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Tuesday, May 29, 2018

Sleep Apnea Patients Seek to Inform and Accelerate Medical Product Development


Contact: Theresa Shumard
Phone: 610-781-1692

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  

Tuesday, April 24, 2018

You have a special role to play in shaping the future of treatment for sleep apnea.

Today the American Sleep Apnea Association (ASAA) is excited to announce the AWAKE Sleep Apnea initiative, an education and empowerment initiative that includes several opportunities for sleep apnea patients, family members, and caregivers to help inform researchers, regulators, and life science companies about what it’s like to live with sleep apnea. The AWAKE Sleep Apnea initiative is a collaboration of ASAA, numerous organizations, and the U.S. Food & Drug Administration (FDA). It’s the first-of-its-kind campaign to accelerate progress in patient-centered care and treatment of sleep apnea.

In order for it to succeed, we need your help – TODAY!

First, mark your calendar for June 8, 2018. This is the date of the AWAKE Sleep Apnea Patient-Focused Medical Product Development meeting taking place in the Washington, D.C.-area. You can participate in this one-day meeting in person or from the comfort of your home or office via a live webcast. We will be actively engaging patients, family members, caregivers, and advocates in a discussion of the most problematic symptoms, impacts of sleep apnea on daily life, treatment approaches, and what’s missing from care that keeps you from living your fullest. Reserve your seat (in person or by webcast) by registering here. If you’re interested in potentially speaking on a panel at the meeting, please indicate that when prompted in the registration process.

Second, share your perspective via the online AWAKE Sleep Apnea Patient & Caregiver Survey. This 31-question anonymous survey covers six key areas of the patient experience, including diagnosis, symptoms, daily impacts, treatment approaches, and greatest concerns. It takes just 15 minutes or so to complete. Responses collected between now and June 8 will help us refine the discussion on the day of the meeting. Survey results will be included in the final AWAKE Sleep Apnea report published later this summer to capture the voices of patients & caregivers from across the country. The report will be shared with FDA, life science companies, the patient community, and the public. Take the survey now.

Third, participate in a webinar on May 8 to learn more about the AWAKE Sleep Apnea initiative, the June 8 meeting, and the survey. We’ll leave plenty of time to answer your questions. Register here.

Fourth, watch for regular updates about the June 8 meeting and what we’re learning from survey respondents. Keep in touch with new developments via the AWAKE Sleep Apnea websiteASAA’s Facebook page, and Twitter feed. Learn more about our community partners & campaign sponsors, too.

Fifth, help spread the word! Forward this to family members, friends, business associates, and others who share your interest in improving sleep health. Share our posts on social media through your pages and accounts. The more people we reach, the greater our impact will be!

Sleep apnea affects as many as 18 million Americans of all ages, yet there have been relatively few forums for individuals affected by sleep apnea to share their experiences, express their treatment needs, and be heard by individuals directly involved in research, development, and regulation of medical products (including medications, medical devices, and diagnostic tests). By raising your voice through this unique campaign, you will accelerate progress for more and better options to treat sleep apnea.
Join us in support of better treatment and care for sleep apnea by taking action today!

Sincerely yours,
Adam Amdur, Chief Patient Officer
Carl Stepnowsky, PhD, Chief Science Officer
American Sleep Apnea Association
We thank these community partners and sponsors for their support of the AWAKE Sleep Apnea Initiative:

Celiac Disease Foundation:
 CMB Health Solutions
Depression and Bipolar Support Alliance
 Fisher & Paykel
 Jazz Pharmaceuticals
 Medical Device Innovation Consortium
 National Alliance for Caregiving
 Parrish Health Center
 Project Sleep