Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000322730
Ethics application status
Approved
Date submitted
5/10/2021
Date registered
21/02/2022
Date last updated
7/04/2024
Date data sharing statement initially provided
21/02/2022
Date results provided
21/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Classification of Obstructive Sleep Apnoea Severity using Snore and Breathing Sound Recordings in Adult Patients in a Home Setting – Validation with Simultaneous Home Based Polysomnography
Scientific title
Classification of Obstructive Sleep Apnoea Severity in Adults using Snore and Breathing Sound Recordings in Adult Patients in a Home Setting – Validation with Simultaneous Home Based Polysomnography
Secondary ID [1] 305461 0
Nil
Universal Trial Number (UTN)
Trial acronym
OSA_SNOREAPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 323840 0
Condition category
Condition code
Respiratory 321349 321349 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
Participants were approached by study staff and provided an explanation of the
study. Eligible and willing subjects were consented, and patients were allocated a Patient Study
Number (PSN). Following enrolment, subjects were required to complete standard sleep questionnaires and undergo the HBSS comprehensive sleep study (according to the standard CRS Sleep Lab protocol). Subjects completed all enrolment activities and snore/breathing recordings in a single, overnight visit. Participants were provided the smartphone Data was collected during an overnight sleep study (> 8 hours) on all consenting patients via simultaneous PSG and SleepCheck.

Snore and breathing sounds via smartphone were collected via various smart devices, including
an Apple iPhone 7. The smartphone was placed on the side table next to the bed. The
smartphone microphone (at the base of the phone) was oriented towards the subject in the bed) and the screen faced upwards towards the ceiling. The sound recording commenced when lights were turned out and ceased when the patient woke the following morning. Where possible, ambient noise was minimised.
The overnight sleep study occurred simultaneously with participants being given the questionnaires by a sleep physician and instructions on how to use the device overnight. Participants completed all enrolment activities and provided the device on a smartphone to record snore /breathing pattern overnight. The snore/breathing recordings were completed in a single, overnight visit. Data was collected during an overnight sleep study (> 8 hours) on all consenting patients via simultaneous PSG and SleepCheck.
Snore and breathing sounds via smartphone were collected via various smart devices, including
an Apple iPhone 7. These devices are battery operated (<5 volts) and did not have any physical
contact with the subjects. The smartphone was placed on the side table next to the bed. The
smartphone microphone (at the base of the phone) was oriented towards the subject in the bed)and the screen faced upwards towards the ceiling. The sound recording commenced when lights were turned out and ceased when the patient woke the following morning. Where possible,ambient noise was minimised. The study was completed overnight in the participants home environment.Overall duration of the study was overnight on a single night.
Intervention code [1] 321862 0
Early Detection / Screening
Intervention code [2] 321863 0
Diagnosis / Prognosis
Comparator / control treatment
The Snore App diagnosis will be compared to the standard-of-care clinical PSG sleep study diagnosis . Sleep apnoea is confirmed with a PSG sleep study.
Control group
Active

Outcomes
Primary outcome [1] 329134 0
The reference test was a PSG.
The primary efficacy endpoints of the study was sensitivity and specificity of the SleepCheck
(SnoreApp) algorithms to diagnose and rule out obstructive sleep apnoea (OSA) at three
Apnoea-Hypopnoea Index (AHI) diagnostic thresholds:
- AHI greater than or equal to 5/h (apnoea present)
- AHI greater than or equal to 15/h (moderate or severe); and
- AHI greater than or equal to 30/h (severe)
for subjects undergoing a simultaneous At-Home sleep study using a Type II PSG (HBSS), and
who are sleeping by themselves when there are no other people or pets in the room.
Timepoint [1] 329134 0
End of the study (when all participant data has been collected)
Secondary outcome [1] 404146 0
Secondary efficacy endpoints included calculation of:
• Positive Predictive Value (PPV)
• Negative Predictive Value (NPV)
Timepoint [1] 404146 0
End of the study (when all participant data has been collected)

Eligibility
Key inclusion criteria
Anyone aged over 18 years with the principal diagnosis of suspected sleep disordered breathing or insomnia referred for a diagnostic sleep study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of a signed consent form.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A total of 308 subjects were recruited

The primary endpoints are sensitivity and specificity of the SleepCheck algorithms to diagnose and rule out obstructive sleep apnoea (OSA) at three diagnostic thresholds, AHI greater than or equal to 5/h, AHI greater than or equal to 15/h and AHI greater than or equal to 30/h for patients undergoing a simultaneous at-home sleep study using a Type II PSG and who are sleeping by themselves when there are no other people or pets in the room.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/09/2018
Date of last participant enrolment
Anticipated
Actual
20/09/2019
Date of last data collection
Anticipated
Actual
20/09/2019
Sample size
Target
308
Accrual to date
Final
308
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20657 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 35447 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 309819 0
Commercial sector/Industry
Name [1] 309819 0
ResApp Health Ltd
Country [1] 309819 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResApp Health Ltd
Address
Level 12, 100 Creek Street
Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 310855 0
None
Name [1] 310855 0
Address [1] 310855 0
Country [1] 310855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309562 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 309562 0
Ethics committee country [1] 309562 0
Australia
Date submitted for ethics approval [1] 309562 0
18/04/2017
Approval date [1] 309562 0
09/05/2017
Ethics approval number [1] 309562 0
HPH493

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

Contacts
Principal investigator
Name 114598 0
Dr Phillip Currie
Address 114598 0
Cardio Respiratory Sleep (CRS), Hollywood Specialist Centre, Suite 13/95 Monash Ave, Nedlands WA 6009
Country 114598 0
Australia
Phone 114598 0
+61 416112754
Fax 114598 0
Nil
Email 114598 0
[email protected]
Contact person for public queries
Name 114599 0
Neroli Anderson
Address 114599 0
ResApp Health Ltd
Level 12 , 100 Creek Street
Brisbane Australia Q4000
Country 114599 0
Australia
Phone 114599 0
+61 416220239
Fax 114599 0
nil
Email 114599 0
[email protected]
Contact person for scientific queries
Name 114600 0
Tony Keating
Address 114600 0
ResApp Health Ltd
Level 12 100 Creek Street
Brisbane 4000
Australia
Country 114600 0
Australia
Phone 114600 0
+61 430180659
Fax 114600 0
Nil
Email 114600 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


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.