University Hospitals Sleep Medicine Research Highlights
November 11, 2020
Innovations in Pulmonology & Sleep Medicine | Fall 2020
Kingman Strohl, MD, is senior author in a publication of the multicenter Phase 3 study of SUNOSI™ (Solriamfetol), a first in class Norepinephrine- and Dopamine-reuptake inhibitor. This study evaluated its safety and efficacy in the treatment of excessive daytime sleepiness for patients with obstructive sleep apnea, and led to FDA approval. This is the second drug available for excessive daytime sleepiness in obstructive sleep apnea and narcolepsy.
UPPER AIRWAY STIMULATION THERAPY
Mark Scher, MD and Dr. Strohl are co-authors in a publication related to post-approval registries for upper airway stimulation therapy. Safety and efficacy were similar in the first 10 compared to the second 10 implants in both original and new centers for this therapy, indicating a success of the intensive training provided to an ENT surgeon. Another study in abstract form was a reanalysis of data from the Phase 3 study showing that the higher the NREM to REM AHI ratio the higher the odds of success after implant. The result is probably related to the criteria for selection.
AERSLEEP AS CPAP ALTERNATIVE
Dr. Strohl and Eric Yeh, MD, are preparing to participate in a multicenter trial of a novel therapy, aerSleep, a CPAP alternative for those who are intolerant of CPAP or use CPAP infrequently. Basic studies are underway of the mechanisms for how negative pressure applied by a collar around the neck opens the airway enough to improve sleep apnea. Of note, this physiology was first demonstrated in animal studies by Dr. Strohl in 1987. The Phase 3 trial of aerSleep should be available for recruitment at University Hospitals Cleveland Medical Center in the second quarter of 2021.
BELUN RING HOME SLEEP APNEA TESTING
Ambrose Chiang, MD, is leading a team conducting another Belun Ring Platform (BLS-100) validation study to evaluate the accuracy of the newly improved Belun Ring algorithm in assessing obstructive sleep apnea (OSA). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based home sleep apnea testing (HSAT) platform consisting of a size adjustable ring shape pulse oximeter sensor, a cradle and an improved proprietary cloud-based analytic algorithm. This study investigates whether the BLS-100 is a reasonable home sleep apnea testing device for OSA assessment in patients referred to sleep labs for assessment of OSA whose STOP-Bang score is > 3. The Belun Ring captures oxygen saturation, photoplethysmography and accelerometer signals. The Belun Ring with the original algorithm demonstrated to be a good clinical tool with reasonable accuracy in predicting the severity of OSA in its first three trials in Hong Kong, Colorado and UH Cleveland Medical Center.
DIGITAL ADAPTIVE PSYCHOPHYSICS DEVICE
John Andrefsky, MD, and colleagues in UH Cleveland Medical Center neurology and sleep departments are now enrolling patients in a study that uses a digital adaptive psychophysics device, Cognivue, to assess whether CPAP can improve cognitive impairment in patients with sleep apnea. Patients having diagnostic polysomnograms are currently being enrolled and will be followed for one year after they have been placed on CPAP to see if cognitive impairment has improved. While patients with sleep apnea often have excessive daytime sleepiness, it has been difficult in the past to assess the cognitive performance of sleep patients as this requires lengthy and expensive neuropsychiatric testing.
University Hospitals now has the technology to provide tele-sleep services to hospitals in underserved areas. This technology allows doctors at UH to provide high quality sleep care for patients with limited access to sleep physicians. Patients can be seen remotely at multiple designated locations, and have their sleep studies read remotely as well. This system allows for more rapid diagnosis and treatment of patients with sleep apnea or a wide variety of other sleep disorders. With recent changes in reimbursement, patients can even be seen in the comfort of their own home for treatment of sleep problems.
PEDIATRIC SLEEP RESEARCH
Kristie Ross, MD and Sally Ibrahim, MD, along with Carol Rosen, MD (emeritus), are leading local efforts for the Pediatric Adenotonsillectomy Trial for Snoring (PATS), a national multi-center randomized control study to assess the impact of treatment of mild sleep-disordered breathing on children’s health. The same group is assessing the treatment of obstructive sleep apnea in patients with Down syndrome in an observational trial called HELP-DS. The Sleep Center team of University Hospitals Rainbow Babies & Children’s Hospital is also working to join national efforts to establish the first prospective narcolepsy database that will serve to enhance knowledge and future directions in narcolepsy-related research. Lastly, this team is assessing a virtual platform app to enhance patient experience and health goals by using educational instruments and patient care reminders between appointments.
For more information or to refer a patient, call 216-844-REST (216-844-7378).