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Trial registered on ANZCTR


Registration number
ACTRN12621000444886
Ethics application status
Approved
Date submitted
17/02/2021
Date registered
16/04/2021
Date last updated
16/04/2021
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A validation study of single-use and multi-use NightOwl home sleep tests compared to laboratory sleep study in the detection of obstructive sleep apnoea
Scientific title
A validation study of the limited channel single and multi-use NightOwl sleep testing systems compared to laboratory polysomnography in the diagnosis of obstructive sleep apnoea
Secondary ID [1] 303473 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea 320786 0
Condition category
Condition code
Respiratory 318607 318607 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective cohort study of consecutive eligible patients undergoing clinically indicated in-laboratory polysomnography (PSG). Observation is using a NightOwl device to record accelerometer and photoplethysmography data to compare with in-laboratory PSG on the same participant. These recordings will occur concurrently.
Each participant will be connected to the standard in-laboratory sleep test equipment and then will have a NightOwl device applied to two fingers on their non-dominant hand - one reusable NightOwl and one disposable NightOwl.
Testing will only be completed on the night of their scheduled in-laboratory sleep study and study participation is only for this time. There is no ongoing follow-up.
The study session is supervised by the sleep scientist conducting the sleep study.
No training for study participants is required.
Intervention code [1] 319762 0
Diagnosis / Prognosis
Comparator / control treatment
Comparison with laboratory diagnostic PSG is chosen as this is the gold standard for diagnosis of obstructive sleep apnoea.
Control group
Active

Outcomes
Primary outcome [1] 326566 0
Level of agreement between apnoea-hypopnoea index obtained from the single-use NightOwl sleep testing system and the gold standard laboratory polysomnography
Timepoint [1] 326566 0
At the time of the sleep study
Primary outcome [2] 326980 0
Level of agreement between apnoea-hypopnoea index obtained from the multi-use NightOwl sleep testing system and the gold standard laboratory polysomnography
Timepoint [2] 326980 0
At the time of the sleep study
Secondary outcome [1] 391910 0
Level of agreement between the oxygen desaturation index (ODI) obtained from the single-use NightOwl sleep test system and the gold standard laboratory polysomnography
Timepoint [1] 391910 0
At the time of the sleep study
Secondary outcome [2] 391911 0
Level of agreement between total sleep time obtained from the single-use NightOwl sleep test system and the gold standard laboratory polysomnography
Timepoint [2] 391911 0
At the time of the sleep study
Secondary outcome [3] 391912 0
Level of agreement between the proportion of mild severity obstructive sleep apnoea cases obtained form the single-use NightOwl sleep test system and the gold standard laboratory polysomnography.
Timepoint [3] 391912 0
At the time of the sleep study
Secondary outcome [4] 393332 0
Level of agreement between the oxygen desaturation index (ODI) obtained from the multi-use NightOwl sleep test system and the gold standard laboratory polysomnography
Timepoint [4] 393332 0
At the time of the sleep study
Secondary outcome [5] 393333 0
Level of agreement between total sleep time obtained from the multi-use NightOwl sleep test system and the gold standard laboratory polysomnography
Timepoint [5] 393333 0
At the time of the sleep study
Secondary outcome [6] 393334 0
Level of agreement between the proportion of mild severity obstructive sleep apnoea cases obtained form the multi-use NightOwl sleep test system and the gold standard laboratory polysomnography.
Timepoint [6] 393334 0
At the time of the sleep study
Secondary outcome [7] 393335 0
Level of agreement between the proportion of moderate severity obstructive sleep apnoea cases obtained form the single-use NightOwl sleep test system and the gold standard laboratory polysomnography.
Timepoint [7] 393335 0
At the time of the sleep study
Secondary outcome [8] 393336 0
Level of agreement between the proportion of moderate severity obstructive sleep apnoea cases obtained form the multi-use NightOwl sleep test system and the gold standard laboratory polysomnography.
Timepoint [8] 393336 0
At the time of the sleep study
Secondary outcome [9] 393337 0
Level of agreement between the proportion of severe severity obstructive sleep apnoea cases obtained form the single-use NightOwl sleep test system and the gold standard laboratory polysomnography.
Timepoint [9] 393337 0
At the time of the sleep study
Secondary outcome [10] 393338 0
Level of agreement between the proportion of severe severity obstructive sleep apnoea cases obtained form the multi-use NightOwl sleep test system and the gold standard laboratory polysomnography.
Timepoint [10] 393338 0
At the time of the sleep study

