One student’s ambition leads Carnegie Mellon to sponsor first ever clinical trial
After four years, Erica Martelly’s dream of testing custom CPAP masks on real patients came to fruition in Carnegie Mellon University’s first ever clinical trial.
If engineers followed the age-old adage “If it ain’t broke, don’t fix it,” we wouldn’t have 95% of the technology that we can’t imagine our lives without. So when Erica Martelly was tasked with hosting a clinical trial—something CMU has never done before—she didn’t bat an eye.
Martelly, a Ph.D. student in mechanical engineering, joined Kenji Shimada’s lab in 2018 to advance research on an existing project focused on developing comfortable, customizable sleep apnea masks. Shimada, a professor of mechanical engineering, and his team were developing a user-friendly software capable of generating custom mask designs via photogrammetry that could then be easily 3D printed.
“Our goal was to make something more comfortable than what is currently on the market, in a way that was simple enough for a technician to use without extensive training,” said Martelly.
Once the software was running, the team needed to conduct a clinical trial to test the efficiency and comfortability of the masks. But without a CMU medical school, Martelly couldn’t lean on existing processes.
Participant is fitting with a face mask.
“We collaborated with Allegheny General Hospital and the Allegheny Health Network, but because we don’t have a medical school, the trial was sponsored by the university. We needed to obtain insurance and create a legal clinical trial agreement between the university and the hospital.”
After nearly four years of back and forth between the Institutional Review Board, the Food and Drug Administration, the hospital, and the university, the first patient was enrolled in the study during the fall of 2023.
Phogrammetry setup to measure participant faces for custom masks
Participants in the trial wore custom masks printed by Shimada’s lab in a sleep study so that researchers could analyze patients’ oxygen saturation levels, eye movement, brain activity, and more.
Despite success in the trials, Martelly said, “The coolest thing I’m taking away from this project is not the mask itself but that we got a clinical trial off the ground. I don’t think researchers knew it was a possibility, but because we were pioneers, I’m confident other projects can move forward in their own clinical trials without partnering with a medical school.”
If you’re looking to take a new path, whether that be a clinical trial or not, my advice would be to ask for help. Use your network and use the CMU community to your advantage.
Erica Martelly, Ph.D. student, Mechanical Engineering
“If you’re looking to take a new path, whether that be a clinical trial or not,” she continued, “my advice would be to ask for help. Use your network and use the CMU community to your advantage.”
Pictured, top: Erica Martelly presents on the mask assembly process.