NuvoAir Participates in ALS Home-Based Study
In 2018, NuvoAir had the privilege to be apart of conducting a study on ALS (Amyotrophic Lateral Sclerosis) in the United States. The study was conducted by researchers at Barrow Neurological Institute and Beth Israel Hospital, a teaching hospital of Harvard Medical School.
One hundred and eleven ALS patients were enrolled in the study while 30 healthy individuals also participated. The participants were spread out across 41 states and consisted of 74 men and 62 women. The objective of the study was to design a clinical ALS study where patients were remotely recruited, screened and enrolled. They were then instructed to collect daily data at home by themselves or by caregivers for assessment.
Participants were provided with the following self-care equipment: our NuvoAir spirometer, the Camry Handgrip Dynamometer, the ALS at home Speech App, the Skulpt Scanner- an electrical impedance myography device, and Actigraph - an activity tracker. Upon receiving the devices, the participants were instructed to learn how to use them via a series of online videos. Subsequently, the subjects collected data on a daily basis for three months and twice a week for the following six months. The study found that 72% of ALS patients and 88% of healthy subjects who were sent the equipment were able to complete the initial set of measurements.
Our NuvoAir spirometer collected and stored respiratory data including FVC and FEV1 in our compliant health cloud after the measurements were obtained. Our technology was selected to be utilized in this study given the simplicity of use in a home setting and due to the fact respiratory complications are the main cause of death for ALS patients. This research suggests that stronger proactive management of the lungs could enhance research and have a significant impact on survival.
A standard approach to clinical trial design in ALS has transpired throughout several decades. In 2017, four researchers in France published a paper titled “Are we any closer to registering a new treatment?” outlining the difficulties associated with today’s standard clinical trial method. As stated in their paper, regardless of the prolonged knowledge of ALS, several flaws in the way studies are conducted remain evident. They believe that despite that even though the condition was first characterized a century and a half back, the extensive accumulated scientific knowledge has yet to be sufficient for the development of effective therapeutic strategies.
To date, the majority of patients are sent to medical centers to be studied and screened in-person. Due to the need for frequent visits for evaluation, this limits the number of potential trial participants if they are not within close proximity. Travel may be manageable at the early stage of diagnosis, but as the disease progresses it often becomes difficult for the patient which results in a decline in participant retention.
Research currently shows that ALS patients progress at very different rates, indicating that some patients decline at a slow rate while others extremely rapidly. Together these two factors mean that late-stage trials typically require hundreds of patients per group. The number of participants not only need to exceed the hundreds but these individuals need to be studied for at least six months or more to have adequate data to identify the effectiveness of the treatment.
In conclusion, the ALS longitudinal studies with frequent data collection at home that we participated in outlines the possibility to design and institute home-based ALS studies. Through various internet-connected measurement devices and web-based training, the study was effective in collecting data that otherwise have been difficult to obtain in large quantities of participants.