27 April 2022
The Pneumonology Department of the Hospital Universitari Dr. Josep Trueta in Girona has given the go-ahead to INNOBICS-SAHS, a new European project that aims to improve the diagnosis and treatment of obstructive sleep apnea in primary care centres. The project will have a duration of 3 years and resulted from the concerns of the pneumonology team of the Trueta Hospital in Girona and the Santa Caterina Hospital in Salt, in addition to many years of research and leading clinical practice focused on this disease at the Girona hospital and at various primary care centres of the Catalan Health Institute (ICS) and the Institute of Healthcare (IAS) belonging to the Girona Healthcare Region.
“Sleep apnea is a major public health concern that affects one in four people and can lead to serious cardiovascular problems, neurocognitive impairment, and even occupational and traffic accidents if it is not properly diagnosed and treated”, explains Dr. Anton Obrador, coordinator of the project and emeritus pneumologist at the Sleep Unit of the Hospital Trueta in Girona.
The project has a budget of 3.1 million euros, and is funded by EIT Health together with other participating entities: the Catalan Health Institute of Girona, the Institute for Biomedical Research of Girona Dr. Josep Trueta (IDIBGI), the TIC Salut Social Foundation, the Centro Hospitalar Lisboa Norte, Pulso Ediciones, TRC Informatica, the Interuniversity Microelectronics Centre, ResMed Spain and Oxigen Salud. The selection process to obtain funding for the project was highly competitive, with 164 European projects submitted, of which 33 made it to the final phase and with only 13 being awarded.
Obstructive sleep apnea is a disorder that causes airway obstruction during sleep due to relaxation of the muscles at the back of the throat. People who suffer from it tend to wake up several times during the night with a difficulty in breathing, although they are often unaware of it because they fall back to sleep almost immediately. Other symptoms are snoring and wheezing during sleep, and excessive daytime somnolence, which is one of the common causes of traffic and occupational accidents. The variability of symptoms, the failure to identify the disease and the difficulty faced by hospitals in responding to all the demand means that diagnosis is much lower than the number of real cases.
Sleep apnea syndrome is a very widespread disease that mainly affects men between 30 and 60 years of age, and which increases with age and body mass index. It is an underdiagnosed condition. According to research, only 10% of cases are currently diagnosed in specialised hospital units in Spain, which usually have waiting lists of more than one year. The aim of INNOBICS-SAHS is to improve the diagnosis of the disease by 300%. As Dr. Obrador explains, “we want to act faster, reduce waiting times and make it easier for patients to be diagnosed and treated at their nearest primary care centre”. To this end, the Virtual Unit will be set up in the Hospital’s Sleep Unit and primary care will be provided both in terms of human and technical resources.
The first step will be to develop a short questionnaire lasting no more than a minute so that primary care medical or nursery professionals can assess patients with suspected sleep apnea. After this first screening, if the results are positive, the patient will be referred to a new member of the primary care staff: the sleep apnea nurse.
Once the patient is seen by the primary care centre’s sleep nurse, they will be given an electromedical device (sleep polygraph) which they will take home to monitor their heart rate and vital signs over the course of a night. Until now, this device was only provided by hospital units specialising in sleep.
In order to carry out the project, more than 60 nursery professionals will undergo training, and two virtual units will be created, one in Girona and one in Lisbon, with all the data obtained from the devices being uploaded so that the professionals can interact and make virtual diagnoses and propose treatment.
The public administration will ensure the correct introduction and use of technology in the healthcare process at all times, explained Jesús Berdún, head of the project at the TIC Salut Social Foundation of the Generalitat de Catalunya: “it will facilitate the digital transformation of the diagnostic process by means of data integration and the creation of a virtual support unit. This will provide primary care centres with the necessary tools to improve the healthcare process, thus directly benefiting patients”.
Those at the forefront of the project assure that the implementation of this new diagnostic procedure will reduce the waiting time for patients who are referred to the specialised sleep units of hospitals down to 30 days. In Catalonia, the diagnostic process will be tested in select primary care centres, and three years into the project, a proposal will be drawn up to implement it in more Catalan primary care centres and to export it to other autonomous communities and across Europe. On an international level, the support of EIT Health, a network of more than 150 partners with the support of the European Institute of Innovation and Technology, which is a European Union body, is key to this project. As such, the INNOBICS project will have extensive access to the knowledge and expertise of all these European partners.
At present, there are already four basic health areas (ABS) that have started diagnosing sleep apnea using this methodology: Salt, Sarrià, Celrà and Dr. Joan Vilaplana – Girona. From May it will be introduced in Sils, Santa Coloma de Farners and Anglès. From June in Cassà de la Selva, Arbúcies, Sant Hilari and Breda-Hostalric. And between October and November, it will be implemented in the rest of the basic health areas (ABS) of the city of Girona as well as in Banyoles. This will result in the full implementation of this methodology in all the ABSs under the Trueta and Santa Caterina hospitals, paving the way for its implementation throughout the rest of the region.
The project arose in 2014 out of the concerns of Dr. Ramon Orriols, head of the Pneumonology Service of the two centres, and his medical team, who regarded the underdiagnosis of sleep apnea as “a medical problem of the highest magnitude”. Thus, the team of pneumonologists began working with the basic health areas (ABSs) under the canopy of the two hospitals in order to start diagnosing sleep apnea from the primary care level.
From 2014 to 2016 a pilot trial was carried out, led by Dr. Èric Rojas, a pneumonologist from the Sleep Unit of the Trueta and Santa Caterina Hospitals. The premise of this project was that 80% of people at some point in their lives are treated at a primary care centre. Moreover, the main users of these resources – patients with a high prevalence of diabetes, high blood pressure and obesity – are also the ones who are most likely to suffer from sleep apnea. Therefore, it was deemed that primary care centres are the ideal setting in which to diagnose this pathology.
The study involved comparing the automatic diagnosis of obstructive sleep apnea obtained by means of nocturnal home pulse oximetry and home respiratory polygraphy, which was then assessed by the corresponding primary care doctors, with the manual diagnosis of the respiratory polygraphy and the full polygraphy procedures carried out by the pneumonologist within the hospital setting.
The study focused on two ABSs that have Trueta as a referral hospital (Sarrià de Ter and Santa Clara) and two ABSs that have the Hospital de Santa Caterina as a referral centre (Sils and Salt). A total of 599 patients were randomly selected, of which 97 finally participated in the study. 61% of these patients were men, with an average age of 57, all with class 1 obesity and most of them ex-smokers.
The results of the pilot study showed that 98.8% of the polygraph results obtained automatically coincided with those obtained manually by the pneumonologists, demonstrating a positive diagnosis of obstructive sleep apnea. With regard to severity, there was a coincidence in 95% of the cases in which the primary care physician indicated that the case was serious.
The findings of the study indicate that obstructive sleep apnea can be diagnosed in the primary care setting and that automatic analysis allows for the diagnosis of obstructive apnea, especially when it is severe. These results have been shared in several national and international congresses and the positive reception of the project has encouraged the researchers involved to submit it to EIT Health.
The main risk factor for obstructive sleep apnea is obesity. In the mildest cases, medical professionals usually recommend changes to lifestyle, such as eating a more balanced diet and exercising in order to lose weight, or giving up smoking. In more moderate or severe cases, patients must use – usually on a temporary basis, although in some cases indefinitely – a continuous positive airway pressure device when they sleep. Exceptionally, only a minority of patients will require other methods or perhaps surgery to prevent airway obstruction.
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