ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12623000164695p

Ethics application status

Submitted, not yet approved

Date submitted

31/01/2023

Date registered

17/02/2023

Date last updated

17/02/2023

Date data sharing statement initially provided

17/02/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Finger and wrist worn peripheral arterial tonometry (WatchPAT) compared to a home-based sleep study for the diagnosis of obstructive sleep apnoea

Scientific title

Peripheral Arterial Tonometry based Home Sleep Apnoea Testing compared to Home Polysomnography for the diagnosis of obstructive sleep apnoea

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1287-5070

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

Study procedures:
All participants have standard home full PSG montage using Somte PSG (Compumedics™). WatchPAT 300 is simultaneously worn on the opposite finger and wrist to the oximeter probe from the home PSG.

Both Watch-PAT and home PSG will be worn together while the participant is sleeping overnight (minimum 4 hours overnight)

Both devices removed upon waking and returned to the Sleep Centre the following morning as per standard practice

Home PSG staged and scored using Compumedics Profusion PSG according to American Academy of Sleep Medicine (AASM) criteria (recommended) by the experienced local academic centre by scorers, blinded to WatchPAT results. This will be used by the clinical services for patient care.

All PSG raw data also transferred securely to Monash Sleep Centre, Monash Health for blinded analysis for 2nd staging and scoring by a single individual scorer

WatchPAT data uploaded to CloudPAT™ data analysis platform and analysed using autoscoring algorithm

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

The comparator is home based polysomnography which standard care for the patients. This is an observational study. All subjects will have a routine home polysomnogram which will be used by their clinicians for the diagnosis of obstructive sleep apnoea. The WatchPAT data will be simultaneously recorded and subsequently compared to home polysomnography but will not be used by the treating clinicians.

Control group

Active

Outcomes

Primary outcome [1]

4-way AHI severity classification (none, mild, moderate, severe) comparing data from WatchPAT to Home Polysomnography using contingency tables and percent raw agreement, and subsequently Cohen’s kappa, which takes into account the level of chance agreement.

Timepoint [1]

After one overnight sleep study

Secondary outcome [1]

Apnoea-Hypopnoea Index (AHI) agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [1]

After one overnight sleep study

Secondary outcome [2]

Oxygen Desaturation Index (ODI3%) agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [2]

After one overnight sleep study

Secondary outcome [3]

Time spent with SpO2 less than 90% agreement using the Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [3]

After one overnight sleep study

Secondary outcome [4]

Total sleep time (TST) agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [4]

After one overnight sleep study

Secondary outcome [5]

% REM sleep agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [5]

After one overnight sleep study

Secondary outcome [6]

% NREM sleep agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [6]

After one overnight sleep study

Secondary outcome [7]

Sensitivity for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 10/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [7]

After one overnight sleep study

Secondary outcome [8]

Sensitivity for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 15/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [8]

After one overnight sleep study

Secondary outcome [9]

Sensitivity for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 20/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [9]

After one overnight sleep study

Secondary outcome [10]

Specificity for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 10/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [10]

After one overnight sleep study

Secondary outcome [11]

Specificity for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 15/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [11]

After one overnight sleep study

Secondary outcome [12]

Specificity for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 20/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [12]

After one overnight sleep study

Secondary outcome [13]

Positive predictive value for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 10/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [13]

After one overnight sleep study

Secondary outcome [14]

Positive predictive value for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 15/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [14]

After one overnight sleep study

Secondary outcome [15]

Positive predictive value for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 20/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [15]

After one overnight sleep study

Secondary outcome [16]

Negative predictive value for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 10/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [16]

After one overnight sleep study

Secondary outcome [17]

Negative predictive value for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 15/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [17]

After one overnight sleep study

Secondary outcome [18]

Negative predictive value for WatchPAT to diagnose OSA at a threshold of AHI greater than or equal to 20/hour between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [18]

After one overnight sleep study

Secondary outcome [19]

Correlation co-efficient for Apnoea-Hypopnoea Index (AHI) between WatchPAT AHI and Home Polysomnography AHI assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [19]

After one overnight sleep study

Secondary outcome [20]

Correlation co-efficient for Oxygen Desaturation Index (ODI3%) between WatchPAT ODI3% and Home Polysomnography ODI3% assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [20]

After one overnight sleep study

Secondary outcome [21]

Correlation co-efficient for Total Sleep Time (TST) between WatchPAT TST and Home Polysomnography TST assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [21]

After one overnight sleep study

Secondary outcome [22]

Correlation co-efficient for %REM sleep between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [22]

After one overnight sleep sleep study

Secondary outcome [23]

Correlation co-efficient for %NREM sleep between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [23]

After one overnight sleep study

Secondary outcome [24]

% supine sleep agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [24]

After one overnight sleep study

Secondary outcome [25]

Correlation co-efficient for %supine sleep between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography

Timepoint [25]

After one overnight sleep study

Secondary outcome [26]

