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
Founded in 1893, Bryn Mawr Hospital is recognized among the top hospitals in the region for its exceptional patient care. The hospital and its outpatient locations in the Philadelphia metro area offer a wide range of services, including behavioral health, cancer care, gastroenterology, orthopaedics, neurointervention and neurosurgery, cardiovascular care, maternity, bariatric surgery, urology, plastic and reconstructive surgery.
Main Line Health and Children's Hospital of Philadelphia are affiliated to provide pediatric care to our community, including 24/7 coverage of the pediatric emergency department, pediatric inpatient unit and level III neonatal intensive care unit. Main Line Health is one of the few community health systems in the region offering state-of-the-art neurointervention care. Through our collaboration with the Jefferson Hospital for Neuroscience, the hospital is a Thrombectomy-Capable Stroke Center.
Bryn Mawr Hospital offers an inpatient psychiatric program. The program serves adults with mood, anxiety and thought disorders, co-occurring substance abuse or addiction, and other psychiatric conditions. The hospital also is home to Main Line Health’s first centralized in-house Psychiatry Residency Program.
About Lankenau Heart Institute
Lankenau Heart Institute is Main Line Health’s premier comprehensive cardiovascular program, bringing together cardiologists, cardiovascular surgeons and advanced practice providers across the System’s four acute care hospitals: Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital. Through a coordinated approach, the Institute offers a full continuum of high-quality cardiovascular care — from prevention and diagnostics to clinical trials, advanced treatments and rehabilitation — with a commitment to excellence in outcomes and patient experience.
A nationally recognized leader in innovation and exceptional clinical outcomes, Lankenau Heart Institute is at the forefront of minimally invasive and transcatheter procedures for coronary revascularization, valve repair and replacement, complex aortic surgery and the treatment of advanced heart failure and arrhythmias. Its pioneering work in robotic-assisted and beating-heart techniques and minimally invasive and robotic valve repair continues to shape the future of cardiovascular care. With a robust and influential presence in national clinical trials, its physicians regularly participate in groundbreaking research focused on new therapies, technologies and procedures, primarily through less invasive approaches.
About Main Line Health
Main Line Health® is a not-for-profit health system serving the greater Philadelphia region. The System comprises five hospitals, seven health centers, more than 160 outpatient and physician practice locations, over 14,500 employees and more than 2,200 employed and independent physicians and advanced practice providers.
Founded in 1985, Main Line Health includes four of the region’s most respected acute care hospitals — Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital — as well as Bryn Mawr Rehab Hospital, one of the nation’s premier facilities for rehabilitative medicine. The System also includes Mirmont Treatment Center, which provides treatment and support for substance use disorders; Main Line Health HomeCare & Hospice; Main Line HealthCare, its employed multispecialty physician network; Lankenau Institute for Medical Research, a leading biomedical research organization; and Main Line Health Centers offering primary and specialty care, lab, radiology and other outpatient services in Broomall, Collegeville, Concordville, Devon, Exton, King of Prussia and Newtown Square.
Main Line Health brings together physicians, advanced practice providers, nurses, researchers and other healthcare professionals across a broad network of inpatient, outpatient, home-based and community-based services. Through this integrated approach, the System delivers high-quality, comprehensive care across the continuum — from primary care and preventive services to complex specialty, surgical, trauma, emergency, rehabilitative, behavioral health, home care and hospice services — with a focus on making care accessible in the communities where people live and work.
Main Line Health also collaborates with leading clinical partners to expand access to specialized care. Through its affiliation with Children's Hospital of Philadelphia, pediatric care is provided at select Main Line Health locations, including neonatal intensive care units at its acute care hospitals and Bryn Mawr Hospital’s Inpatient Pediatric Unit and Emergency Department. Jefferson Health neurosurgeons and neurointerventionalists also provide 24/7 specialized care, including neurointervention and lifesaving stroke care.
Contact
Phil Ellingsworth, Jr.Director, Communications
Office: 484.580.1182
EllingsworthPh@mlhs.org