None listed
Conditions
Brief summary
This project is a pilot study to evaluate whether a contactless Withings sensor mat placed under a patient’s mattress, combined with ‘smart’ blood pressure monitoring, weight scales and a mobile phone app, could be part of a more simple and cost-effective diagnosis and treatment strategy for patients with suspected obstructive sleep apnea (OSA) when used by GPs and practice nurses in the primary care setting. We aim to recruit 20 patients from primary care who are at high risk of OSA who will undergo concurrent single-night full PSG, single-night limited-channel ApneaLink study and 7-night Withings under-mattress sensor mat monitoring, followed by randomisation into either diagnosis and management by their GP using results from the previously-validated limited-channel ApneaLink study (ACTRN12608000514303) versus 7 nights of monitoring using the Withings under-matress sensor and ongoing smart monitoring for 3 months follow-up to assess: (1) the diagnostic accuracy of the Withings sensor for identifying clinically significant OSA, (2) night-to-night variability in OSA parameters; and (3) clinical effectiveness of using the Withings smart system for OSA management.
Interventions
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
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.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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.
Outcome results
None listed