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Clinical Evidence

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.

NEW TECHNOLOGY
Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Related Disordered Breathing: A Prospective Clinical Trial
Dieltjens M, Verbruggen AE, Braem MJ, Wouters K, Verbraecken JA, De Backer WA, Hamans E, Van de Heyning PH, Vanderveken OM. JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):894-900.
http://www.ncbi.nlm.nih.gov/pubmed/26402736
 
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. doi:10.1378/chest.13-0613.
http://www.ncbi.nlm.nih.gov/pubmed/23928873

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.
http://www.ncbi.nlm.nih.gov/pubmed/22993169

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.
http://www.ncbi.nlm.nih.gov/pubmed/24082311

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. Sleep Med Review 2015 Dec 8;30:25-33.
https://www.ncbi.nlm.nih.gov/pubmed/26773412

The 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 J Clin Sleep Med. 2016 Oct 15;12(10):1411-1421.
https://www.ncbi.nlm.nih.gov/pubmed/27568892
 

REVIEW ARTICLES
Mandibular advancement splint (MAS) therapy for obstructive sleep apnoea — an overview and quality assessment of systematic reviews
Johal A, Fleming PS, Manek S, Marinho VC. Sleep Breath. 2015 Sep;19(3):1101-8. doi: 10.1007/s11325-015-1148-4
http://www.ncbi.nlm.nih.gov/pubmed/25778946

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.
http://www.ncbi.nlm.nih.gov/pubmed/26163056

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.
https://www.ncbi.nlm.nih.gov/pubmed/25035126

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, 2014 Feb 15;10(2):215-27
http://www.ncbi.nlm.nih.gov/pubmed/24533007
 

EVIDENCE FOR CLINICAL EFFICACY/PATIENT PREFERENCE
Mandibular advancement splint as short-term alternative treatment inpatients with obstructive sleep apnea already effectively 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/23585745

Efficacy versus Effectiveness in the Treatment of Obstructive Sleep Apnea: CPAP and Oral Appliances 
Kate Sutherland, PhD1,2; Craig L. Phillips, PhD1,2; Peter A. Cistulli, MD, PhD1Journal of Dental Sleep Medicine. 2015; 2(4):175-181.
http://www.jdsm.org/ViewArticle.aspx?pid=30229

 
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.
http://www.ncbi.nlm.nih.gov/pubmed/22833346 

Long-term compliance and side effects 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 

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. 
http://www.ncbi.nlm.nih.gov/pubmed/17699143 

Exploring 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/25344130 

 
Effect of jaw-opening exercise on prevention of temporomandibular disorders pain associated with oral appliance therapy in obstructive sleep apnea patients: A randomized, double-blind, placebo-controlled trial 
Hiroyuki Ishiyama DDS, Shusuke Inukai DDS, PhD, Akira Nishiyama DDS, PhD, Masayiki Hideshima DDS, PhD, Shuhei Nakamura DDS, PhD, Meiyo Tamaoka, PhD, Yasunari Miyazaki MD, PhD, Kenji Fueki DDS, PhD, Noriyuki Wakabayashi DDS, PhD Journal of Prosthodontics Research. 2017 July; 61(3): 259-67
http://www.sciencedirect.com/science/article/pii/S1883195816301074

 
Mandibular 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/21925942

 
Mandibular Advancement Device as a Comparable Treatment to Nasal Continuous Positive Airway Pressure for Positional Obstructive Sleep Apnea Yoshikazu Takaesu, PhD1; Satoru Tsuiki, PhD2,4,5; Mina Kobayashi, PhD2,4; Yoko Komada, PhD2,3,4; Hideaki Nakayama, PhD6; Yuichi Inoue, PhD 2,3,4 J Clin Sleep Med. 2016 Aug 15; 12(8): 1113-9
https://www.ncbi.nlm.nih.gov/pubmed/27250814
 
EVIDENCE FOR IMPROVED CLINICAL OUTCOMES 

Modulation 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/24634622

 
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; 187(8):879-87.
http://www.ncbi.nlm.nih.gov/pubmed/23413266

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.
http://www.ncbi.nlm.nih.gov/pubmed/15453552

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.
http://www.ncbi.nlm.nih.gov/pubmed/23731062

 
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.
http://www.ncbi.nlm.nih.gov/pubmed/22821223

 
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/25221854

 
Mandibular Advancement device & CPAP upon cardiovascular parameters in OSA 
Cibele Dal-Fabbro, Silvério Garbuio, Vânia D’Almeida, Fátima D. Cintra, Sergio Tufik, Lia Bittencourt. Sleep. 2014 January 26.
http://www.ncbi.nlm.nih.gov/pubmed/24463982
 

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/23372472
 

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.
http://www.ncbi.nlm.nih.gov/pubmed/17564405

 
Improvement 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, PhD 3,4; Zoran Dogas MD, PhD 3,4. J Clin Sleep Med. 2016 Feb;12(2):177-86.
https://www.ncbi.nlm.nih.gov/pubmed/26414974

 
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 AM, Kohler M. JAMA. 2015 Dec 1;314(21):2280-93
http://www.ncbi.nlm.nih.gov/pubmed/26624827

 
Comparison of effects of OSA treatment by MAD and by CPAP on cardiac autonomic function during daytime 
Glos M, Penzel T, Schoebel C, Nitzsche GR, Zimmermann S, Rudolph C, Blau A, Baumann G, Jost-Brinkmann PG, Rautengarten S, Meier JC, Peroz I, Fietze I. Sleep Breath. 2016 May;20(2):635-46
http://www.ncbi.nlm.nih.gov/pubmed/26463420

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