Bryn Mawr Hospital first site in world to enroll patient and complete protocol in landmark JANUS trial for sleep apnea
Bryn Mawr Hospital, part of Main Line Health’s Lankenau Heart Institute, on August 18, 2020 became the first site in the world to successfully enroll a patient and complete the protocol in JANUS, a landmark clinical trial for sleep apnea. The trial seeks to explore whether transvenous stimulation can improve airway physiology. In this first patient, Sheetal Chandhok, MD, the investigator and implanting physician, was able to demonstrate feasibility in this novel approach for managing sleep apnea.
Sleep apnea---when prolonged pauses in breathing occur during sleep---is a serious health issue for many Americans. An estimated 22 million Americans suffer from some degree of sleep apnea, a condition that causes breathing to abruptly stop and restart during sleep. In addition to poor sleep quality, sleep apnea can lead to high blood pressure, heart failure, atrial fibrillation, stroke and other health issues.
The primary objective of the JANUS trial, sponsored by Respicardia, is to assess acute changes in respiration and airway physiology during sleep. The trial is being conducted in patients with central sleep apnea who are undergoing a Remedé system implant, which uses transvenous stimulation to reduce the periods of the breathing pauses. The JANUS trial is conducted during the implantation of commercially available device called the Remede® System, a diaphragm pacemaker that works to stimulate breathing in the same way that the brain would. The Remede® System was first implanted at Bryn Mawr Hospital by Dr. Sheetal Chandhok, a cardiac electrophysiologist, in January 2019.
“Central sleep apnea occurs when the brain temporarily stops sending signals to the muscles that control our breathing. When that happens, this pacemaker (the Remede® System) sends a signal to the phrenic (diaphragm) nerve to trigger breathing. This prevents the risk of interrupted breathing at night, and currently is the only approved treatment for central sleep apnea,” explains Sheetal Chandhok, MD, an electrophysiologist with Bryn Mawr Medical Specialists Association and a member of Lankenau Heart Institute. “In the JANUS trial we hope to show that an alternative transvenous lead location can affect respiration and airway physiology during a commercial Remedē® System implant procedure”.
Dr. Chandhok is one of three primary investigators for the JANUS trial and was the first clinician in the world to enroll a subject and complete the objective for the trial. “The potential success of JANUS trial may have far-reaching implications for a broader set of sleep apnea patients for whom there are only limited treatments,” he said.
The JANUS trial is currently enrolling subjects who are undergoing transvenous phrenic nerve stimulation for moderate to severe central sleep apnea using the Remedē® System. Participants must be over 18. To learn more about this trial or to enroll, visit clinicaltrials.gov.
About Bryn Mawr Hospital
Bryn Mawr Hospital, part of Main Line Health, is a 284-bed, not-for-profit acute care teaching hospital dedicated to helping the community stay well ahead on the path to lifelong health. Bryn Mawr Hospital has received both regional and national recognition for its excellence in providing state-of-the-art, quality care. U.S. News & World Report’s Best Hospitals 2022–2023 rated Bryn Mawr Hospital as High Performing in six commonly occurring conditions and medical procedures and earned two coveted Adult Specialty ratings. The hospital offers a full range of services, including cancer care, orthopaedic care, cardiovascular care, behavioral health, maternity care, bariatric surgery, neurovascular and a level III neonatal intensive care unit, all aided by a dedicated team of health care professionals and innovative technologies. Through Bryn Mawr Hospital's collaboration with the Jefferson Hospital for Neuroscience, the university-affiliated neurointervention center is an accredited thrombectomy-capable stroke center that offers rapid access to advanced diagnostics and treatment options for stroke care. Bryn Mawr Hospital is affiliated with the Children's Hospital of Philadelphia (CHOP) to deliver exceptional care for pediatric patients and their families, including 24/7 coverage of the pediatric emergency department, pediatric inpatient unit and level III NICU.
About Lankenau Heart Institute
The Lankenau Heart Institute is Main Line Health's premier comprehensive cardiovascular medicine and surgery program. Lankenau Heart Institute brings together the clinical expertise of all four Main Line Health acute care hospitals and both the employed and community cardiology practices to ensure that patients receive a level of quality, service and experience that is unparalleled in the region. Through the systemwide coordination of services, Lankenau Heart Institute delivers preventive, diagnostic, therapeutic and rehabilitative cardiovascular services at each of our locations including Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital.
Lankenau Heart Institute continues to be an innovator in the use of beating-heart techniques and robotic-assisted procedures for coronary artery revascularization, minimally invasive and transcatheter approaches for valve repair and replacement, complex aortic surgery and heart rhythm disorders. With our growing experience and focus on minimally invasive techniques, Lankenau Heart Institute has expanded participation in clinical trials year after year. Our physicians are frequently invited to participate in clinical/medical device trials, many of which are designed to facilitate the use of minimally invasive approaches and procedures.
With a collaborative team of expert consultative cardiologists, interventional cardiologists, electrophysiologists, cardiovascular surgeons and specially trained advance practice nurses and technologists, Lankenau Heart Institute is dedicated to managing and treating patients with simple to complex cardiovascular disease, including heart failure, aortic disease, coronary and peripheral vascular disease, lipid and genetic abnormalities, heart rhythm disorders and valve disease. Our team of cardiologists and cardiac and vascular specialists provide patients and their families with expert cardiovascular care, close to home.
About Main Line Health
Founded in 1985, Main Line Health is a not-for-profit health system serving Philadelphia and its suburbs. Main Line Health's commitment — to deliver safe, high-quality, equitable and affordable care for treating and curing disease, playing an important role in prevention and disease management, as well as training physicians and other health care providers — reflects our intent to be the region's premier choice for clinical care, research, and education. A team of more than 13,000 employees and over 3,500 employed and independent physicians and advanced practice providers care for patients throughout Main Line Health.
At Main Line Health's core are four of the region's most respected acute care hospitals — Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital — as well as one of the nation's premier facilities for rehabilitative medicine, Bryn Mawr Rehab Hospital.
Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare, one of the region's largest multispecialty physician networks.
Main Line Health is the recipient of numerous awards for quality care and service, including the prestigious American Hospital Association Quest for Quality Prize, highest tier ratings from the Centers for Medicare & Medicaid Services (CMS) for Overall Hospital Quality and systemwide recognition in the 2023-2024 U.S. News & World Report Best Hospitals rankings. Main Line Health is committed to creating an environment of diversity, respect, equity and inclusion, has proudly received awards in this area and has embraced the American Hospital Association's #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education and research to help patients stay healthy and live their best lives.
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