Harald Hrubos-Strøm, PhD, Akerhus University Hospital, Oslo, Norway, introduces us to the SLEEP REVOLUTION project – a large, multicenter grant project financed by Horizon 2020. The project’s primary aim is to facilitate the modernization of diagnosis and treatment of obstructive sleep apnoea (OSA) by integrating personalized health care based on digital diagnostics and therapeutics with health data integration. Approximately 25% of OSA patients do not tolerate CPAP therapy, driving research towards improved disease phenotyping to characterize responders and identify novel pharmaceutical and non-pharmaceutical therapies. An alternative to CPAP therapy is focused training of the orofacial muscles, which leads to increased tongue, pharynx, and soft palate muscle tone. There is some evidence that exercises of the stomatognathic system may be effective in OSA treatment. Dr. Hrubos-Strøm is currently focusing on the development of a patient-centric digital platform to improve compliance for orofacial myofunctional training interventions with autofeedback from visualized summaries of self-report as an alternative to continuous positive airway pressure (CPAP) treatment for OSA. This interview took place during the World Sleep Congress 2022 in Rome, Italy.
Transcript (edited for clarity)
The Sleep Revolution Project is a large multicenter project that was financed by the Horizon 2020. We got funding from the beginning of 2021. So, the project started in March 2021, and it has a diagnostic part, and it has a treatment part. So, I’m mostly involved in the treatment part, Work Package Leader of Work Package 9, and we are going to look at the effect of myofunctional therapy in patients with OSA...
The Sleep Revolution Project is a large multicenter project that was financed by the Horizon 2020. We got funding from the beginning of 2021. So, the project started in March 2021, and it has a diagnostic part, and it has a treatment part. So, I’m mostly involved in the treatment part, Work Package Leader of Work Package 9, and we are going to look at the effect of myofunctional therapy in patients with OSA.
Myofunctional therapy is a focused lifestyle intervention that will help patients with OSA to strengthen up the muscles in the tongue and the pharynx, and it has been quite promising with pilot studies, so initial randomized control trials published for the last 10 years, but still, the evidence is lacking in order to start treatment on a regular basis in normal patients.
As in all other types of treatment, you need some effort to do this treatment, so we have reviewed the literature, and we have identified eight exercises that will take approximately 30 minutes per day to do. So, we have three sessions, one for 10 minutes and we have also slightly different content for the midday exercise because some of the exercises include putting a finger in the mouth with a glove. You can’t do that because of social nonacceptance for that in particular, in COVID times. So, the midday exercises are slightly less time consuming, but it will be approximately 30 minutes per day for three months.
One of the problems that all the previous studies have been therapeutic-led studies, and they have excluded patients that are nonadherent, so they had not chosen a treatment design. They have chosen a per-protocol design, excluding nonadherent subjects, so we’re really working with the Sleep Revolution Digital Platform to motivate and to help people to do the exercises. So we will have instruction videos. We will have reminders, and we will also have something we call auto-feedback, and that means that you get feedback on the exercises you do and also on the effect that you do.
So, the project is for four years, and the first year we have mostly reviewed the literature, and we have started on the first pilot, but it takes a lot of time to get ethical approval and all the technical platforms up and running. So, we will proceed then with the data collection, the first pilot now, and then we’ll have in-depth use, and then we will have a second pilot testing all the digital systems. And then finally, we will include 100 subjects with mild to moderate sleep apnea from the end of next year, hopefully. So, in the symposium on Tuesday morning, the most interesting part is that we have participants in the symposium with focus on medication therapy on sleep apnea, and more general exercises, not focused like my functional therapy and also Winfried Randerath will give a presentation on the 3D model and the overall concept of non-CPAP treatment for sleep apnea because we know that’s approximately 25% of sleep apnea patients do not tolerate CPAP.
So, it’s really a large need for non-CPAP therapies, but we really need to find out how to phenotype these patients, and we need alternatives. And I think for the patients motivated to do focus training but not necessarily motivated to go out running or doing more general exercise, this kind of treatment will be optimal. And we want to include newly diagnosed patients because we think that if you already have experienced CPAP failure, you are less motivated to start with this treatment, so we will include newly diagnosed patients in this study. So I think when we have reviewed the literature we identified some limitations in the previous studies, as I said. Intention to treat has not been followed as a principle in the previous studies, and also it is a problem with long term follow-up. We will have our outcome assessment after three months, but we will have a open-label, follow-up study if we can get funding for that, also in our study.
The final thing we lack in previous studies is blinded outcome assessment. So that means that the same therapist has evaluated the outcome as the one treating patients. So we will change that by doing a separate evaluation by one researcher and then delivering the treatment by another researcher, so then we can have a more blinded design than previous studies. So of course, we hope that this study, this large study is twice as big as the second biggest study, will show effect but we are curious about that.
I think the most crucial thing to clarify before we start including patients, is how to phenotype the participants because as soon as we include, we will follow them through the whole three month period. But we really think that not all sleep apnea patients will have benefits from this kind of treatment. So, obviously, if patients are motivated, that will be the most essential phenotype, but of course, we also think that people need to be able to breathe through their nose. We think that if there were mouth breathers, it will be hard to do these exercises if it’s a mechanical stop in the nose. And we also consider to use cephalometry or PSG based endotyping, but we haven’t concluded on that yet.