Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001293954
Ethics application status
Approved
Date submitted
8/09/2020
Date registered
30/11/2020
Date last updated
30/11/2020
Date data sharing statement initially provided
30/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Sonomat; A novel tool for evaluating sleep apnoea and breathing sounds in patients with interstitial lung disease (ILD)
Scientific title
Sonomat for detecting sleep apnoea in patients with interstitial lung disease (ILD): a novel screening tool in an at-risk population.
Secondary ID [1] 302151 0
Nil known
Universal Trial Number (UTN)
U1111-1257-4808
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial lung disease 318794 0
sleep disordered breathing 318795 0
sleep apnoea 318796 0
Condition category
Condition code
Respiratory 316811 316811 0 0
Other respiratory disorders / diseases
Respiratory 316812 316812 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
The Sonomat is a mat-based, non-contact recording system that can be used in the laboratory or the home. This device measures OSA and breathing/body movements, but it can also detect other lung sounds typically heard via a stethescope such as crackles and wheeze.
Research participants will be invited to consent to either 3 nights at home sleep studies using the Sonomat, or 1 night in-hospital polysomnography (PSG) sleep study, plus concomitant Sonomat study, followed by 3 nights at home sleep studies using the Sonomat.
Participants will be followed up for 12 months following initial sleep investigations (Sonomat, and a sub-set of participants with additional polysomnography). Disease severity indices including respiratory function tests and a 6-minute walk test, will be obtained at baseline, 6 and 12 months. The three (3) questionnaires (STOP-Bang, ESS and PSQI), lung function tests and 6 minute walk test will be repeated at 6- and 12-months following sleep studies.
Intervention code [1] 318453 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324924 0
% of participants with Sonomat apnea/hypopnea index (AHI) >/=15 events/hour
Timepoint [1] 324924 0
at baseline Sonomat study
Secondary outcome [1] 387810 0
Death or lung transplantation
Timepoint [1] 387810 0
12 months
Secondary outcome [2] 387812 0
Sonomat crackle time (%)
Timepoint [2] 387812 0
Baseline
Secondary outcome [3] 387813 0
Sonomat crackle latency (minutes)
Timepoint [3] 387813 0
Baseline
Secondary outcome [4] 387816 0
Sonomat wheeze time (%)
Timepoint [4] 387816 0
Baseline
Secondary outcome [5] 387817 0
Sonomat wheeze frequency (Hz)
Timepoint [5] 387817 0
Baseline
Secondary outcome [6] 387818 0
AHI on PSG
Timepoint [6] 387818 0
Baseline
Secondary outcome [7] 387819 0
Oxygen desaturation index assessed using polysomnogram
Timepoint [7] 387819 0
Baseline
Secondary outcome [8] 387820 0
Total sleep time assessed using polysomnogram
Timepoint [8] 387820 0
Baseline
Secondary outcome [9] 387821 0
Score for risk of obstructive sleep apnoea, assessed as 'low', 'intermediate' or 'high' using the STOP-bang questionnaire
Timepoint [9] 387821 0
baseline, 6 and 12 months
Secondary outcome [10] 387822 0
Pittsburgh Sleep quality index (PSQI)
Timepoint [10] 387822 0
Baseline, 6 and 12 months
Secondary outcome [11] 387823 0
Epworth sleepiness scale (ESS)
Timepoint [11] 387823 0
Baseline, 6 and 12 months
Secondary outcome [12] 387826 0
6 minute walk distance (6MWD)
Timepoint [12] 387826 0
at baseline, 6 months, 12 months
Secondary outcome [13] 387827 0
Forced Vital Capacity (FVC) % predicted assessed using spirometry
Timepoint [13] 387827 0
at baseline, 6 months, 12 months
Secondary outcome [14] 387832 0
Diffusion capacity % assessed using the single-breath technique
Timepoint [14] 387832 0
at baseline, 6 months, 12 months
Secondary outcome [15] 387833 0
Right ventricular systolic pressure on echocardiogram
Timepoint [15] 387833 0
at baseline and 12 months (where available)

