ANZCTR - Registration

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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]

N/A

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obstructive sleep apnoea

Condition category

Condition code

Respiratory

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]

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]

Level of agreement between apnoea-hypopnoea index obtained from the single-use NightOwl sleep testing system and the gold standard laboratory polysomnography

Timepoint [1]

At the time of the sleep study

Primary outcome [2]

Level of agreement between apnoea-hypopnoea index obtained from the multi-use NightOwl sleep testing system and the gold standard laboratory polysomnography

Timepoint [2]

At the time of the sleep study

Secondary outcome [1]

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]

At the time of the sleep study

Secondary outcome [2]

Level of agreement between total sleep time obtained from the single-use NightOwl sleep test system and the gold standard laboratory polysomnography

Timepoint [2]

At the time of the sleep study

Secondary outcome [3]

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]

At the time of the sleep study

Secondary outcome [4]

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]

At the time of the sleep study

Secondary outcome [5]

Level of agreement between total sleep time obtained from the multi-use NightOwl sleep test system and the gold standard laboratory polysomnography

Timepoint [5]

At the time of the sleep study

Secondary outcome [6]

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]

At the time of the sleep study

Secondary outcome [7]

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]

At the time of the sleep study

Secondary outcome [8]

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]

At the time of the sleep study

Secondary outcome [9]

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]

At the time of the sleep study

Secondary outcome [10]

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]

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Medical Centre

Address [1]

Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Road
Clayton 3168
Victoria

Country [1]

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]

Hospital

Name [1]

Monash Health

Address [1]

Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Road
Clayton 3168
Victoria

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Research Support Services
Level 2, iBlock,
Monash Medical Centre
246 Clayton Road,
CLAYTON VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/11/2020

Approval date [1]

09/12/2020

Ethics approval number [1]

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

Dr Christopher Lyne

Address

Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 2900

Fax

Email

[email protected]

Contact person for public queries

Name

Darren Mansfield

Address

Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 2900

Fax

Email

[email protected]

Contact person for scientific queries

Name

Darren Mansfield

Address

Monash Lung Sleep Allergy and Immunology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 2900

Fax

Email

[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.	Type	Citation	Link	Email	Other Details	Attachment
10731	Study protocol					381444-(Uploaded-17-02-2021-11-35-41)-Study-related document.docx
10732	Ethical 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.