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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] 308830 0
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 328787 0
Condition category
Condition code
Respiratory 325797 325797 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
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] 325276 0
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] 333641 0
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] 333641 0
After one overnight sleep study
Secondary outcome [1] 417840 0
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] 417840 0
After one overnight sleep study
Secondary outcome [2] 417842 0
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] 417842 0
After one overnight sleep study
Secondary outcome [3] 418490 0
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] 418490 0
After one overnight sleep study
Secondary outcome [4] 418491 0
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] 418491 0
After one overnight sleep study
Secondary outcome [5] 418492 0
% REM sleep agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography
Timepoint [5] 418492 0
After one overnight sleep study
Secondary outcome [6] 418493 0
% NREM sleep agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography
Timepoint [6] 418493 0
After one overnight sleep study
Secondary outcome [7] 418494 0
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] 418494 0
After one overnight sleep study
Secondary outcome [8] 418495 0
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] 418495 0
After one overnight sleep study
Secondary outcome [9] 418496 0
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] 418496 0
After one overnight sleep study
Secondary outcome [10] 418497 0
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] 418497 0
After one overnight sleep study
Secondary outcome [11] 418498 0
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] 418498 0
After one overnight sleep study
Secondary outcome [12] 418499 0
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] 418499 0
After one overnight sleep study
Secondary outcome [13] 418500 0
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] 418500 0
After one overnight sleep study
Secondary outcome [14] 418501 0
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] 418501 0
After one overnight sleep study
Secondary outcome [15] 418502 0
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] 418502 0
After one overnight sleep study
Secondary outcome [16] 418503 0
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] 418503 0
After one overnight sleep study
Secondary outcome [17] 418504 0
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] 418504 0
After one overnight sleep study
Secondary outcome [18] 418505 0
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] 418505 0
After one overnight sleep study
Secondary outcome [19] 418506 0
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] 418506 0
After one overnight sleep study
Secondary outcome [20] 418507 0
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] 418507 0
After one overnight sleep study
Secondary outcome [21] 418508 0
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] 418508 0
After one overnight sleep study
Secondary outcome [22] 418509 0
Correlation co-efficient for %REM sleep between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography
Timepoint [22] 418509 0
After one overnight sleep sleep study
Secondary outcome [23] 418510 0
Correlation co-efficient for %NREM sleep between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography
Timepoint [23] 418510 0
After one overnight sleep study
Secondary outcome [24] 418511 0
% supine sleep agreement using Bland-Altman plots between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography
Timepoint [24] 418511 0
After one overnight sleep study
Secondary outcome [25] 418512 0
Correlation co-efficient for %supine sleep between WatchPAT and Home Polysomnography assessed from data extracted from WatchPAT and Home Polysomnography
Timepoint [25] 418512 0
After one overnight sleep study
Secondary outcome [26] 418513 0
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] 418513 0
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?
No
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] 23878 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 23879 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 23880 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 39343 0
3168 - Clayton
Recruitment postcode(s) [2] 39344 0
3084 - Heidelberg
Recruitment postcode(s) [3] 39345 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 313055 0
Commercial sector/Industry
Name [1] 313055 0
Itamar Medical
Country [1] 313055 0
Israel
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road, Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 314742 0
None
Name [1] 314742 0
Address [1] 314742 0
Country [1] 314742 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312307 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 312307 0
Ethics committee country [1] 312307 0
Australia
Date submitted for ethics approval [1] 312307 0
17/01/2023
Approval date [1] 312307 0
Ethics approval number [1] 312307 0

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

Contacts
Principal investigator
Name 124186 0
Prof Garun Hamilton
Address 124186 0
Department of Lung, Sleep, Allergy and Immunology
Monash Health
246 Clayton Road
Clayton, Victoria, 3168
Country 124186 0
Australia
Phone 124186 0
+61 3 9594 2284
Fax 124186 0
Email 124186 0
garun.hamilton@monashhealth.org
Contact person for public queries
Name 124187 0
Daniel Habteslassie
Address 124187 0
Department of Lung, Sleep, Allergy and Immunology
Monash Health
246 Clayton Road
Clayton, Victoria, 3168
Country 124187 0
Australia
Phone 124187 0
+61 3 9594 2900
Fax 124187 0
Email 124187 0
Daniel.Habteslassie@monashhealth.org
Contact person for scientific queries
Name 124188 0
Garun Hamilton
Address 124188 0
Department of Lung, Sleep, Allergy and Immunology
Monash Health
246 Clayton Road
Clayton, Victoria, 3168
Country 124188 0
Australia
Phone 124188 0
+61 3 9594 2900
Fax 124188 0
Email 124188 0
garun.hamilton@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
18133Study protocol    385282-(Uploaded-25-01-2023-16-35-37)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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