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. Clinical evidence of COAT is available with the links below.

Download the COAT™ Bibliography and Clinical Research

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
Sleep physicians should consider prescription of COAT for patients with obstructive sleep apnea who are intolerant of CPAP therapy or prefer alternate therapy – regardless of severity. American Academy of Sleep Medicine – Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015.

Clinical Evidence: Review Articles

A crossover randomized controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea.Timothy Quinnell, Maxine Bennett, Jake Jordan, Abigail Clutterbuck-James, Michael Davies, Ian Smith, Nicholas Oscroft, Marcus Pittman, Malcolm Cameron, Rebecca Chadwick, Mary Morrell, Matthew Glover, Julia Fox-Rushby, Linda Sharples. Thorax 2014 Oct;69(10): 938-45. http://www.ncbi.nlm.nih.gov/pubmed/17136406The comparison of CPAP and oral appliances in treatment of patients with OSA: a systematic review and meta-analysis. Li W1, Xiao L, Hu J. Respir Care. 2013 Jul;58(7):1184-95. http://www.ncbi.nlm.nih.gov/pubmed/23287015Oral Appliance Treatment for Obstructive Sleep Apnea: An Update. Sutherland K, Vanderveken O, Tsuda H, Marklund M, Gagnadoux F, Kushida C, Cistulli P, Source, Journal of Clinical Sleep Medicine, Vol 10 No 2, 2014. http://www.ncbi.nlm.nih.gov/pubmed/24533007

Evidence for Clinical Efficacy/Preference

CPAP vs. Mandibular Advancement Devices and Blood Pressure in Patients With Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Bratton DJ, Gaisl T, Wons A<, Kohler M, JAMA. 2015 Dec 1; 314(21):2280-93 http://www.ncbi.nlm.nih.gov/pubmed/26624827Meta-analysis of randomized controlled trials of oral mandibular advancement devices and continuous positive airway pressure for obstructive sleep apnoea-hypopnoea. Linda Sharples, Abigail Clutterbuck-James, Matthew Glover, Maxine Bennett, Rebecca Chadwick, Marcus Pittman, Timothy Quinnell. Sleep Med Review 2015 May 30; http://www.ncbi.nlm.nih.gov/pubmed/26163056Exploring the Potential Cost-Effectiveness of Patient Decision Aids for Use in Adults with Obstructive Sleep Apnea: A Case Study. Logan Trenaman, Mohsen Sadatsafavi, Fernanda Almeida, Najib Ayas, Larry Lynd, Carlo Marra, Dawn Stacey, Nick Bansback. Med Decision Making. 2015 Jul: 35(5): 671-82. http://www.ncbi.nlm.nih.gov/pubmed/25344130Effects of treatment with oral appliance on 24-h blood pressure in patients with obstructive sleep apnea and hypertension: a randomized clinical trial. Andrén A1, Hedberg P, Walker-Engström ML, Wahlén P, Tegelberg A. Sleep Breath. 2013 May;17(2):705-12. http://www.ncbi.nlm.nih.gov/pubmed/22821223Patient preferences and experiences of CPAP and oral appliances for the treatment of obstructive sleep apnea: a qualitative analysis. Almeida FR1, Henrich N, Marra C, Lynd LD, Lowe AA, Tsuda H, Fleetham JA, Pliska B, Ayas N. Sleep Breath. 2013 May;17(2):659-66. http://www.ncbi.nlm.nih.gov/pubmed/22833346Mandibular advancement splint as short-term alternative treatment in patients with obstructive sleep apnea already e_ectively treated with continuous positive airway pressure. Almeida FR1, Mulgrew A, Ayas N, Tsuda H, Lowe AA, Fox N, Harrison S, Fleetham JA. J Clin Sleep Med. 2013 Apr 15;9(4):319-24. http://www.ncbi.nlm.nih.gov/pubmed/23585745Mandibular advancement appliances remain effective in lowering respiratory disturbance index for 2.5-4.5 years. Gauthier L1, Laberge L, Beaudry M, Laforte M, Rompré PH, Lavigne GJ., Sleep Med. 2011 Oct;12(9):844-9. doi: 10.1016/j.sleep.2011.05.004. Epub 2011 Sep 16. http://www.ncbi.nlm.nih.gov/pubmed/21925942Dental appliance treatment for obstructive sleep apnea. Chan AS, Lee RW, Cistulli PA. Centre for Sleep Health and Research, Royal North Shore Hospital, St Leonards NSW 2065, Australia.CHEST. 2007 Aug;132(2): 693-9. http://www.ncbi.nlm.nih.gov/pubmed/17699143Long-term compliance and side e_ects of oral appliances used for the treatment of snoring and obstructive sleep apnea syndrome. de Almeida FR1, Lowe AA, Tsuiki S, Otsuka R, Wong M, Fastlicht S, Ryan F. J Clin Sleep Med. 2005 Apr 15;1(2):143-52. http://www.ncbi.nlm.nih.gov/pubmed/17561628

