Chapel Hill, NC January 10, 2022 – Bleep, LLC, creators of the mask-free DreamPorts™ sleep solution, announced today the appointment of an Institutional Review Board (IRB) to oversee and monitor clinical studies and outcomes for their innovation in Positive Air Pressure (PAP) design for use in home and acute care/hospital settings. The creation of the Board is a requirement following the previously announced $1.7 million SBIR grant that was awarded from the National Institutes of Health (NIH) to Bleep for the development of Eclipse™, the company’s next-generation CPAP solution.
“More than 50 million adults in the U.S. have obstructive sleep apnea (OSA) and almost half of these people are non-compliant because they do not have a product that fits properly,” said Stuart Heatherington, Bleep executive chairman and DreamPorts creator. “Our latest innovation, Eclipse, builds off of the groundbreaking DreamPort® design, which eliminates headgear and addresses many of the issues identified by traditional headgear users.”
Heatherington continued, “We believe the NIH funded studies will conclude Eclipse offers ease of use, with rapid on/off application, and we expect to get the same or better results with decreased pressure, a reduction in apneas and hypopneas per hour, and improved comfort and compliance over competitive masks.”
The company believes CPAP masks have not significantly changed in design in the last 30 years and believe the Eclipse will deliver greater comfort, compliance and pressure making it easier for patients to sleep and breath.
The following people have been appointed to the Bleep IRB:
- Mary Susan Esther, MD, will serve as the Data and Safety Monitoring Board (DSMB) Chairperson.
- Esther has been involved in Sleep Medicine for over thirty years. She trained at Mayo Clinic in Rochester, Minnesota in Psychiatry and Sleep Medicine and was a member of the faculty at Mayo Clinic and later the University of Texas Health Sciences Center in San Antonio before moving to Charlotte.
- She is a diplomate of the American Board of Sleep Medicine and specialty certified in Sleep Medicine through the American Board of Psychiatry and Neurology.
- She has served as President of the North Carolina Academy of Sleep Medicine and was a past President of the American Academy of Sleep Medicine.
“CPAP compliance has been shown to improve morbidity rate, but also A1C for type 2 diabetics, mental health, and reduce cardiovascular incidence including pressure and risk of stroke. Bleep’s Eclipse® innovation is expected to be a significant game changer for patients. Compliant patients enjoy better health and reduced overall health cost. Payers and providers also benefit through reduction in ulceration penalties, post procedure recovery time and decreased readmission rates,” stated Esther.
- Christopher L. Drake, PhD, Clinical Trial Specialist will lead review of trial design and outcomes.
- He is a graduate of the Pennsylvania State University and received his PhD in Clinical Psychology from Bowling Green State University in 2001.
- Drake is a licensed Clinical Psychologist with board certification in sleep medicine and behavioral sleep medicine. He was appointed Section Head of Sleep Research for Henry Ford Health System in 2014 and is a Professor in the Department of Psychiatry and Behavioral Neuroscience at Wayne State University School of Medicine.
- His work is funded by the National Institute of Mental Health to study the effects of insomnia treatment on the prevention of depression and by the National Institute of Nursing Research for his work on behavioral treatments for insomnia.
- He has been Principal investigator on more than 20 foundation, industry, and NIH grants since 2004 and has authored over 150 publications.
- Drake has served on the Board of Directors of the Sleep Research Society and is a former Chairman of the National Sleep Foundation.
- J. Wei, PhD, will serve as the lead Biostatistician.
- Wei is a professor of Biostatistics at Harvard University and has also served as a professor at University of Wisconsin, University of Michigan, and George Washington University.
- His main research interest is in the clinical trial methodology, especially in design, monitoring and analysis of studies. He has developed numerous novel statistical methods which are utilized in practice.
- He received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology.
- He is a fellow of American Statistical Associating and Institute of Mathematical Statistics.
- He has more than 230 publications and served on numerous editorial and scientific advisory boards for governments and industry. He has extensive working experience in regulatory science for developing and evaluating new drugs/devices.
- Wei holds a PhD in Statistics from the University of Wisconsin.
With this NIH grant, Bleep, LLC will optimize their Eclipse PAP technology and produce validation data necessary for successful market commercialization expected in 2022.
About Bleep Sleep (bleepsleep.com)
Bleep Sleep Solutions, based in Chapel Hill, NC is a sleep solution company focused on improving sleep and sleep related health outcomes. The DreamPort® is a one-size-fits-all, single SKU CPAP solution with zero headgear. It has been clinically proven not to leak, eliminates mask lines and facial irritation. It is compatible with all CPAP machines and covered by all major insurance plans. DreamPort is FDA cleared, and manufactured entirely in the United States. DreamPort provides respiratory support for patients who need continuous positive air pressure solution for the treatment of sleep apnea.