Eligibility
Key inclusion criteria
Participants aged between the ages of 18-85 undergoing diagnostic laboratory polysomnoagraphy being tested for the diagnosis of obstructive sleep apnoea.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient's with a known diagnosis of obstructive sleep apnoea undergoing a treatment sleep study
Participants unable to provide informed consent
Studies with a total sleep time of less than 4 hours

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Level of agreement for the primary and secondary outcomes will be determined utilising Bland-Altman plots.
A sample size of 100 will achieve a confidence interval for the 95% limits of agreement of +/-0.34s, where s is the standard deviation of the differences between measurements by the two methods (NightOwl and laboratory PSG). This is from the work by Bland and Altman (1986), 'Statistical methods for assessing agreement between two methods of clinical measurement', Lancet.
Comparison of categories of OSA severity by the two methods will be by chi-square and odds ratios.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/04/2021
Actual
Date of last participant enrolment
Anticipated
18/06/2021
Actual
Date of last data collection
Anticipated
18/06/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18733 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 33177 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 307891 0
Hospital
Name [1] 307891 0
Monash Medical Centre
Country [1] 307891 0
Australia
Primary sponsor type
Individual
Name
A/Prof Darren Mansfield
Address
Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Road
Clayton 3168
Victoria
Country
Australia
Secondary sponsor category [1] 308601 0
Hospital
Name [1] 308601 0
Monash Health
Address [1] 308601 0
Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Road
Clayton 3168
Victoria
Country [1] 308601 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307889 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 307889 0
Research Support Services
Level 2, iBlock,
Monash Medical Centre
246 Clayton Road,
CLAYTON VIC 3168
Ethics committee country [1] 307889 0
Australia
Date submitted for ethics approval [1] 307889 0
26/11/2020
Approval date [1] 307889 0
09/12/2020
Ethics approval number [1] 307889 0
RES-20-0000-702A

Summary
Brief summary
Obstructive sleep apnoea (OSA) is associated with increased risk of cardiovascular disease including hypertension, and screening for this condition and treatment may help reduce those risks. Furthermore, undiagnosed OSA is also linked to increased risk of postoperative complications in patients undergoing major surgery. Opportunities to screen using simplified diagnostic devices may be an important approach to addressing this clinical burden. Conventionally, the diagnosis of OSA is conducted by laboratory polysomnography (PSG) . A number of simplified devices are emerging commercially including single use disposable single or dual channel home monitoring. Single use disposable devices may emerge as the most convenient method for screening for OSA, especially in the home setting, however formal validation against PSG has not been previosly performed. The NightOwl is a small dual channel device that acquires data from a single fingertip and is now TGA registered as a single-use device in addition to a previously validated reusable option. The purpose of this study is to validate the single-use NightOwl compared to its reusable counterpart and the gold standard laboratory PSG for the diagnosis of OSA. Findings of this study will inform models of care that may include screening for OSA. This may be important in the clinical assessment of operative risk in those suspected of OSA undergoing major surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108834 0
Dr Christopher Lyne
Address 108834 0
Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 108834 0
Australia
Phone 108834 0
+61 3 9594 2900
Fax 108834 0
Email 108834 0
[email protected]
Contact person for public queries
Name 108835 0
Darren Mansfield
Address 108835 0
Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 108835 0
Australia
Phone 108835 0
+61 3 9594 2900
Fax 108835 0
Email 108835 0
[email protected]
Contact person for scientific queries
Name 108836 0
Darren Mansfield
Address 108836 0
Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 108836 0
Australia
Phone 108836 0
+61 3 9594 2900
Fax 108836 0
Email 108836 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
In line with our ethics approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10731Study protocol    381444-(Uploaded-17-02-2021-11-35-41)-Study-related document.docx
10732Ethical approval    381444-(Uploaded-17-02-2021-11-40-43)-Study-related document.pdf



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.