Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000279426
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
11/04/2025
Date last updated
11/04/2025
Date data sharing statement initially provided
11/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of multi-night screening and diagnosis of
obstructive sleep apnoea -assessing diagnostic test accessibility, accuracy and impact on participant costs.
Scientific title
A randomised controlled trial of multi-night screening and diagnosis of
obstructive sleep apnoea in adults - assessing diagnostic test accessibility, accuracy and impact on participant costs.
Secondary ID [1] 313657 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep apnoea 336533 0
Condition category
Condition code
Respiratory 333046 333046 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to one of 2 different diagnostic pathways. Pathways 1 and 2 will receive identical multi-night sleep evaluations as well as conventional 1-night polysomnography (PSG) test. The only difference between pathway 1 and 2 is the order in which sleep physicians will receive the clinical data to make diagnostic decisions from, Physicians will provide their initial diagnosis (primary outcome) based on either multi-night screening data or conventional 1-night PSG. Pathway 1 will receive the multi-night data first for the physician to determine the presence of sleep apnoea and then will receive the single night PSG data; Pathway 2 will receive the single night PSG data first, followed by the multi-night data and physicians will be asked to make decisions about the presence of sleep apnoea and diagnostic accuracy. Multi-night measurements will include an under-mattress sleep sensor device, such as the Withings Sleep Analyzer (Withings) to be used for up to 14 nights, a forehead-worn electrode sensor device such as Somfit (Compumedics) to be used for up to 7 nights, and a simple ring-like oximeter device worn on a finger, such as the Wellvue pulse oximeter to be used for up to 7 nights. The forehead-worn electrode sensor device and the simple ring-like oximeter will be used simultaneously ie both worn together and the under-mattresss sensor will also be used on the same nights with these 2 devices. Device analytics will allow measurement of sleep duration, severity of OSA and whether the device was applied successfully. In addition to the multi-night assessments, participants will undergo a full PSG sleep study at a separate timepoint . These two pathways will differ only in the order with which physicians receive multi-night data, either before or after single night PSG data and this will occur prior to review with the participant and commencement of any treatment. Physicians will undergo an education session prior to the first participant being recruited on how to interpret the data from the devices. Participants (patients) will receive training in how to use the devices (as per manufacturers instructions) by clinical staff at the sleep laboratory or by research assistants/coordinators at each site with telephone support for participants. The overall duration of sleep assessment using the multi-night devices will be 14 days after randomisation. Participants(patients) will undergo follow-up to capture and compare short- (3 months) and longer-term (12 and 24 months) clinical outcomes for OSA in terms of symptoms, quality of life, therapy used for OSA which will be measured by questionnaires. Medicare and Pharmaceutical benefits data for each participant will also be obtained.
Intervention code [1] 330522 0
Diagnosis / Prognosis
Comparator / control treatment
Pathway 3 will receive standard 1-night PSG diagnosis alone and this is the usual care pathway. Standard single night polysomnography either at home (Level 2) or in a sleep laboratory (Level 1) as is the current clinical standard for the diagnosis of obstructive sleep apnoea. The determination of whether the PSG will be done at home or in the sleep laboratory will occur based on preference of the patient and/or the sleep physician. PSG involves a sleep scientist placing several electrodes and sensors on the participant in a standardised way to measure electro-encephalography, electromyography, oximetry, nasal and oral airflow, chest and abdominal movement, electrocardiogram, leg movement sensors, body position and sound during sleep. This procedure for set up of the PSG takes about 1 hour. For home PSG (Level 2) the participant will be given education on what to do when they get home. For a laboratory based PSG (Level 1) sleep scientists are present in the control room of the laboratory and can enter the participant room to re-attach sensors if they become detached during the night.
Control group
Active

Outcomes
Primary outcome [1] 340678 0
Diagnostic accuracy of a multi-night under mattress sensor device (Withings) versus single night polysomnography
Timepoint [1] 340678 0
After initial rounds of testing
Secondary outcome [1] 445815 0
Physician determined OSA severity of multi-night OSA devices (under mattress sensor device (Withings) and Forehead sensor (Somfit) and ring oximetry (Wellue) versus single night polysomnography. Composite secondary outcome.
