Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000804482
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
28/07/2025
Date last updated
28/07/2025
Date data sharing statement initially provided
28/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
SMART-OSA Pilot Study: A Sensor Mat for the Assessment and Remote monitoring of Treatment response in Obstructive Sleep Apnea within primary care
Scientific title
A Pilot Study to Evaluate the Utility of the Withings Under-Mattress Sensor and Smart Monitoring System for the Diagnosis and Management of Obstructive Sleep Apnea within Primary Care
Secondary ID [1] 314059 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SMART-OSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 336807 0
Condition category
Condition code
Respiratory 333300 333300 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Withings Sleep Analyser (WSA) is a cheap, commercially available, simple-to-use, sleep monitoring device placed under a patient’s mattress (no direct contact needed) which uses a machine-learning algorithm to integrate snoring, breathing patterns, body movements and heart rate to estimate sleep duration and number of obstructed breathing events per hour of sleep (apnea-hypopnea index [AHI]).

The WSA has the following potential advantages over PSG and limited-channel sleep testing devices such as the ApneaLink:
1) It can remain under a patient’s mattress for prolonged time periods, enabling multi-night monitoring and ability to address problems with night-to-night variability in OSA presence and severity compared to a single-night PSG or ApneaLink test;
2) Enable monitoring of residual AHI after therapy-initiation for OSA;
3) Can be used with the Withings smart blood pressure monitor, weight scales and mobile phone app to enable long-term monitoring and management of comorbidities associated with OSA, e.g. hypertension and obesity, by patients and GPs.

All patients in the study will undergo concurrent single-night full polysomnography (PSG), single-night level 3 (ApneaLink) testing (which has previously been validated by the investigators for investigation of suspected OSA in primary care) and 7 nights of WSA monitoring to assess diagnostic accuracy and impact of night-to-night variability on OSA management by GPs..

Patients in the intervention arm (n=10) will be managed by their GP using data from the Withings mat only (mean AHI>=20 events/hr to confirm moderate-severe OSA), and be blinded from ApneaLink and full PSG data until the end of the follow-up period. They will continue to use the WSA mat under their mattress, be issued with a Withings smart blood pressure monitor and scales to undertake weekly recordings of their blood pressure and weight, and be asked to download the Withings mobile phone app to enable ongoing monitoring and feedback for a total of 3 months follow-up by their GP and a practice nurse within primary care. The smart blood pressure monitor will be self-applied by the participant to their upper arm once a week (similar to automated blood pressure cuffs in GP clinics), according to standard instructions provided by Withings, and measurements uploaded to the cloud via the patient's home WiFi connection. Information from the WSA, blood pressure monitor and weight scales will be displayed to the participant on a Withings mobile phone app, providing data on nightly sleep duration, residual sleep apnea events, and weekly blood pressure and weight. Adherence to the intervention will be assessed via data provided by the Withings smart system, as well as collection of CPAP download information at the end of the follow-up period if CPAP was used by the participant during the study.
Intervention code [1] 330639 0
Diagnosis / Prognosis
Intervention code [2] 330640 0
Treatment: Devices
Comparator / control treatment
Diagnosis and management of suspected obstructive sleep apnea using data from a single-night level 3 limited-channel sleep study device (ApneaLink, ResMed), which has previously been validated for use in primary care by the chief investigator of this trial (ACTRN12608000514303).
Control group
Active

Outcomes
Primary outcome [1] 340875 0
Subjective daytime sleepiness
Timepoint [1] 340875 0
Baseline at time of PSG and 3 months post-PSG
Primary outcome [2] 340876 0
Diagnostic accuracy of Withings Sleep Analyser (WSA)
Timepoint [2] 340876 0
Baseline after PSG and after 7 days of WSA monitoring
Secondary outcome [1] 445320 0
Disease-specific quality of life
Timepoint [1] 445320 0
Baseline at time of PSG and 3 months post-PSG
Secondary outcome [2] 445321 0
Depression
Timepoint [2] 445321 0
Baseline at time of PSG and 3 months post-PSG
Secondary outcome [3] 445322 0
Anxiety
Timepoint [3] 445322 0
Baseline at time of PSG and 3 months post-PSG
Secondary outcome [4] 445323 0
Body mass index
Timepoint [4] 445323 0
Baseline at time of PSG and 3 months post-PSG
Secondary outcome [5] 445324 0
Waist circumference
Timepoint [5] 445324 0
Baseline at time of PSG and 3 months post-PSG
Secondary outcome [6] 445325 0
Blood pressure
Timepoint [6] 445325 0
Baseline at time of PSG and 3 months post-PSG
Secondary outcome [7] 445326 0
CPAP adherence
Timepoint [7] 445326 0
3 months post-PSG
Secondary outcome [8] 445328 0
Adequacy of OSA therapy
Timepoint [8] 445328 0
3 months post-PSG
Secondary outcome [9] 445329 0
Patient satisfaction with sleep study equipment
Timepoint [9] 445329 0
3 months post-PSG
Secondary outcome [10] 445330 0
General quality of life
Timepoint [10] 445330 0
Baseline at time of PSG and 3 months post-PSG
Secondary outcome [11] 449813 0
Patient experience with care provided
Timepoint [11] 449813 0
3 months post-PSG

