When Apple announced its Series 6 Watch wearable last month, with new features, including VO2 Max and blood oxygenation sensors, the tech giant also announced three new clinical studies that would use the device.
We expounded on one, an asthma study, in collaboration with Anthem, last month. But the other two, focused on heart failure and respiratory conditions like flu, respectively, have not been covered in detail by the press. We had the opportunity to chat with Apple Health VP Dr. Sumbul Desai to learn more about these other two investigations.
“We want to be responsible and do right by the user. Everything that we focus on in Health at Apple is grounded in science,” Desai said. “We're working with researchers, helping them understand how to use our sensors in certain clinical scenarios.”
Both studies are small compared to undertakings like the Apple Heart Study, starting with cohorts of around 1,000 but with the possibility to expand as the studies go on.
Using new signals to study heart failure
For the heart failure study, Apple has teamed up with a research team out of the University of Toronto led by Dr. Heather Ross. In an invitation-only study of patients with heart failure, researchers will use Apple Watch sensors, including the new VO2 Max algorithm, along with traditional in-clinic assessments, to monitor patients through the course of their treatment.
The goal of the study will be to see how much meaningful assessment of the patients can be accomplished with the signals from the Watch.
“We’re working with the team at UHN to help understand which interventions are having the most impact on the physiological signals” Desai said. “This study is about measuring the cardiovascular and pulmonary signals that are important, but also how does it potentially change how you manage heart failure from a clinical management standpoint?”
Cardiorespiratory fitness, as measured by VO2 Max, is emerging as an increasingly important indicator of overall health. The Apple Watch is not the first device to measure VO2 Max, but it is the first to measure the full range of VO2 Max. Other wearables have focused on the high ranges, which are useful for athletes but less useful for the general public.
At the University Health Network, where the study will be conducted, clinicians already use VO2 Max as an assessment, but they can currently only measure it in-clinic with an involved in-person test, so the Watch will allow for more frequent monitoring.
Supplementing the Seattle Flu Study
Apple’s work with the Seattle Flu Study and the University of Washington is along the same lines – participants will be monitored with the Watch, as well as with traditional respiratory panel tests (delivered via home testing), so researchers can start to understand how much power the Watch’s blood oxygenation sensor, for example, has to predict respiratory infections.
“The hope is that physiological signals from the Apple Watch will make it possible to identify people who are falling ill, and get them tested quickly so they can self-isolate and break the chain of transmission of the virus in the community,” Dr. Jay Shendure, professor of genome sciences at the University of Washington School of Medicine, said in a statement.
The study tests groups of patients in Seattle to look for early indicators of respiratory diseases, including both flu and COVID-19. The group includes high-risk individuals like frontline workers, and it's also being selected with an eye toward representative inclusion.
“We will work closely with our community partners to recruit from Latinx, Black and Native American communities, who are often underrepresented in research, but are disproportionately affected by this pandemic,” co-principal investigator Helen Y. Chu said in a statement.
According to a release from the University of Washington, the study will also utilize Apple’s handwashing-reminder function to help reduce the likelihood of viral infections.
Sensors still for health and wellness
Although Apple is collaborating with researchers to put them to use in clinical settings, Desai stressed that the sensors in its devices are for health and wellness purposes, and that users shouldn’t rely on the device for clinical information.
But the learnings from these studies could feed into future product development or labeling – just as the Apple Heart Study helped the company to develop its FDA-cleared heart rhythm algorithms.