 320395 0
Australia
Secondary sponsor category [4] 320393 0
Government body
Name [4] 320393 0
Austin Health
Address [4] 320393 0
Country [4] 320393 0
Australia
Secondary sponsor category [5] 320391 0
Government body
Name [5] 320391 0
Southern Adelaide Local Health Network
Address [5] 320391 0
Country [5] 320391 0
Australia
Other collaborator category [1] 283329 0
Charities/Societies/Foundations
Name [1] 283329 0
Sleep Health Foundation
Address [1] 283329 0
Country [1] 283329 0
Australia
Other collaborator category [2] 283328 0
Charities/Societies/Foundations
Name [2] 283328 0
Australasian Sleep Association
Address [2] 283328 0
Country [2] 283328 0
Australia
Other collaborator category [3] 283331 0
Commercial sector/Industry
Name [3] 283331 0
Nox Medical
Address [3] 283331 0
Country [3] 283331 0
Iceland
Other collaborator category [4] 283330 0
Commercial sector/Industry
Name [4] 283330 0
Compumedics
Address [4] 283330 0
Country [4] 283330 0
Australia
Other collaborator category [5] 283332 0
Commercial sector/Industry
Name [5] 283332 0
Zoll Itamar
Address [5] 283332 0
Country [5] 283332 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316698 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 316698 0
Ethics committee country [1] 316698 0
Australia
Date submitted for ethics approval [1] 316698 0
25/10/2024
Approval date [1] 316698 0
16/12/2024
Ethics approval number [1] 316698 0
2024/HRE00236

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138710 0
A/Prof Ching Li Chai-Coetzer
Address 138710 0
Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, South Australia 5042
Country 138710 0
Australia
Phone 138710 0
+61 8 7221 8313
Fax 138710 0
Email 138710 0
[email protected]
Contact person for public queries
Name 138711 0
Ching Li Chai-Coetzer
Address 138711 0
Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, South Australia 5042
Country 138711 0
Australia
Phone 138711 0
+61 8 7221 8313
Fax 138711 0
Email 138711 0
[email protected]
Contact person for scientific queries
Name 138712 0
Ching Li Chai-Coetzer
Address 138712 0
Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, South Australia 5042
Country 138712 0
Australia
Phone 138712 0
+61 8 7221 8313
Fax 138712 0
Email 138712 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.