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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)
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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
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Secondary ID [1]
313578
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MRFF 2035716
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Universal Trial Number (UTN)
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Trial acronym
SIMPLIFI-OSA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea
336106
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Condition category
Condition code
Respiratory
332659
332659
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0
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330172
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Diagnosis / Prognosis
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Excessive daytime sleepiness
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Assessment method [1]
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Epworth Sleepiness Scale (ESS)
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Timepoint [1]
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Baseline and 6 months post-test
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Secondary outcome [1]
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Patient preferences, satisfaction, and experience
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Assessment method [1]
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Patient preference, satisfaction and experience survey which will be designed specifically for this study
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Timepoint [1]
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Immediately post-test and 6 months post-test
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Secondary outcome [2]
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Quality of life
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Assessment method [2]
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Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)
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Timepoint [2]
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Baseline and 6 months post-test
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Secondary outcome [3]
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Sleep physician decision-making
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Assessment method [3]
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Investigations ordered. This will be assessed via physician-completed, study-specific questionnaires.
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Timepoint [3]
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Baseline, immediately post-test, and 6 months post-test
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Secondary outcome [4]
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Sleep physician decision-making
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Assessment method [4]
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Treatments recommended. This will be assessed via physician-completed, study-specific questionnaires.
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Timepoint [4]
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Baseline, immediately post-test, and 6 months post-test
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Secondary outcome [5]
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Blood pressure
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Assessment method [5]
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Resting seated blood pressure using a manual sphygmomanometer
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Timepoint [5]
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Baseline and 6 months post-test
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Secondary outcome [6]
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Diagnostic accuracy of limited-channel sleep study devices vs polysomnography
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Assessment method [6]
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apnoea-hypopnea index (AHI)
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Timepoint [6]
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Upon completion of PSG testing
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Secondary outcome [7]
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Quality of life
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Assessment method [7]
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PROMIS Sleep Disturbance Short Form (PROMIS SD SF)
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Timepoint [7]
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Baseline and 6 months post-test
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Secondary outcome [8]
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Sleep physician decision-making
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Assessment method [8]
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Primary diagnosis. These will be assessed via physician-completed, study-specific questionnaires.
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Timepoint [8]
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Baseline, immediately post-test, and 6 months post-test
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Secondary outcome [9]
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Sleep apnoea symptoms
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Assessment method [9]
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Sleep Apnea Symptoms Questionnaire (SASQ)
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Timepoint [9]
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Baseline and 6 months post-test
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Secondary outcome [10]
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Diagnostic accuracy of limited-channel sleep study devices vs polysomnography
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Assessment method [10]
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oxygen desaturation index
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Timepoint [10]
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Upon completion of PSG testing
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Secondary outcome [11]
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Quality of life
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Assessment method [11]
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PROMIS Sleep Related Impairment Short Form (PROMIS SRI SF)
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Timepoint [11]
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Baseline and 6 months post-test
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Secondary outcome [12]
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Depression
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Assessment method [12]
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Hospital Anxiety and Depression Scale
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Timepoint [12]
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Baseline and 6 months post-test
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Secondary outcome [13]
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Treatments used
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Assessment method [13]
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Treatments reported by participants and physicians using study-specific questionnaires
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Timepoint [13]
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6 months post-test
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Secondary outcome [14]
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Anxiety
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Assessment method [14]
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Hospital Anxiety and Depression Scale (HADS)
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Timepoint [14]
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Baseline and 6 months post-test
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Secondary outcome [15]
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Body mass index
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Assessment method [15]
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Calculated from weight (via electronic scales) and height (via stadiometer)
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Timepoint [15]
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Baseline and 6 months post-test
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Secondary outcome [16]
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Sleep physician confidence
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Assessment method [16]
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Diagnostic confidence. This will be assessed via physician-completed, study-specific 5-point confidence rating scale.
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Timepoint [16]
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Baseline, immediately post-test, and 6 months post-test
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Secondary outcome [17]
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Quality of life
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Assessment method [17]
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EuroQOL 5-Dimension 5-Level (EQ-5D-5L)
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Timepoint [17]
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Baseline and 6 months post-test
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Secondary outcome [18]
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Weight
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Assessment method [18]
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Electronic scales
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Timepoint [18]
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Baseline and 6 months post-test
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Secondary outcome [19]
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Health economics analyses
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Assessment method [19]
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Medical Benefits Schedule (MBS) & Pharmaceutical Benefits Schedule (PBS) data; Australian Refined Diagnosis Related Groups (AR-DRG) hospital admissions data; Resource use questionnaire which will be designed specifically for this study.
