S.I.Le.N.C.E. Clinical Study

S.I.Le.N.C.E. Clinical Study for Elevoplasty®

The S.I.Le.N.C.E. Clinical Study was a multi-center clinical trial to evaluate the safety and efficacy of Snoring Intervention via Elevoplasty® in a Non-surgical Clinical Environment (S.I.Le.N.C.E.).

A new office-based procedure for treatment of snoring: The S.I.Le.N.C.E. study

Michael Friedman MD, M. Boyd Gillespie MD, MSc, Faramarz A. Shabdiz MD, David H. Hiltzik MD, Ted A. Meyer MD, PhD, Jeffrey Ahn MD, Peter J. Catalano MD, Ninos J. Joseph BS

Abstract

Objective: Demonstrate the safety and effectiveness of palatal foreshortening and stiffening in reducing snoring severity in nonobstructive sleep apnea (non-OSA) patients complaining of chronic disruptive snoring.

Methods: In a US-based 8-center, open-label, prospective, single-arm cohort study, 52 consenting adults with chronic disruptive snoring (snoring impacting a patient’s life and causing patient or bed partner to seek medical intervention) were treated via office based placement of resorbable, bidirectional, barbed suture implants into the soft palate under local anesthesia. Prior to intervention, home sleep tests (HSTs) were performed to rule out OSA and to document snoring noise level. Both subject and their bed/sleep partners (also consented) completed questionnaires including: bed/sleep partner’s scored visual analog scale (VAS) for subjects’ snoring severity, and subject scoring for Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI). Following intervention, HSTs, VAS, ESS and PSQI were repeated at 30, 90 and 180 days.

Results: Mean baseline bed/sleep partner VAS was 7.81 ± 1.59. Mean postimplant VAS scores decreased significantly at each measured interval; to 5.77±2.35 (P < .001) at 30 days, 4.48 ± 1.81 (P < .001) at 90 days, and 5.40 ± 2.28 (P < .001) at 180 days. Post treatment improvements in daytime sleepiness and QOL were also observed. Two partial extrusions were reported. No further adverse events were identified.

Conclusion: The current study demonstrates the safety and efficacy of the Elevoplasty procedure in reducing snoring severity over a follow-up period of 6 months.

Level of Evidence: 2b

A full copy of this peer-reviewed publication can be found at:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042659/

or a downloadable PDF is available here.

S.I.Le.N.C.E. Clinical Investigators

The investigators in the S.I.Le.N.C.E. Clinical Study include both academic institutions and private practitioners, among them some of the foremost thought leaders in sleep disorder treatments and international lecturers on sleep surgery in the field of otolaryngology.

Michael Friedman, MD, FACS

Principal Investigator

Dr. Friedman, Principal Investigator of the S.I.Le.N.C.E. Clinical Study, is Chairman of Otolaryngology – Head and Neck Surgery at Advocate Illinois Masonic Medical Center in Chicago, IL, Professor of Otolaryngology at Rush University Medical Center, and Medical Director of ChicagoENT, a multi-physician private practice with locations in and around the greater Chicago, IL area. Since 1977, Dr. Friedman has practiced as an ear, nose, and throat doctor in the Chicago area, and has earned recognition from peers and patients alike. Dr. Friedman is also a nationally known expert on head and neck cancer, endoscopic sinus surgery, thyroid and parathyroid surgery, and sleep disorders. Over the past 30 years, Dr. Friedman has trained countless surgeons, fellows, residents, and medical students. He has published more than 200 scientific articles and has co-authored many book chapters and textbooks on snoring, sleep apnea, and thyroid and parathyroid surgery. He is the editor-in-chief of what many consider to be the field’s definitive textbook, Sleep Apnea and Snoring: Surgical and Non-Surgical Therapy.

M. Boyd Gillespie, MD, FACS, MSCR

Clinical Investigator

Dr. Gillespie is Professor and Chair of Otolaryngology – Head & Neck Surgery at UTHSC and Methodist University Hospital. He is originally from Anderson, SC and is a graduate of Davidson College and the Johns Hopkins University School of Medicine where he completed his residency and fellowship in otolaryngology – head & neck surgery. Dr. Gillespie earned a Masters in Clinical Research at the Medical University of South Carolina, and is board certified in otolaryngology and sleep medicine. He was among the first U.S. surgeons to perform salivary endoscopy and has educated many of the surgeons in the U.S. who currently perform the technique. He has published over 130 academic papers including the New England Journal of Medicine study of hypoglossal nerve stimulation for sleep apnea. He is also the senior author of the only peer-review published study investigating the use of resorbable barbed suture in the soft palate as a treatment for snoring: TranQuill sling snoreplasty for snoring: A single-arm pilot study for safety and effectiveness.

