Effects of the Full Breath Solution Appliance for the Treatment of Obstructive Sleep Apnea: A Preliminary Study

Abstract

The aim of this study is to determine the effects of the Full Breath Solution (FBS) appliance in the management of obstructive sleep apnea (OSA) in 21 adults diagnosed with OSA. Oxygen saturation (SaO2) and apnea-hypopnea index (AHI) readings taken from polysomnographs (PSGs) indicated that the mean AHI fell by 73% (31.3±16.3 to 7.3±6.6, p<0.0001), and the mean SaO2 improved from 84.4%±6.7 to 88.91%±3.9 (p<0.05). While there was no change in total sleep time, the mean REM time during sleep increased from 22.0 min ± 22.3 to 47.0 min ± 29.1 (p<0.05). However, there was no change in non-REM time during sleep, or time spent in the supine position while asleep, but the arousal index decreased from 50.8±31.0 to 15.4±15.0 (p<0.001). Conclusions: The Full Breath Solution (FBS) appliance is a novel, effective approach in the management of OSA.

Additional information

Notes on contributors

G. Dave Singh

Dr. G. Dave Singh was educated and trained in England. He holds three doctorates, including a degree in dental surgery, a Ph.D. in craniofacial development, and a D.D.Sc. in orthodontics. At the Center for Craniofacial Disorders (PR), he led a NIH-funded program of craniofacial research and was awarded first prize at the International Association for Orthodontics in 2005. Dr. Singh holds two U.S. patents, has published numerous articles on clinical craniofacial development, and has lectured in Australia, Asia, Europe, and North and South America. Currently, he is the Director of the Continuing Education, SMILE Foundation, USA.

Bryan Keropian

Dr. Bryan Keropian has been a 20-year member of the Board of Directors of the American Academy of Craniofacial Pain. He served as president of the Alliance of TMD Organizations from 2007-2008. In 2002, Dr. Keropian invented the Full Breath Sleep Solution Mouthpiece and acquired patents in 2004 and 2008 for the FBS. He has acquired four FDA approvals with the FBS. Currently, he is a member of the Reimbursement Committee of the Academy of Dental Sleep Medicine.

Giora Pillar

Dr. Giora Pillar is a pediatrician and a sleep physician who graduated from the Rappaport Faculty of Medicine of the Technion- Israel Institute of Technology in Haifa. He also completed his Ph.D. in sleep research at the Technion Faculty of Medicine. Dr. Pillar obtained clinical training in pediatrics at Rambam Medical Center and completed postgraduate program at Harvard Medical School in Boston, Massachusetts. His main research and clinical interests are sleep disturbances in children, including sleep disordered breathing, movement disorders in sleep, the autonomic nervous system function during sleep, and the relationship between sleep disturbances and attention deficit hyperactive disorder. Dr. Pillar is the author of several books and book chapters in the field of pediatrics and sleep.