By Pragati Verma, Contributor
You can call them virtual clinical trials.
Researchers at Boston Children’s Hospital (BCH) are conducting a research trial along with Vanderbilt University Medical Center to find out if an anesthetic called Ketamine can help patients of Rett syndrome—a rare neurological disorder that primarily afflicts girls’ ability to speak, walk, eat, and even breathe.
However, it’s not a typical clinical trial where researchers and clinicians assess the safety and effectiveness of the new treatment intermittently, with patients visiting the medical center each time. Instead, patients enrolled in BCH trials wear sensor-embedded, machine-washable shirts that enable researchers and clinicians to remotely monitor their breathing, heart rate, and hand movement. This means patients can stay in the comfort of their own homes, while still participating in the study.
Smart sensor-embedded clothes are a very patient-friendly way of providing a continuous stream of data to researchers, says Pierre-Alexandre Fournier, co-founder and CEO Hexoskin, a Montreal-based startup that designed the smart shirts used in the study. “It’s much easier to recruit patients if they don’t have to visit clinics too often or wear heavy, clunky devices for several days,” he explains.
Gartner researchers agree with Fournier and predict smart clothing to be one of the fastest growing areas of the wearable devices market. “These discrete and nearly invisible wearables will particularly increase acceptance among reluctant end users,” says Alan Antin, senior research director at Gartner. The technology research firm expects a tenth of all wearables to be unobtrusive to wearers by 2023.
According to Fournier, hundreds of researchers are already using their smart shirts to reduce the travel frequency of patients and study participants. Participants simply wear the machine washable smart shirts that come with built-in clinical grade textile electrocardiogram and respiratory sensors. The data collected by sensors is stored in a tiny, rectangular device that discreetly sits in their shirt’s zippered pockets. Researchers and clinicians can remotely monitor and analyze this data in real time on Hexoskin’s Connected Health platform and patients only need to travel to the health center to get their dose of the medicine being tested.
“Clothing is the visible part and has to be great for people to wear it long term… What matters most is having the best technologies and tools to collect and analyze the most relevant data continuously.”
—Pierre-Alexandre Fournier, co-founder and CEO, Hexoskin
While Fournier is excited about non-invasive sensors making clinical trials patient-friendly, he is clear that the ability to provide more precise, rich, and continuous real-time stream of data is the true game changer. “Medicine’s progress depends on being able to better observe patient outcomes,” he says. “Clothing is the visible part and has to be great for people to wear it long term, but it’s really about the data in the end. What matters most is having the best technologies and tools to collect and analyze the most relevant data continuously.”
He has a point. Hexoskin’s smart clothing and platform have been used to collect data for more than 80 scientific publications across specialties, including cardiology and physiological psychology, as well as sleep patterns and aging, among others.
And researchers across the world are exploring how smart clothes, embedded with medical-grade sensors, can transform a centuries-old system for collecting the data needed to diagnose and manage a disease. Take Canadian Institutes of Health Research, for instance. It has launched a five-year program to gather biological and vital signs data through Hexoskin’s smart clothing and health-monitoring solution to help people living with myalgic encephalomyelitis (ME), also known as chronic fatigue symptom. “This project will build the largest long-term cardiopulmonary and activity database in the world for patients with ME,” Fournier says.
From Fitness to Health
Founded in 2006, Hexoskin was one of the first companies to make smart shirts that capture cardiac, respiratory, and activity body metrics. “We were initially planning to develop sensors and information systems to support artificial intelligence applications for problems related to aging and chronic diseases clinical research and healthcare,” recalls Fournier.
In addition to monitoring astronauts inside the International Space Station, smart shirts are now being used by professional athletes, trainers and health professionals around the world.
However, they were too early to the market, he says, as there was no infrastructure to collect data that healthcare companies would use. So, they decided to target elite sports, defense, and aerospace industries. “We worked with the Canadian Space Agency and NASA, where we monitored astronauts inside the International Space Station,” he says. In addition to astronauts, their “smart shirts are now being used by NBA players, Cirque du Soleil, and thousands of athletes, trainers, and health professionals all over the world,” he says.
In fact, most other smart clothing sellers remain focused on athletes and fitness enthusiasts, monitoring and improving sports performance, providing insights on intensity and recovery, fatigue level, calories burned, and sleep quality. Athos, for instance, integrates electromyography, a clinical technology that captures what muscles are doing, into its clothing to measure and improve athletes’ performance. Ambiotex shirts use electrocardiogram sensors to capture athletes’ vital parameters and activities and provide training recommendations, such as warn the wearer if a certain exercise is too hard for them or if their stress level is too high during a session.
As these smart clothes lay chips and sensors—currently embedded in smart watches on wrists—all over the body, companies like Hexoskin are betting on making inroads into healthcare. Smartwatches made the transition, Fournier argues: While researchers at Brigham and Women’s Hospital in Boston are using Apple watches to examine physical activity and heart data to identify early warning signs of declining heart health, Kaiser Permanente is remotely examining cardiac patients’ daily heart rates and activities with Samsung watches.
Doctor in Your Shirt
That’s exactly what Fournier plans to accomplish with smart shirts. His vision is to move beyond trials and enable physicians to recommend their smart shirts for vital signs monitoring of patients with chronic conditions. “We are going through the FDA process in the United States now and expect clearance for our new shirts by the end of the year. That’s when physicians will be able to prescribe our smart shirts in a way that insurance companies will reimburse patients,” he says.
“Smart clothes will help early discharge of patients, keep them home, and even prevent hospital admissions for patients with chronic cardiac or chronic respiratory diseases.” Hexoskin is already working with Mayo Clinic to explore how their sensor-laden clothes connected to a remote patient monitoring platform can help in-home patient rehabilitation.
When healthcare companies like Mayo will start prescribing smart clothes, they will open new possibilities for real-time monitoring of patients with chronic conditions. And, as Fournier says, “You will have millions of people wear them to get access to better care and better ways of managing their health.”