The aim of the feasibility study, which started in July this year, is to gather information on a variety of potential digital measures captured with different devices and their ability of reflecting sleep disturbances or fatigue. Apart from comparing data between different measures from patients with neurodegenerative disorders or immune-mediated inflammatory diseases as well as healthy participants, we also want to know, which devices participants find easy or enjoyable to use and are as unobtrusive as possible. This is essential for the larger clinical validation study planned to start in 2022, which will use the most promising subset of the tested digital measures, to make sure participants are able and willing to use the devices on a daily basis.
As Covid-19 has been impacting the preparations, the least affected site, Kiel in Germany, was the first to start recruiting participants in July 2020. By now, three of our four sites are recruiting and we hope to start recruitment at the last site shortly. Janet van Uem is a medical doctor coordinating the local recruitment of healthy volunteers and Parkinson’s disease patients in Kiel. She says that the work so far has been both challenging and rewarding.
“For me, it was really interesting to get to know the different devices and the digital measures that can be derived from them. Getting continuous health measures from people in their normal surrounding, will help to give us new insights on their diseases and the impact of fatigue and sleep disturbances on their everyday life.”
Dr. Janet van Uem
With the help of the multidisciplinary IDEA-FAST team spread across Europe, the sites were able to overcome initial technical and logistical challenges during the setup phase of the study.
“Before giving the devices to our participants, we tried them out in our clinical team. This was a very important step not only to be able to relate to our participants later but also to improve the device setup and support process in collaboration with our colleagues from Newcastle”
Dr. van Uem reports. She was pleasantly surprised by the dedication most participants showed.
“The vast majority of our participants is very interested to see what these devices can do and take great care in making sure they are using the devices correctly. Because we are asking our participants to try out many different devices over the course of four weeks, I was a little worried that their motivation might drop at some point. However, we get the feedback that participants are happy to be involved in this research project and enjoy the weekly interactions with our study team. Moreover, our participants are interested in understanding the collected (sleep and fatigue) data themselves.”
From our participants we get the feedback that they enjoy the close interaction with our clinical team and the technology:
“I really liked interacting with my contact person and getting to know the technology throughout the four weeks. I found it very convenient that I only had to come to the hospital once”
“I am always interested in exploring new technology and am excited that I could contribute to this international study. Looking at the reports I saw from different devices was very interesting especially for the sleep measures. I feel like there were some devices that captured my waking phases during sleep better than others. In general, I can say that the deep sleep phases reported by the devices match with the previous knowledge of my sleep pattern.”
Using device data, qualitative interviews and participant questionnaires, the analysis team will determine the most reliable measures from the digital parameters tested.
Thereby, the feasibility study, which will continue until March 2021, will help us to select the best digital measures to evaluate sleep disturbances and fatigue. The long-term goal of IDEA-FAST is to make sure objective measures of sleep disturbances and fatigue, collected in the environment where people live, can be included in future clinical trials. By collecting information on these disabling symptoms, the effect of treatment on sleep disturbances and fatigue can be determined.