Contact: Theresa Shumard
Sleep Apnea Patients Seek to Inform and Accelerate Medical Product Development
June 8 meeting will highlight unmet medical needs & treatment expectations from patient point-of-view
Washington, D.C. – May 29, 2018 – People from across the U.S. who are living with sleep apnea will gather in College Park, Maryland, on June 8, 2018 to share what it’s like to live with sleep apnea with FDA regulators, drug and medical device developers, and researchers. This meeting is part of a series started by FDA in 2013 to inform regulatory decision-making. It will feature discussions on the path to diagnosis, impacts on daily living, symptom management, and treatment expectations and adherence.
Hosted by the American Sleep Apnea Association (ASAA), the June 8 meeting caps the AWAKE Sleep Apnea initiative, an education and empowerment initiative launched in April. Participants on-site and viewing via a live webcast will have the opportunity to offer their perspectives through live polling questions and moderated discussion. Dialogue at the meeting will be shaped by interim results of an online Patient & Caregiver survey that has already attracted more than 2,220 responses and remains open for additional responses through June 29, 2018.
Nearly 18 million Americans of all ages have sleep apnea, a disorder that causes people to stop breathing during sleep, sometimes hundreds of times each night. Survey respondents reported high rates of severe to moderate fatigue (80%), daytime sleepiness (77%), and cognitive problems (49%), even among those who faithfully use continuous positive airway pressure devices at night, a centerpiece of sleep apnea treatment. Sleep apnea can have severe health consequences and is linked to increased rates of other serious conditions. In fact, 56% of survey respondents reported having high blood pressure; 28% indicated they have diabetes, and 25% have depression or another mood disorder. Sixty-two percent (62%) expressed that their greatest concern about living with sleep apnea is its long-term impact on their health and lifespan.
Patient panelists include women and men from Los Angeles, Brooklyn, Las Vegas, Colorado Springs, Virginia Beach, Key Biscayne, Portland, Maine, and San Juan, Texas. ASAA’s chief patient officer Adam Amdur will make introductory remarks and board-certified sleep specialist Dr. Shelley Berson will provide an overview of diagnosis and treatment. To close the day, FDA’s Kathryn O’Callaghan, associate director for strategic programs at the Center for Devices and Radiological Health, will summarize the input received from patients and will describe how FDA uses such information in the assessment of benefits and risks, evaluating clinical trial designs, and safety surveillance. View the meeting agenda here.
A full report on patient perspectives shared at the AWAKE Sleep Apnea Patient-Focused Medical Product Development meeting, including through the live polling questions and Patient & Caregiver Survey, will be submitted to the FDA and released to the public later this summer.
To register for the June 8, 2018 meeting or for more information about the AWAKE Sleep Apnea.