With an unmatched level of investment in clinical research and product development, SomnoMed® is committed to clinically validating and ensuring our devices’ comfort, quality, compliance and efficacy. There are more than 15 clinical publications reporting efficacy, compliance and outcomes data for oral appliances (OA) compared to CPAP and most trials compared CPAP and OA for their ability to reduce AHI. The key findings of these combined studies were:
- No difference in treating apnea at two years
- OA preferred treatment
- OA better treatment compliance
- OA non-inferior to CPAP on blood pressure
- CPAP & OA lowered morning blood pressure
The company continues to study the clinical efficacy, comfort and quality of SomnoDent devices.
Clinical Research Articles
Summary of Key Clinical Research Findings
Biao Zeng, MD, PhD, Andrew T. Ng, MBBS, Jin Qian, MBiomedEng, Peter Petocz, PhD, M. Ali Darendaliler, PhD, Peter A Cistulli, MBBS, PhD SLEEP 2008; 31 (4): 543 – 547. Centre for Sleep Health & Research, Department of Respiratory Medicine, Royal North Shore Hospital, University of Sydney, Australia.
- Oral Appliance therapy in Obstructive Sleep Apnea-Hypopnea syndrome – A clinical study on therapeutic outcomes
A Hoekema PhD thesis, University Medical Centre Groningen Department of Oral and Maxillofacial Surgery. pp 110 (2007)
Chan AS, Lee RW, Cistulli PA CHEST. 2007 Aug; 132(2): 693-9. Centre for Sleep Health and Research, Royal North Shore Hospital, St Leonards NSW 2065, Australia.
Zeng B, Ng AT, Darendeliler MA, Petocz P, Cistulli PA. Am J Respir Crit Care Med. 2007 Apr 1;175(7):726-30. Centre for Sleep Health and Research, Department of Respiratory Medicine, Royal North Shore Hospital, University of Sydney, Sydney, Australia.
- Position paper on the use of mandibular advancement devices in adults with sleep-related breathing disorders
Susanne Schwarting & Ulrich Huebers & Markus Heise & Joerg Schlieper & Andreas Hauschild
Published online: 27 April 2007 # Springer-Verlag 2007
A position paper of the German Society of Dental Sleep Medicine (Deutsche Gesellschaft Zahnaerztliche Schlafmedizin, DGZS)
Lim J, Lasserson TJ, Fleetham J, Wright J.
Cochrane Database Syst Rev. 2006 Jan 25
Royal Surrey County Hospital, Guildford, Surrey, UK.
- Practice Parameters for the Treatment of Snoring & Obstructive Sleep Apnea with Oral Appliances_An Update for 2005
Kushida CA; Morgenthaler TI; Littner MR et al. An American Academy of Sleep Medicine Report —AASM Practice Parameters. An Update for 2005. SLEEP 2006; 29(2): 240-243
- Case Control Study in the Treatment of Obstructive Sleep-Disordered Breathing with a Mandibular Protrusive Appliance
Edmund C. Rose1, Martin Germann2, Stephan Sorichter2, Irmtrud E. Jonas1 Department of Orthodontics, University of Freiburg i. Br., Germany, Department of Pneumology, Sleep Laboratory, University of Freiburg English version revised by Carol Cürten, Freiburg/Br. Received: July 2, 2004; accepted: September 6, 2004
- Oral appliance therapy reduces blood pressure in obstructive sleep apnea_a randomized, controlled trial
Gotsopoulos H, Kelly JJ, Cistulli PA. Sleep. 2004 Aug 1;27(5):934-41. Department of Respiratory & Sleep Medicine, St George Hospital, The University of New South Wales, Sydney Australia.
Ng AT, Gotsopoulos H, Qian J, Cistulli PA. Am J Respir Crit Care Med. 2003 Jul 15;168(2):238-41 Department of Respiratory Medicine, St. George Hospital, Belgrave Street, Kogarah, NSW 2217, Australia.
Andrew J. Pitsis, M. Ali Darendeliler, Helen Gotsopoulos, Peter Petocz and Peter A. Cistulli Am. J. Respir. Crit. Care Med. 2002 Sep 15;166 (6): 860-4 Department of Respiratory Medicine, Centre for Sleep Disorders and Respiratory Failure, St. George Hospital, University of New South Wales, Kogarah; Discipline of Orthodontics, Faculty of Dentistry, University of Sydney; and Department of Mathematical Sciences, University of Technology, Sydney, New South Wales, Australia
- An individually adjustable oral appliance vs continuous positive airway pressure in mild-to-moderate obstructive sleep apnea syndrome
Randerath WJ, Heise M, Hinz R, Ruehle KH. Klinik Ambrock, Hagen, CHEST. 2002 Aug;122, Germany.
- 4-year follow-up of treatment with dental appliance or uvulopalatopharyngoplasty in patients with obstructive sleep apnea_a randomized study.
Walker-Engström ML, Tegelberg A, Wilhelmsson B, Ringqvist I. CHEST. 2002 Mar;121(3):739-46. Center for Clinical Research, Central Hospital, Västerås, Uppsala University, Sweden.
Helen Gotsopoulos, Carol Chen, Jin Qian and Peter A. Cistulli Am. J. Respir. Crit. Care Med., Vol 166. pp. 743-748, (2002) © 2002 American Thoracic Society Department of Respiratory Medicine, Centre for Sleep Disorders and Respiratory Failure, St. George Hospital, University of New South Wales, Kogarah, Australia
Atul Mehta, Jin Qian, Peter Petocz, M. Ali Darendeliler, And Peter A. Cistulli Am. J. Respir. Crit. Care Med., Volume 163, Number 6, May 2001, 1457-1461 Centre for Sleep Disorders and Respiratory Failure, Department of Respiratory Medicine, St George Hospital, University of New South Wales, Discipline of Orthodontics, Faculty of Dentistry, University of Sydney, and School of Mathematical Sciences, University of Technology, Sydney, Australia
Cistulli PA, Palmisano RG, Poole MD. SLEEP. 1998 Dec 15;21(8):831-5 Centre for Sleep Disorders & Respiratory Failure, St George Hospital, NSW, Australia.