Timepoint [1] 445815 0
After initial rounds of testing
Secondary outcome [2] 444771 0
Alertness
Timepoint [2] 444771 0
Baseline, 3 , 12, and 24 months after sleep study
Secondary outcome [3] 444762 0
Quality of life
Timepoint [3] 444762 0
Baseline, 3, 12, 24 months after sleep study.
Secondary outcome [4] 445827 0
Apnoea hypopnoea index or equivalent measured by the ring oximeter
Timepoint [4] 445827 0
After initial rounds of testing
Secondary outcome [5] 444764 0
Quality of Life
Timepoint [5] 444764 0
Baseline, 3 , 12, and 24 months after sleep study
Secondary outcome [6] 444763 0
Depression
Timepoint [6] 444763 0
Baseline, 3, 12 and 24 months.
Secondary outcome [7] 444767 0
Quality of life
Timepoint [7] 444767 0
baseline, 3,12 and 24 months after sleep study
Secondary outcome [8] 445817 0
Anxiety
Timepoint [8] 445817 0
Baseline, 3, 12, 24 months after sleep study.
Secondary outcome [9] 445812 0
Physician-determined OSA severity of multi-night under mattress sensor device (Withings) versus single night polysomnography
Timepoint [9] 445812 0
After initial rounds of testing
Secondary outcome [10] 444768 0
Snoring
Timepoint [10] 444768 0
Baseline, 3, 12 and 24 months after sleep study
Secondary outcome [11] 444772 0
Physical activity
Timepoint [11] 444772 0
Baseline, 3, 12, 24 months after sleep study.
Secondary outcome [12] 444760 0
Excessive daytime sleepiness
Timepoint [12] 444760 0
Baseline, 3, 12, 24 months after sleep study.
Secondary outcome [13] 444761 0
Insomnia
Timepoint [13] 444761 0
Baseline, 3, 12, 24 months after sleep study.
Secondary outcome [14] 444766 0
Sleep Quality
Timepoint [14] 444766 0
Baseline, 3 , 12, and 24 months after sleep study
Secondary outcome [15] 444770 0
Sleepiness
Timepoint [15] 444770 0
Baseline, 3 , 12, and 24 months after sleep study
Secondary outcome [16] 445816 0
Consensus sleep physician panel diagnostic accuracy of OSA
Timepoint [16] 445816 0
After initial rounds of testing
Secondary outcome [17] 444769 0
Health economics analysis
Timepoint [17] 444769 0
Baseline, 3 , 12, and 24 months after sleep study
Secondary outcome [18] 445814 0
Diagnostic confidence of multi-night OSA devices (under mattress sensor device (Withings) and Forehead sensor (Somfit) and ring oximetry (Wellue) versus single night polysomnography. Composite secondary outcome.
Timepoint [18] 445814 0
After initial rounds of testing
Secondary outcome [19] 444773 0
Technology interaction
Timepoint [19] 444773 0
After initial rounds of testing
Secondary outcome [20] 445818 0
Stress
Timepoint [20] 445818 0
Baseline, 3, 12, 24 months after sleep study.
Secondary outcome [21] 444765 0
Quality of Life
Timepoint [21] 444765 0
Baseline, 3 , 12, and 24 months after sleep study
Secondary outcome [22] 445822 0
Apnoea hypopnoea index measured from the multi-night under mattress sensor (Withings)
Timepoint [22] 445822 0
After initial round of testing
Secondary outcome [23] 445828 0
Apnoea hypopnoea index measured by single-night polysomnography
Timepoint [23] 445828 0
After initial round of testing
Secondary outcome [24] 445813 0
Diagnostic accuracy of multi-night OSA devices (under mattress sensor device (Withings) and Forehead sensor (Somfit) and ring oximetry (Wellue) versus single night polysomnography. Composite secondary outcome.
Timepoint [24] 445813 0
After initial rounds of testing
Secondary outcome [25] 445807 0
Diagnostic confidence of a multi-night under mattress sensor device (Withings) versus single night polysomnography
Timepoint [25] 445807 0
After initial rounds of testing
Secondary outcome [26] 445819 0
Motor vehicle accidents
Timepoint [26] 445819 0
Baseline, 3, 12, 24 months after sleep study.
