Apneal

Improving obstructive sleep apnoea diagnosis

The challenge

We spend approximately one-third of our lives sleeping. Obstructive sleep apnoea syndrome (OSA) is one of the most prevalent sleep disorders, affecting up to 21% of women and 31% of men worldwide.[1]

Severe OSA is associated with increased all-cause mortality.[2] Other adverse health outcomes associated with untreated OSA include cardiovascular disease and cerebrovascular events, type 2 diabetes, cognitive impairment, decreased quality of life, and motor vehicle crashes.[3]

Only 20% of OSA cases are diagnosed or treated.[4] OSA under-diagnosis is due to several factors including ineffective screening, fragmented care pathways and long waiting times.

OSA is diagnosed through sleep studies, usually conducted by certified sleep specialists. There are two types. One type is an overnight polysomnography performed in the sleep lab centre. The other type can be carried out at home using a portable monitor, which costs less and shortens waiting times. However, a negative result on this second time may necessitate a full overnight polysomnography.

Waiting times for sleep apnoea diagnosis vary globally due to demand exceeding capacity. In many countries, patients may wait for months before receiving a diagnosis. Meanwhile, sleep tests are often performed on individuals who are not eligible for treatment, resulting in the waste of valuable diagnostic resources.

The solution

Mitral, the start-up leading the Apneal project team, and their partners addresses this challenge by providing an effective new solution to diagnose OSA which is faster and cheaper than current methods. The team has created a simple AI-based sleep apnoea screening tool that uses a patient’s common smartphone comfortably taped on the pyjamas overnight.

Their solution is a product called Apneal which is user-friendly, cost-effective and requires no training, investment, logistics or hardware. It enables existing diagnostics resources to focus on high probability OSA patients, resulting in increased diagnosis and treatment for OSA via an optimised screening and diagnosis pathway.

The smartphone’s sensors record chest movements, heartbeats, and breathing sounds. Apneal’s proprietary and innovative artificial intelligence algorithms detect cardio-respiratory events and estimate AHI to determine next steps: ruling out OSA or moving forward with simplified or advanced diagnosis exams based on report data and patient phenotype. The whole process takes 24 hours.

Compared to other solutions for screening OSA, Apneal presents a great advantage of not using any hardware apart from the patient’s smartphone, which leads it to be cheaper and easier to use. While still obtaining similar performance than other solutions that do use external hardware.

With Apneal, patients will be able to rapidly test themselves for OSA in the comfort of their own home and can listen to audio recordings of their own pathological symptoms, such as snoring and breathing disturbances, which motivates them to continue the medical pathway.

The project team plans to bring Apneal to the market as a class IIa software medical device while preparing data and strategy to get reimbursement in European countries. Thanks to EIT Health support, the team will gather evidence to obtain the CE marking and reimbursement for the Apneal solution. The team is conducting a European multi-centric clinical study in accordance with the Medical Device Regulation in seven different investigator centres.

Expected impact

Mitral, the start-up leading the Apneal project, plans to define a new standard of care for sleep apnoea screening management based on scientific evidence and clinical data gathered in the project. It is expected in that the implementation and integration of OSA screening programmes using Apneal into clinical practice will positively affect all stakeholders.

Patients experiencing long-term symptoms of sleep apnoea will promptly access diagnostic tests to identify appropriate treatment options. Sleep specialists will involve primary care practitioners or General Practitioners for the patients who complain about related symptoms to make qualified referrals by using tools that ensure the triage or prioritisation of patients who are at higher risk.

First line physicians will have better awareness, education, support, and tools to enlarge screening at their level. The solution also promises to have a positive impact for payers as it promises to decrease healthcare utilisation and cost following the diagnosis of treatment of OSA.

The team also plans to launch educational activities to raise awareness of sleep apnoea among first-line physicians and promote best practices in its management. The goal is to create a network of informed healthcare professionals to help achieve Apneal’s mission.

Project Leaders

• Mitral

External Partners

• Digital Medical Hub
• Ethik IA
• Health Proof Helsinki

References

[1] Ferrie, J.E. et al. Sleep epidemiology—a rapidly growing field. Int J Epidemiol. 2011; 40(6): 1431-7.

[2] Balk, E.M. et al. (2011) Diagnosis and treatment of obstructive sleep apnea in adults [internet], National Center for Biotechnology Information. Available at: https://pubmed.ncbi.nlm.nih.gov/21977519/ (Accessed: 16 April 2024).

[3] Knauert, M. et al. (2015) Clinical consequences and economic costs of untreated obstructive sleep apnea syndrome, World journal of otorhinolaryngology – head and neck surgery. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698527/ (Accessed: 16 April 2024).

[4] (2017) AASM. Available at: https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf (Accessed: 16 April 2024).