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Timepoint [19]
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6 months post-test
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Secondary outcome [20]
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CPAP adherence
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Assessment method [20]
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CPAP device analytics from device download
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Timepoint [20]
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6 months post-test
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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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
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/03/2025
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Actual
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Date of last participant enrolment
Anticipated
30/06/2027
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Actual
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Date of last data collection
Anticipated
30/12/2027
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Actual
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Sample size
Target
384
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
27425
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Adelaide Institute for Sleep Health, Flinders University - Bedford Park
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Recruitment hospital [2]
27426
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [3]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [4]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [5]
27429
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [6]
27427
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Eastern Health - Box Hill
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Recruitment postcode(s) [1]
43541
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2065 - St Leonards
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Recruitment postcode(s) [2]
43538
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3168 - Clayton
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Recruitment postcode(s) [3]
43540
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3084 - Heidelberg
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Recruitment postcode(s) [4]
43539
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3128 - Box Hill
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Recruitment postcode(s) [5]
43537
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Health and Aged Care - Medical Research Future Fund
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Eastern Health
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Address [1]
320394
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Country [1]
320394
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Australia
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Secondary sponsor category [2]
320396
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Government body
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Name [2]
320396
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Royal North Shore Hospital
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Address [2]
320396
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Country [2]
320396
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Australia
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Secondary sponsor category [3]
320395
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Government body
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Name [3]
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Monash Health
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Address [3]
320395
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Country [3]
320395
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Australia
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Secondary sponsor category [4]
320393
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Government body
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Name [4]
320393
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Austin Health
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Address [4]
320393
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Country [4]
320393
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Australia
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Secondary sponsor category [5]
320391
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Government body
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Name [5]
320391
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Southern Adelaide Local Health Network
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Address [5]
320391
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Country [5]
320391
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Australia
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Other collaborator category [1]
283329
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Charities/Societies/Foundations
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Name [1]
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Sleep Health Foundation
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Address [1]
283329
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Country [1]
283329
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Australia
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Other collaborator category [2]
283328
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Charities/Societies/Foundations
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Name [2]
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Australasian Sleep Association
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Address [2]
283328
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Country [2]
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Australia
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Other collaborator category [3]
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Commercial sector/Industry
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Name [3]
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Nox Medical
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Address [3]
283331
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Country [3]
283331
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Iceland
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Other collaborator category [4]
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Commercial sector/Industry
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Name [4]
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Compumedics
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Address [4]
283330
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Country [4]
283330
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Australia
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Other collaborator category [5]
283332
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Commercial sector/Industry
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Name [5]
283332
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Zoll Itamar
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Address [5]
283332
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Country [5]
283332
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Israel
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
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https://www.sahealth.sa.gov.au/wps/wcm/connect/Public%2BContent/SA%2BHealth%2BInternet/About%2Bus/Our%2BLocal%2BHealth%2BNetworks/Southern%2BAdelaide%2BLocal%2BHealth%2BNetwork/Research/For%2BResearchers/Southern%2BAdelaide%2BClinical%2BHuman%2BResearch%2BEthics%2BCommittee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316698
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25/10/2024
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Approval date [1]
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16/12/2024
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Ethics approval number [1]
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2024/HRE00236
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Summary
Brief summary
This study will compare the effects of simplified sleep study testing (with fewer monitoring channels than usual) versus full sleep studies for the diagnosis of obstructive sleep apnea (OSA), by investigating the accuracy of 3 different simplified sleep study devices, their impacts on physician decision-making and important patient outcomes (including symptoms of daytime sleepiness) and whether the use of simplified testing devices in the management of OSA is associated with significant cost savings. The study hypothesis is that limited-channel sleep study testing is accurate, effective and cost-effective compared to full sleep study testing in the diagnosis and management of patients with suspected OSA.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Ching Li Chai-Coetzer
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Address
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Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, South Australia 5042
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Country
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Australia
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Phone
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+61 8 7221 8313
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ching Li Chai-Coetzer
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Address
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Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, South Australia 5042
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Country
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Australia
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Phone
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+61 8 7221 8313
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Fax
138711
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ching Li Chai-Coetzer
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Address
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Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, South Australia 5042
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Country
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Australia
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Phone
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+61 8 7221 8313
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Fax
138712
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Email
138712
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[email protected]
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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.
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