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 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.
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 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,” says Chandhok, an electrophysiologist with Bryn Mawr Medical Specialists Association and a member of Lankenau Heart Institute, in a release. “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.”
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 says.
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.