Outpatient solution that improves the diagnosis of REM sleep disorder

We have created an outpatient solution that improves the diagnosis of REM sleep disorder

Sleep disorder is a silent pathology. TECNALIA's Health team is researching REM Sleep Behaviour Disorder (RBD), characterised by the presence of vigorous behaviour and the lack of muscle atonia during the REM phase, leading to vivid dreams usually occurring in the second half of the night.

When was the last time you had a good night's sleep? And not just enough hours, but rather restful, deep and peaceful sleep.

• More than 80 % of patients with REM RBD develop some type of neurodegenerative pathology within ten years of diagnosis, according to experts from the Spanish Sleep Society (SSS).
• Early, outpatient diagnosis is considered an unresolved medical need and a priority objective.
• The development of a Smart Portable Monitoring System for REM Sleep Disorders (SMOTTS Project ) arises from this need.

An innovative portable system for outpatient use

SMOTTS will enhance the diagnosis of REM RBD patients by integrating information from the patient’s different physiological signals into a machine learning and smart diagnosis system that will provide clinical specialists with well-informed clinical criteria to assist them in the diagnostic task.

Furthermore, it is proposed that the system is used on an outpatient basis, which is a major advantage and new feature compared with existing equipment, reducing the pressure on hospital sleep units and reducing diagnosis times, as well as improving the quality of the diagnosis by being able to study the patient in his or her usual resting environment.

This work developed by the TECNALIA Health team, along with the University of Malaga, the Biomedical Research Institute of Malaga (IBIMA), Eneso and Vector Pipe involves designing an innovative portable system that is capable of improving the early diagnosis of REM Sleep Behaviour Disorder (RBD), which is closely linked to neurodegenerative diseases, such as Parkinson's disease.

Miniaturised technology developed by TECNALIA

TECNALIA has developed mACQ, a miniaturised module to record signals, such as EEG and EMG, within the framework of the project, based on theCLASS technological asset.

This device enables:

• Up to eight physiological signal channels to be registered.
• Information to be transmitted to the SMOTTS system HUB in real time via Bluetooth Low Energy .
• Electrodes specifically designed to minimise discomfort during the night to be integrated.

Furthermore, due to its versatile architecture, mACQ can be adapted to other medical applications (EMG, EEG, ECG...), significantly extending its market transfer potential. The SMOTTS system is currently being tested in a clinical trial with 20 Sleep Unit patients at Malaga Civil Hospital. The aim of this study is to compare the efficacy of SMOTTS in the diagnosis of REM RBD versus standard clinical practice by means of overnight polysomnography.

A system with clinical intelligence

SMOTTS will integrate all its components in an IoMT (Internet of Medical Things) architecture with fault tolerance and advanced alarm management.

The system will be able to:

• Detect abnormal events during sleep.
• Provide the specialist with reliable clinical criteria for diagnosis.

This approach is based on TECNALIA’s experience spanning more than 15 years, extensive knowledge in Neural Interfaces and clinical collaborations, such as that of the Neurosciences Unit at Malaga Regional University Hospital.

Health, social and industrial impact

The development of SMOTTS has a dual impact:

1. On the health system

• It reduces costs by facilitating outpatient diagnostics.
• It delays or mitigates the progression of neurodegenerative diseases through early intervention.
• It improves equity and universality of access to sleep studies.
• It can benefit 900,000 people in Spain over the age of 55 who may suffer from REM RBD or associated disorders.

2. On the industrial sector

• It generates new opportunities for companies with expertise in medical devices.
• It opens the door to a competitor-free exportable product, integrating the proposed functionalities.
• It promotes the development of health technologies based on science and innovation.