Secondary outcome [27] 445826 0
Apnoea hypopnoea index as measured by the multi-night forehead sensor (Somfit)
Timepoint [27] 445826 0
After initial rounds of testing
Secondary outcome [28] 445820 0
Workplace accidents
Timepoint [28] 445820 0
Baseline, 3, 12, 24 months after sleep study.
Secondary outcome [29] 445821 0
Technology satisfaction
Timepoint [29] 445821 0
After initial rounds of testing

Eligibility
Key inclusion criteria
1. Referral to a sleep specialist for suspected obstructive sleep apnoea
2. Aged 18 years or over
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 of OSA in the past 2 years
2. Referral for a non-respiratory sleep disorder.
3. Severe psychiatric disorder or cognitive impairment which impacts the subject's ability to provide informed consent or comply with the study protocol.
4. Neuromuscular disease, severe chronic obstructive pulmonary disease, respiratory failure, unstable cardiac disease or cardiac failure (i.e. hospitalisation for a 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)
Dynamic (adaptive) random allocation methods such as Minimisation using age, sex and body mass index
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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
29/05/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2029
Actual
Date of last data collection
Anticipated
3/05/2030
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 27611 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 27612 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 27610 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 27613 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 43784 0
3084 - Heidelberg
Recruitment postcode(s) [2] 43785 0
5000 - Adelaide
Recruitment postcode(s) [3] 43783 0
5042 - Bedford Park
Recruitment postcode(s) [4] 43786 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 318123 0
Government body
Name [1] 318123 0
Department of Health and Aged Care-Medical Research Future Fund
Country [1] 318123 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320813 0
Charities/Societies/Foundations
Name [1] 320813 0
Sleep Disorders Australia
Address [1] 320813 0
Country [1] 320813 0
Australia
Secondary sponsor category [2] 320810 0
Other Collaborative groups
Name [2] 320810 0
Institute for Breathing and sleep
Address [2] 320810 0
Country [2] 320810 0
Australia
Secondary sponsor category [3] 320811 0
Government body
Name [3] 320811 0
Austin Health
Address [3] 320811 0
Country [3] 320811 0
Australia
Secondary sponsor category [4] 320816 0
Charities/Societies/Foundations
Name [4] 320816 0
Australasian Sleep Association
Address [4] 320816 0
Country [4] 320816 0
Australia
Secondary sponsor category [5] 320815 0
Charities/Societies/Foundations
Name [5] 320815 0
Sleep Health Foundation
Address [5] 320815 0
Country [5] 320815 0
Australia
Secondary sponsor category [6] 320812 0
Commercial sector/Industry
Name [6] 320812 0
Compumedics
Address [6] 320812 0
Country [6] 320812 0
Australia
Secondary sponsor category [7] 320817 0
Charities/Societies/Foundations
Name [7] 320817 0
Q sleep
Address [7] 320817 0
Country [7] 320817 0
Australia
Secondary sponsor category [8] 320506 0
Government body
Name [8] 320506 0
Southern Adelaide Local Health Network
Address [8] 320506 0
Country [8] 320506 0
Australia
Secondary sponsor category [9] 320814 0
Commercial sector/Industry
Name [9] 320814 0
Withings
Address [9] 320814 0
Country [9] 320814 0
France
Secondary sponsor category [10] 320808 0
Government body
Name [10] 320808 0
Central Adelaide Local Health Network
Address [10] 320808 0
Country [10] 320808 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316770 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 316770 0
Ethics committee country [1] 316770 0
Australia
Date submitted for ethics approval [1] 316770 0
28/11/2024
Approval date [1] 316770 0
28/02/2025
Ethics approval number [1] 316770 0
2024/HRE00318

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

Contacts
Principal investigator
Name 138958 0
Prof Sutapa Mukherjee
Address 138958 0
Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, SA 5042
Country 138958 0
Australia
Phone 138958 0
+61884324242
Fax 138958 0
Email 138958 0
[email protected]
Contact person for public queries
Name 138959 0
Sutapa Mukherjee
Address 138959 0
Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, SA 5042
Country 138959 0
Australia
Phone 138959 0
+61884324242
Fax 138959 0
Email 138959 0
[email protected]
Contact person for scientific queries
Name 138960 0
Sutapa Mukherjee
Address 138960 0
Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park, SA 5042
Country 138960 0
Australia
Phone 138960 0
+61884324242
Fax 138960 0
Email 138960 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.