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.
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
“Health Outcomes of Continuous Positive Airway Pressure versus Oral Appliance Treatment for Obstructive Sleep Apnea – A Randomized Controlled Trial” Craig L. Phillips, Ronald R. Grunstein, M. Ali Darendeliler, Anastasia S. Mihailidou, Vansantha K. Srinivasan, Brendon J. Yee, Guy B. Marks, and Peter A. Cistulli
The company continues to study the clinical efficacy, comfort and quality of SomnoDent devices.
Click here to download the Continuous Open Airway Therapy (COAT) Full Bibliography
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 randomised 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.
The 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.
Oral 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.
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
Meta-analysis of randomised 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;
Exploring the Potential Cost-E_ectiveness 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.
Effects 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.
Patients’ with obstructive sleep apnoea syndrome (OSAS) preferences and demand for treatment: a discrete choice experiment.
Krucien N1, Gafni A, Fleury B, Pelletier-Fleury N. Thorax. 2013 May;68(5):487-8.
Patient 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.
Mandibular 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.
Complexity and e_cacy of mandibular advancement splints: understanding their mode of action.
de Almeida FR. J Clin Sleep Med. 2011 Oct 15;7(5):447-8.
Mandibular advancement appliances remain e_ective 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.
Dental 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.
Long-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.
Treatment of snoring and obstructive sleep apnea with mandibular repositioning appliances.
Peter A. Cistulli, Helen Gotsopoulos, Marie Marklund and Alan A. Lowe. Sleep Med Reviews, Vol 8 Iss 6 pp 427-499 (2004) Copyright © 2005 Elsevier Ltd.
All rights reserved.
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.
Modulation of In_ammatory and Hemostatic Markers in Obstrucive Sleep Apnea Patients Treated with Mandibular Advancment 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.
Mandibular 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.
Cardiovascular 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.
Health 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;
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.
Effect 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.
Oral 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.
Clinical Evidence: New Technology
Objective 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.
Remotely 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.
Objectively 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.