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Sonomat; A novel tool for evaluating sleep apnoea and breathing sounds in patients with interstitial lung disease (ILD)

Sonomat for detecting sleep apnoea in patients with interstitial lung disease (ILD): a novel screening tool in an at-risk population.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620001293954
Enrollment
30
Registered
2020-11-30
Start date
2021-01-25
Completion date
2021-12-01
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Sydney local health district
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026