Eligibility
Key inclusion criteria
Research participants will be recruited from a cohort of adult patients attending a tertiary specialist clinic with the diagnosis of fibrotic interstitial lung disease (ILD) (Royal Prince Alfred Hospital). Patients will be eligible for inclusion if they are 18 years of age or older, and have been diagnosed with ILD confirmed through multidisciplinary discussion, following international guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current CPAP or oxygen therapy use; known heart failure; bronchiectasis or chronic obstructive pulmonary disease; major psychiatric or neurological disorders; inability to provide informed consent or comply with the study requirements.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Group means ± standard deviations, and medians with interquartile ranges (IQR) will be calculated for baseline clinical and sleep data in both PSG and Sonomat studies.
The paired t-test will be used for comparison of normally distributed data from the PSG and Sonomat sleep studies.
Wilcoxon signed rank test will be used for non-normally distributed data.
Correlations between PSG and Sonomat variables, and between disease severity indices and Sonomat variables will be calculated using Spearman correlation coefficient.
Kappa statistic will be used to analyse agreement between the AHI yielded by the two testing modalities.
Univariate and multivariate logistic regression models will be constructed to evaluate the predictive power of Sonomat variables for disease outcomes.
Kaplan-Meier survival curves will also be constructed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/01/2021
Actual
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17337 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 31065 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 306578 0
Government body
Name [1] 306578 0
Sydney Local Health District
Country [1] 306578 0
Australia
Funding source category [2] 306969 0
Commercial sector/Industry
Name [2] 306969 0
Sonomedical Pty Ltd
Country [2] 306969 0
Australia
Primary sponsor type
Government body
Name
Sydney local health district
Address
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 307103 0
University
Name [1] 307103 0
University of Sydney
Address [1] 307103 0
75 East Street,
Lidcombe NSW 2141
Country [1] 307103 0
Australia
Other collaborator category [1] 281439 0
Commercial sector/Industry
Name [1] 281439 0
Sonomedical Pty Ltd
Address [1] 281439 0
10 Evans St,
Balmain
NSW 2041
Country [1] 281439 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306762 0
Sydney Local Health District Human Research Ethics Committee – CRGH
Ethics committee address [1] 306762 0
Building 20, Ground Floor,
Hospital Road,
Concord
NSW 2139
Ethics committee country [1] 306762 0
Australia
Date submitted for ethics approval [1] 306762 0
25/06/2020
Approval date [1] 306762 0
06/08/2020
Ethics approval number [1] 306762 0
2020/ETH01413

Summary
Brief summary
Thirty (30) research participants will undertake at-home Sonomat sleep studies, for 3 nights. Screening for sleep disordered breathing with preliminary STOP-Bang questionnaire, Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI) to take place prior to overnight testing. A subset of ten (10) will be referred for concomitant diagnostic PSG and Sonomat studies prior to the first at-home Sonomat recording, whilst breathing room air. This will take place within an outpatient technician-supervised sleep laboratory. Disease severity indices including respiratory function tests and a 6-minute walk test, will be obtained at baseline, 6 and 12 months. The three (3) questionnaires (STOP-Bang, ESS and PSQI), lung function tests and 6 minute walk test will be repeated at 6- and 12-months following sleep studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104934 0
Dr Maree Milross
Address 104934 0
Sydney School of Health Sciences,
Faculty of Medicine and Health,
University of Sydney,
75 East St,
Lidcombe,
NSW 2141
Country 104934 0
Australia
Phone 104934 0
+61 2 9351 9191
Fax 104934 0
Email 104934 0
[email protected]
Contact person for public queries
Name 104935 0
Dr Maree Milross
Address 104935 0
Sydney School of Health Sciences,
Faculty of Medicine and Health,
University of Sydney,
75 East St,
Lidcombe,
NSW 2141
Country 104935 0
Australia
Phone 104935 0
+61 2 9351 9191
Fax 104935 0
Email 104935 0
[email protected]
Contact person for scientific queries
Name 104936 0
Dr Maree Milross
Address 104936 0
Sydney School of Health Sciences,
Faculty of Medicine and Health,
University of Sydney,
75 East St,
Lidcombe,
NSW 2141
Country 104936 0
Australia
Phone 104936 0
+61 2 9351 9191
Fax 104936 0
Email 104936 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Derived and interpreted data will be made publicly available within a future publication and supplementary material. Any applications requesting data that underlies published results, for the purposes of meta-analysis, will be considered after HREC review.
When will data be available (start and end dates)?
Immediately following publication with no end date determined.
Available to whom?
Available on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Available for meta-analysis will be considered following application and HREC approval
How or where can data be obtained?
The corresponding author on publications can be notified with data sharing requests. This will be referred to the HREC for approval prior to data sharing.


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.