Clinical Evidence for Improved Outcomes

Alternatives to continuous positive airway pressure 2: mandibular advancement devices compared. Quinnell TG1, Clutterbuck-James AL. Curr Opin Pulm Med. 2014 Nov;20(6):595-600. http://www.ncbi.nlm.nih.gov/pubmed/25221854Modulation of Inflammatory and Hemostatic Markers in Obstructive Sleep Apnea Patients Treated with Mandibular Advancement Splints: A Parallel, Controlled Trial. Nizankowska-Jedrzejczyk A1, Almeida FR2, Lowe AA2, Kania A3, Nastałek P3, Mejza F3, Foley JH4, Nizankowska-Mogilnicka E3, Undas A5. J Clin Sleep Med. 2014 Mar 15;10(3):255-62. http://www.ncbi.nlm.nih.gov/pubmed/24634622Mandibular Advancement device and CPAP upon cardiovascular parameters in OSA. Cibele Dal-Fabbro, Silvério Garbuio, Vânia D’Almeida, Fátima D. Cintra, Sergio Tu_k, Lia Bittencourt. Sleep. 2014 January 26. http://www.ncbi.nlm.nih.gov/pubmed/24463982Cardiovascular mortality in obstructive sleep apnea treated with continuous positive airway pressure or oral appliance: An observational study. Anandam A, Patil M, Akinnusi M, Jaoude P, El-Solh AA. Respirology. 2013 Nov; 18(8): 1184-90. http://www.ncbi.nlm.nih.gov/pubmed/23731062Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Phillips CL1, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, Marks GB, Cistulli PA. Am J Respir Crit Care Med. 2013 Apr 15; 187(8):879-87. http://www.ncbi.nlm.nih.gov/pubmed/23413266Improvement of Cognitive and Psychomotor Performance in Patients with Mild to Moderate Obstructive Sleep Apnea Treated with Mandibular Advancement Device: A Prospective 1-Year Study Tea Galic, DMD1; Josko Bozic, MD2; Renata Pecotic, MD, PhD3,4; Natalija Ivkovic, MSc, RN3; Maja Valic, MD, PhD3,4; Zoran Dogas, MD, PhD3,4 https://www.ncbi.nlm.nih.gov/pubmed/26414974 Effect of oral appliances on blood pressure in obstructive sleep apnea: a systematic review and meta-analysis. Iftikhar IH1, Hays ER, Iverson MA, Magalang UJ, Maas AK. J Clin Sleep Med. 2013 Feb 1;9(2):165-74. http://www.ncbi.nlm.nih.gov/pubmed/23372472Effect of oral appliance therapy on neurobehavioral functioning in obstructive sleep apnea: a randomized controlled trial. Naismith SL1, Winter VR, Hickie IB, Cistulli PA. J Clin Sleep Med. 2005 Oct 15;1(4):374-80. http://www.ncbi.nlm.nih.gov/pubmed/17564405Oral appliance therapy reduces blood pressure in obstructive sleep apnea: a randomized, controlled trial. Gotsopoulos H, Kelly JJ, Cistulli PA. Department of Respiratory & Sleep Medicine, St George Hospital, The University of New South Wales, Sydney Australia Sleep. 2004 Aug 1;27(5):934-41. http://www.ncbi.nlm.nih.gov/pubmed/15453552

Clinical Evidence: New Technology

Prediction of oral appliance treatment outcomes in obstructive sleep apnea: A systematic review Kentaro Okuno*, Benjamin T. Pliska, Mona Hamoda, Alan A. Lowe, Fernanda R. Almeida https://www.ncbi.nlm.nih.gov/pubmed/26773412Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Vanderveken OM, Dieltjens M, Wouters K, De Backer WA, Van de Heyning PH, Braem MJ.Source, Department of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium. Thorax. 2013 Jan;68(1):91-6. doi: 10.1136/thoraxjnl-2012-201900. Epub 2012 Sep 19. http://www.ncbi.nlm.nih.gov/pubmed/22993169The Use of Remotely Controlled Mandibular Positioner as a Predictive Screening Tool for Mandibular Advancement Device Therapy in Patients with Obstructive Sleep Apnea through Single-Night Progressive Titration of theMandible: A Systematic Review   Chloé Kastoer, MD1,4; Marijke Dieltjens, MSc, PhD1,2,4; Eline Oorts, MD1; Evert Hamans, MD, PhD4; Marc J. Braem, DDS, PhD2,4; Paul H. Van de Heyning, MD, PhD1,3,4; Olivier M. Vanderveken, MD, PhD1,3,4 https://www.ncbi.nlm.nih.gov/pubmed/27568892Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. Remmers J1, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Sleep. 2013 Oct 1;36(10):1517-25, 1525A. http://www.ncbi.nlm.nih.gov/pubmed/24082311Objectively measured vs self-reported compliance during oral appliance therapy for sleep-disordered breathing. Dieltjens M, Braem MJ, Vroegop AV, Wouters K, Verbraecken JA, De Backer WA, Van de Heyning PH, Vanderveken OM. Chest. 2013 Nov;144(5):1495-502. http://www.ncbi.nlm.nih.gov/pubmed/23928873