Stephanie Misono, MD, MPH, had never worked with medical devices before — but her idea to repurpose one for her patients opened new doors in her research.
Dr. Misono treats patients who suffer from chronic cough, defined as a cough that lasts longer than eight weeks despite treatment of potentially contributing factors. It’s a debilitating condition that often prevents patients from doing normal things, such as attending meetings at work, going to church, and holding long conversations.
Although sometimes a clear cause can be found for the cough, such as asthma or reflux, often the cough can persist even when common causes are ruled out or addressed. Scientists estimate that unexplained chronic cough affects up to 1 in 20 adults worldwide.
For years, she had wondered if a device that delivers vibrations to the throat could bring relief to her patients and millions of others worldwide. But until she stumbled across a pilot grant opportunity, the timing never felt quite right to pursue the idea. “I saw this grant opportunity from CTSI and thought, ‘This is the ideal grant for this scenario — I should go for it,’” Dr. Misono recalls.
Dr. Misono received comprehensive early support from the Clinical and Translational Science Institute (CTSI) during the protocol development process, which helped pave the way for a successful pilot study. She has since gone on to publish promising results in Laryngoscope and secure an R34 grant from the NIH to bring this potentially life-changing innovation to patients.
From idea to breakthrough
An associate professor in the Department of Otolaryngology-Head & Neck Surgery, Dr. Misono built her early career focusing on disorders like voice and airway problems and throat cancer.
Venturing into research involving a medical device was unfamiliar territory, but the Clinical Research Support Center (CRSC) helped her navigate the challenges. CTSI is one of the many collaborators behind the CRSC, which brings together clinical research experts to help University researchers navigate the complex clinical research environment and set up their studies for success.
“Being able to tap into the CRSC is what made the research possible,” she said. “If I were trying to do it on my own, it would have taken so much time and energy that it would’ve been difficult to get the study off the ground.”
Through the CRSC, Dr. Misono’s proposal underwent a feasibility review to prepare it for submission to the Institutional Review Board (IRB) and other regulatory requirements.
Feasibility reviews are a quick, free way for University researchers to refine a protocol for FDA or IRB submission and set it up for successful implementation. In just one meeting, clinical research experts thoroughly review a researcher’s protocol and study materials, identify potential logistical and compliance challenges, and offer resolutions for overcoming them.
“They identified things that needed to be clarified or further developed before submitting,” Dr. Misono says. “A feasibility review set my project up for success — it was much faster than it would have been otherwise.”
Available to all faculty, feasibility reviews are completed in one week. It’s one of the many free services available through the CRSC.
“It was very efficient and professional. Also, it is so helpful to feel supported through a complex process like this,” Dr. Misono says. “I appreciate that there is the chance to ask follow-up questions and continue the conversation beyond the formal review session.”
How to stop the feedback loop
The idea for the device came from what Dr. Misono was hearing from her patients.
“I was thinking about the fact that a lot of my patients will say, ‘I get this kind of itch or tickle sensation, and it makes me feel like I have to cough because otherwise that feeling is never going to go away, and it's uncomfortable and frustrating,’” she says. “It’s really a vicious cycle. So, the idea was to use vibration to introduce a different sensory input to the larynx that could maybe change that feedback loop.”
It works like this: a stimulus triggers a cough, which increases the throat’s sensitivity. Over time, this heightened sensitivity means that even minor irritants, like strong smells or temperature changes, can lead to intense coughing fits.
Dr. Misono hypothesized that introducing vibrations to the throat could disrupt that cycle and prevent it from recurring.
A device with potential
To test her theory, Dr. Misono turned to a small laryngeal vibrating device developed by Juergen Konczak, a professor in the University’s Department of Kinesiology. Dr. Konczak created the device to treat a different disorder (laryngeal dystonia) with translational research funding from CTSI, but it fit seamlessly into Dr. Misono’s study.
Participants used the device for two weeks, with almost everyone reporting that it was simple and comfortable to use. More importantly, the device, which is applied to the outside of the throat, significantly reduced cough severity for most participants. A few participants were reluctant to return the device at the end of their participation, in case their coughs flared up again.
The results were enough to encourage Dr. Misono to apply for the NIH grant. The funding from that grant will allow her to prepare for a larger clinical trial.
A broad portfolio of resources
Dr. Misono’s decision to tap into CTSI resources was a logical step. Since joining the University of Minnesota faculty in 2011, she’s regularly used the institute’s resources.
Early in her career, she received a Pre-K grant (now called the K Accelerator Program) that helped spur her research trajectory.
“At the time, I was trying to start a new line of research as a brand new faculty member, and didn't know very many people here yet. I knew the question I wanted to look at was interesting for my field, but to make an impact and get funded, I needed to engage people outside my area,” she said. “The program helped me find a community of people with whom I could share ideas and strategies. That was really important for refining my ideas and giving them traction.”
Dr. Misono was also among the inaugural cohort of a yearlong CTSI program aimed at supporting research-intensive health sciences faculty who are raising young children, now called Parents Leading Science.
In addition, she has participated in two other CTSI offerings: the K12 Scholars Career Development Program (previously called KL2) and the K-R01 Transition to Independence Program, both of which provide funding and mentorship for researchers. These programs helped pave the way for her future grant success, as she notes:
“CTSI's career development programs had a major impact on my research career. The incredible ecosystem of support around me was vital to securing my NIH K23."
Today, she serves as a mentor to an early-career researcher in that same K12 program.
“There’s such a broad portfolio of different resources and educational opportunities in CTSI,” Dr. Misono said. “The richness of the portfolio allows people to connect with an appropriate type or level of resource at any career stage, and makes challenging things possible. I am deeply grateful to CTSI for the wonderful community and opportunities it offers.”
“Being able to tap into the CRSC is what made the research possible. If I were trying to do it on my own, it would have taken so much time and energy that it would’ve been difficult to get the study off the ground.”
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