Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000847516
Ethics application status
Approved
Date submitted
10/05/2024
Date registered
9/07/2024
Date last updated
9/07/2024
Date data sharing statement initially provided
9/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A study on the Bonsai Sensor on participants with or without Obstructive Sleep Apnoea (OSA) to assess signal parameters
Scientific title
A prospective study on participants with or without Obstructive Sleep Apnoea (OSA) to assess signal parameters of the Bonsai Sensor across different builds or design iterations of the device.
Secondary ID [1] 310397 0
SLP-23-08-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
N/A 334123 0
Condition category
Condition code
Respiratory 327927 327927 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Bonsai system consists of a small sensor device which is placed on the fingertip, the Bonsai Sensor, and a cloud-based analytics platform, the Bonsai software. The Bonsai system is able to derive diagnostic parameters recommended by The AASM Manual for the Scoring of Sleep and Associated Events for home sleep apnea testing utilizing peripheral arterial tonometry and was validated against in-laboratory polysomnography (PSG).

The purpose of this protocol is to assess the Bonsai Sensor signal parameters and may compare different builds or design iterations. For the purpose of this study the Bonsai sensors are not used to screen nor diagnose Obstructive Sleep Apnoea (OSA). One build of the sensor may be sampled and evaluated for each sub-study. Alternatively, a sub-study may compare sensors sampled from different build or design iterations. If different builds or iterations are tested in the same sub-study the participants will wear the different types on the same hand (e.g. one on the middle finger and another type on the index finger). Alternatively, the same test protocol may be repeated for different builds. Each sub-study protocol will determine the need for assessing specific build(s)/design iteration (e.g. extent of design modification). Examples of different builds/design iterations to be assessed may include newly commissioned manufacturing lines, new vendors for parts supplied or minor change in manufacturing processes or design of specific parts. The engineering team will assess the extent of the impact and need for testing on participants in addition to engineering bench testing. The way the participants are required to apply or use the device is not expected to be different in sub-protocols.

Each participant will apply 2 sensors to the same hand, one on the index finger and one on the middle finger of the left or right hand, and connect each sensor to the Bonsai smartphone app to perform overnight recordings. Each participant will test a total of 6 sensors over 3 nights. Recorded data will be analysed by the currently released algorithm. In the case of unsuccessful recordings, participants will be asked to try to repeat the recordings for additional 2 nights maximum. Instructions will be provided to the participants via the smartphone app and the study specific instructions sheet.

Sub-studies under this protocol are estimated to be run for 4-8 weeks from recruitment to all participants completing the sub-study. This study is going to be conducted remotely or face to face by Medical Affairs department of ResMed, with recruitment activities run across Australia. Participants with or without diagnosis of Obstructive Sleep Apnoea will be screened and enrolled.

Participants may take part in multiple sub-studies however will not be asked to use the sensor for more than 5 nights consecutively (i.e.., the involvement in 2 sub-studies will not be one after the other without a break in between).
Intervention code [1] 326799 0
Early detection / Screening
Comparator / control treatment
A sub-study may compare sensors sampled from different builds or design iterations.
Each sub-study protocol will specify the details of the comparison (e.g. comparison between 2 different design iterations against specifications: or comparison of one build/design iteration against specific criteria).
Control group
Active

Outcomes
Primary outcome [1] 335779 0
Percentages of successful recordings that do not need to be repeated.

The Bonsai app has internal algorithm to determine if recordings of a night is successful based on e.g. duration of recording and characteristics of raw signals and inform the participants about the need for re-recording.
Timepoint [1] 335779 0
After 3 nights of successful recordings, or to a max of 5 nights if any of the recordings are unsuccessful and need to be repeated.
Primary outcome [2] 338397 0
Review of the signals recorded when relevant (e.g. Incomplete recordings)

The Bonsai app has internal algorithm to determine if recordings of a night is successful based on e.g. duration of recording and characteristics of raw signals and inform the participants about the need for re-recording. If recording of a specific night were deemed unsuccessful by the app, it will be classified as incomplete. Recordings will be collected and hosted in the Bonsai cloud platform and will only have de-identified participant information.
Timepoint [2] 338397 0
After 3 nights of successful recordings, or to a max of 5 nights if any of the recordings are unsuccessful and need to be repeated.
Secondary outcome [1] 425582 0
N/A
Timepoint [1] 425582 0
N/A

Eligibility
Key inclusion criteria
Participants willing to give written informed consent
Participants who >/= 18 years of age
Participants who are willing test the sensors for 3 nights, and up to 5 nights
Participants owning an iPhone (generation 7 and later) on which the participant can download the app used for the study
(Obstructive Sleep Apnoea (OSA). Participants in this study may or may not have OSA)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who are or may be pregnant
Participants with clinically relevant peripheral vascular disease, such as secondary Raynaud’s disease.
Participants believed to be unsuitable for inclusion by the researcher

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There will be no statistical analysis or hypothesis testing, rather recordings will be assessed and tested sensors classified as categories of failure or pass. Descriptive statistics (e.g., percentage) or graphs could be used in reporting/presentations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2029
Actual
Date of last data collection
Anticipated
25/05/2029
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314603 0
Commercial sector/Industry
Name [1] 314603 0
ResMed Pty Ltd
Country [1] 314603 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Pty Ltd
Address
ResMed 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, Australia
Country
Australia
Secondary sponsor category [1] 316566 0
None
Name [1] 316566 0
Address [1] 316566 0
Country [1] 316566 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313632 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 313632 0
Ethics committee country [1] 313632 0
Australia
Date submitted for ethics approval [1] 313632 0
18/03/2024
Approval date [1] 313632 0
28/05/2024
Ethics approval number [1] 313632 0

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

Contacts
Principal investigator
Name 128806 0
Dr Jeffrey Armitstead
Address 128806 0
ResMed 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, Australia
Country 128806 0
Australia
Phone 128806 0
+61 288842203
Fax 128806 0
Email 128806 0
[email protected]
Contact person for public queries
Name 128807 0
Xueling Zhu
Address 128807 0
ResMed 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, Australia
Country 128807 0
Australia
Phone 128807 0
+61 288842367
Fax 128807 0
Email 128807 0
[email protected]
Contact person for scientific queries
Name 128808 0
Xueling Zhu
Address 128808 0
ResMed 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, Australia
Country 128808 0
Australia
Phone 128808 0
+61 288842367
Fax 128808 0
Email 128808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study may reveal participants having undiagnosed OSA or suboptimal treatment (if the participant had prior diagnosis of Obstructive Sleep Apnoea and were on Continuous Positive Airway Pressure (CPAP) when joined the study). In both situations the study researchers will provide further instructions for the participants to seek advice from their healthcare providers (HCP) to be assessed. They will be given reports from the Bonsai system to bring to their HCPs.
Other than situations described above data collected for the study will not be shared with the participants or externally. The study will follow the usual privacy and confidentiality in the protocol and relevant guidelines.


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.