Contact: Theresa Shumard
Phone: 610-781-1692
mothert@sleepapnea.org
Phone: 610-781-1692
mothert@sleepapnea.org
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 www.awakesleepapnea.org.