Faramarz Shabdiz, MD

Clinical Investigator

Dr. Shabdiz is a board certified otolaryngologist and head and neck surgeon. He completed his residency at the University of Southern California and graduated with top honors. He completed a research fellowship at Harvard Medical School at Massachusetts Eye and Ear Infirmary, focused on facial plastics and ear surgery, and performed research in the genetics of congenital ear anomalies. He has over 18 years of surgical experience in facial plastics, sinus, ear, and head and neck surgery. Dr. Shabdiz is affiliated with St. Joseph Hospital, La Veta Surgical Center and Children’s Hospital of Orange County.

David Hiltzik, MD, FACS

Clinical Investigator

Dr. Hiltzik is the Director of the Division of Otolaryngology and Head & Neck Surgery at Staten Island University Hospital, as well as Assistant Clinical Professor in Otolaryngology and Head and Neck Surgery at Columbia University, College of Physicians & Surgeons. He has a sub-specialization in cranial base and reconstructive surgery. He treats general disorders of the ears, nose and throat with a focus on skull base and facial plastic surgery. He is also Medical Director of the North Shore-LIJ Sleep Disorders Center, and the Division of Pulmonary, Critical Care and Sleep Medicine Department at North Shore-LIJ. He is the Program Director of the Hofstra North Shore-LIJ Sleep Medicine Fellowship Program, and serves as a Professor of Medicine at the Hofstra North Shore-LIJ School of Medicine. He received his medical degree from the Mount Sinai School of Medicine and completed his residency and fellowship training at Columbia University, College of Physicians & Surgeons.

Ted Meyer, MD, PhD

Clinical Investigator

Dr. Meyer joined the Department of Otolaryngology – Head and Neck Surgery at Medical University of South Carolina (MUSC) in 2004 and is Director of the MUSC Cochlear Implant Program. In 1995, he graduated from the medical scholars program at the University of Illinois College of Medicine in Urbana-Champaign with a medical degree and a doctoral degree from the Department of Speech & Hearing Science. He then completed a residency in otolaryngology – head and neck surgery at Indiana University, followed by a fellowship in neurotology at the University of Iowa before joining the faculty at MUSC. His specialty areas include hearing loss, cochlear implants, tympanic membrane perforations, cholesteatoma, otosclerosis, vertigo, Meniere’s disease, facial paralysis, congenital ear malformations, acoustic neuromas, glomus tumors and other skull base lesions. As Director of the MUSC Cochlear Implant Program, he oversees all clinical and research protocols involving patients with cochlear implants. Dr. Meyer has published numerous manuscripts and book chapters. He has received several grants to study mechanisms of speech perception with cochlear implants and he is involved in many clinical trials. He frequently presents his results at national and international research meetings. He is also a fellow of the American Academy of Otolaryngology – Head and Neck Surgery.

Jeffrey Ahn, MD

Clinical Investigator

Dr. Ahn is Medical Director at Park Avenue Sinus & Sleep Center. He is a double board certified surgeon in otolaryngology – head & neck surgery and facial plastic & reconstructive surgery. Dr. Ahn has performed over 4,000 endoscopic sinus surgeries. He is one of the first surgeons in the world to perform robotic surgery for obstructive sleep apnea. Dr. Ahn currently serves as a clinical faculty member in the Department of Otorhinolaryngology – Head and Neck Surgery at the University of Pennsylvania, Perelman School of Medicine. Dr. Ahn received his medical degree from Columbia University, completed his residency training in otolaryngology – head & neck surgery at Columbia University Medical Center, and his fellowship training in facial plastic and reconstructive surgery at New York University. Over the course of his 20-year career at Columbia’s College of Physicians & Surgeons, Dr. Ahn served as Director of Resident Training, Director of Facial Plastic Surgery, and Director of Sleep Disorder & Robotic Surgery in the Department of Otolaryngology – Head & Neck Surgery for ten years. Dr. Ahn was among the first surgeons in the world to perform da Vinci® Trans-Oral-Robotic Surgery (TORS) for obstructive sleep apnea, and is responsible for the successful establishment of the TORS Program for Obstructive Sleep Apnea at Columbia. He collaborates with Dr. Jeremy Mao in tissue engineering research at Columbia’s Center for Craniofacial Regeneration, under a grant from the National Institute of Health.

Peter Catalano, MD, FACS, FARS

Clinical Investigator

Dr. Catalano is Chief of Otolaryngology and Medical Director of Research at St. Elizabeth’s Medical Center in Brighton, MA. He is affiliated with Lahey Hospital and Medical Center. Dr. Catalano received his medical degree from Icahn School of Medicine at Mount Sinai and has been in practice for more than 20 years. He is a frequent international lecturer on minimally-invasive ENT procedures, and runs several popular annual physician conferences on topics relating to minimally-invasive otolaryngology procedures.