Eligibility
Key inclusion criteria
1) Patients aged 18 years or above from primary care clinic who are at high risk of symptomatic, moderate-severe OSA, i.e. OSA50 questionnaire score greater than or equal to 5/10 and Epworth Sleepiness Scale (ESS) greater than or equal to 8/24;
2) Willing to use CPAP therapy if found to have moderate-severe OSA;
3) Wi-Fi capability within the home environment and able/willing to use mobile phone app for Withings devices;
4) Suitable bedroom environment and stable sleeping arrangements (e.g. able to place WSA under their mattress, plans to sleep in same bed almost all nights, no pets on bed).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients previously investigated and/or treated for OSA;
2) Pregnant women;
3) Unstable psychiatric disease or cognitive impairment considered likely to interfere with provision of informed consent, adherence to instructions, completing the study and/or managing CPAP;
4) Severe morbid obesity (body mass index [BMI] greater than or equal to 50);
5) Neuromuscular disease;
6) Hospitalization in the previous 3 months for myocardial infarction, unstable angina, cardiac failure, or cerebrovascular accident, or New York Heart Association class III or IV symptoms;
7) Lung disease with awake resting oxygen saturation less than 92% or requiring supplemental oxygen therapy;
8) Commercial or heavy vehicle driver.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of OSA measures from the Withings Sleep Analyser (AHI) with Home PSG (AHI) and ApneaLink device (AHI and 3%ODI) will be undertaken using Bland-Altman analyses, receiver operating characteristic area under curve analyses, and measures of sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios and overall diagnostic accuracy of the WSA to detect moderate-severe OSA (i.e. WSA AHI greater than or equal to 20/hr against PSG AHI greater than or equal to 20/hr and ApneaLink 3%ODI greater than or equal to 16/hr).

Differences between Withings and ApneaLink arms in the mean change in ESS, FOSQ-10, EQ-5D-5L, BMI, waist circumference, blood pressure, PHQ-9 and GAD-7 from baseline to 3 months will be assessed using analysis of covariance with adjustment for baseline scores, and group differences in CPAP acceptance rates, mean nightly CPAP use and patient satisfaction/experience at 3 months will be assessed using independent sample Student t-tests (parametric data), Wilcoxin sum rank tests (non-parametric data) or chi-square tests (for proportions) where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318565 0
Charities/Societies/Foundations
Name [1] 318565 0
Flinders Foundation
Country [1] 318565 0
Australia
Funding source category [2] 318567 0
University
Name [2] 318567 0
Flinders University
Country [2] 318567 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320966 0
None
Name [1] 320966 0
Address [1] 320966 0
Country [1] 320966 0
Other collaborator category [1] 283451 0
Other Collaborative groups
Name [1] 283451 0
Chandlers Hill Surgery (Primary Care Clinic)
Address [1] 283451 0
Country [1] 283451 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317168 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 317168 0
Ethics committee country [1] 317168 0
Australia
Date submitted for ethics approval [1] 317168 0
28/03/2024
Approval date [1] 317168 0
06/08/2024
Ethics approval number [1] 317168 0
2024/HRE00045

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

Contacts
Principal investigator
Name 140222 0
A/Prof Ching Li Chai-Coetzer
Address 140222 0
Adelaide Institute for Sleep Health: FHMRI Sleep Health, Flinders University Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park SA 5042, AUSTRALIA
Country 140222 0
Australia
Phone 140222 0
+61 8 7221 8313
Fax 140222 0
Email 140222 0
[email protected]
Contact person for public queries
Name 140223 0
Ching Li Chai-Coetzer
Address 140223 0
Adelaide Institute for Sleep Health: FHMRI Sleep Health, Flinders University Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park SA 5042, AUSTRALIA
Country 140223 0
Australia
Phone 140223 0
+61 8 7221 8313
Fax 140223 0
Email 140223 0
[email protected]
Contact person for scientific queries
Name 140224 0
Ching Li Chai-Coetzer
Address 140224 0
Adelaide Institute for Sleep Health: FHMRI Sleep Health, Flinders University Mark Oliphant Building, Level 2, 5 Laffer Drive, Bedford Park SA 5042, AUSTRALIA
Country 140224 0
Australia
Phone 140224 0
+61 8 7221 8313
Fax 140224 0
Email 140224 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.