Diagnostic classification agreement using Apnoea Hypopnoea Index (AHI) between Home PSG and WatchPAT with Near Boundary Double-Labelling of OSA severity classification (method of Van Peet et al, Sleep, 2022)

Timepoint [26]

After one overnight sleep study

Eligibility

Key inclusion criteria

All consecutive patients age greater than or equal to 18 undergoing home PSG for assessment of snoring or suspected OSA

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Investigation for disorders other than OSA
• Inability to consent
• Cognitive or physical impairment which would prevent adequate test performance (laboratory PSG performed instead)
• < 4 hours sleep time on Home PSG
• < 4 hours adequate airflow or oximetry signal on Home PSG

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Based on the 4-way diagnostic severity classification performance of WatchPAT vs Laboratory PSG, we conservatively assume a diagnostic category discordant rate of up to 50%. Therefore, to detect a 10% difference in the prevalence of moderate/severe OSA between WatchPAT and HomePSG, with 80% power and alpha 0.05, required n equals 392. Allowing for a dropout/data loss rate of 10% this increases the number of participants required to 431. We therefore plan to recruit n equals 450 to cater for any higher than predicted dropout rate.

Primary analysis:
• 4-way AHI severity classification (none, mild, moderate, severe) comparing WatchPAT to Home PSG with raw agreement and Cohen’s kappa

Secondary analysis:
• Agreement using Bland-Altman plots for AHI, ODI3%, time spent with SpO2 less than 90%, TST, %REM sleep and %NREM sleep
• Sensitivity/specificity/PPV/NPV for WatchPAT to diagnose OSA at different thresholds (AHI greater than or equal to 10/hr, 15/hr and 20/hr)
• Correlation co-efficient for AHI, ODI3%, TST, %REM sleep, %NREM sleep, %supine sleep for WatchPAT vs Home PSG
• Near Boundary Double-Labelling of OSA severity classification (method of Van Peet et al, Sleep, 2022; (https://doi.org/10.1093/sleep/zsac028) – allows assigning of individuals with AHI within a pre-defined boundary zone to 2 different categories of severity (e.g. AHI of 14 = “mild” and “moderate”, AHI of 6 = “mild” and “normal”). Allows for more clinically relevant comparison between Home PSG and WatchPAT when AHI is near standard OSA severity cut-offs
• Comparison of 4-way severity classification for WatchPAT vs Home PSG, to Interscorer reliability for home PSG (i.e WatchPAT to PSG human scorer 1 compared to human scorer 2)

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/05/2023

Actual

Date of last participant enrolment

Anticipated

1/05/2024

Actual

Date of last data collection

Anticipated

2/05/2024

Actual

Sample size

Target

450

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

SA,VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [3]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Itamar Medical

Address [1]

Itamar Medical Ltd, 9 Halamish Street, Caesarea, 3088900, Israel

Country [1]

Israel

Primary sponsor type

Hospital

Name

Monash Health

Address

246 Clayton Road, Clayton, Victoria, 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Monash Health, 246 Clayton Road Clayton, Victora, 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/01/2023

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Laboratory polysomnography (PSG) is costly and labour intensive and therefore cannot adequately deal with the large burden of Obstructive sleep apnoea (OSA) in the community. With technological developments there has been a global trend to home-based sleep testing, both with full PSG at home and limited channel home sleep apnoea testing (HSAT) devices, in order reduce the cost and increase the access to OSA diagnosis. The WatchPAT is a simplified, wrist and finger worn device, which measures peripheral arterial tonometry (PAT), a marker of autonomic tone. WatchPAT and similar devices can measure oxygen saturation and from the PAT signal derive measures of sleep staging and sleep apnoea severity. The WatchPAT is in common clinical use and has been validated against laboratory PSG, but there is limited validation against home based PSG in a general sleep clinic population. This multicentre study aims to assess the diagnostic accuracy of the WatchPAT compared to home based polysomnography in sleep clinic patients referred for the diagnosis of OSA.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Garun Hamilton

Address

Department of Lung, Sleep, Allergy and Immunology
Monash Health
246 Clayton Road
Clayton, Victoria, 3168

Country

Australia

Phone

+61 3 9594 2284

Fax

[email protected]

Contact person for public queries

Name

Daniel Habteslassie

Address

Department of Lung, Sleep, Allergy and Immunology
Monash Health
246 Clayton Road
Clayton, Victoria, 3168

Country

Australia

Phone

+61 3 9594 2900

Fax

[email protected]

Contact person for scientific queries

Name

Garun Hamilton

Address

Department of Lung, Sleep, Allergy and Immunology
Monash Health
246 Clayton Road
Clayton, Victoria, 3168

Country

Australia

Phone

+61 3 9594 2900

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

At the conclusion of the trial, de-identified individual patient data will be provided to Itamar Medical who are providing funding for the study

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18133	Study protocol					385282-(Uploaded-25-01-2023-16-35-37)-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.

Trial Review

Documents added manually

Documents added automatically