People across Canada and the United States rely on medical devices to maintain and improve their health and well-being. Each country has stringent requirements for medical devices in order to meet the standards they have established in their respective regulatory systems— which are among the best in the world. Dental sleep medicine research and clinical trials support the validity and clearance of medical devices.
Zephyr’s MATRx plus™ is classified as a medical device and was cleared for use by both Health Canada and the US Food and Drug Administration (FDA).
In the US, the MATRx plus was considered a new class of device – no predicate existed. As a consequence, Zephyr submitted a “De Novo” application.
There is nothing else like the MATRx plus and some may even call it “disruptive” or “breakthrough”. This is because it is the only medical device that dental professionals can use to accurately and efficiently test and fit an oral appliance to treat obstructive sleep apnea.
The product’s predictive algorithms select patients who will be effectively treated with an oral sleep appliance, also known as oral appliance therapy.
In order to bring this product to market, years of dental sleep medicine research and clinical trials have been undertaken to meet the standards set by both Health Canada and the FDA. Zephyr continues to undertake regular clinical trials to test new functionalities and technologies that may further advance the treatment of obstructive sleep apnea.
To find out more about some of the dental sleep medicine research and the clinical validation of Zephyr’s products, please take a look at the abstracts referenced below.
MATRx plus (Feedback Controlled Mandibular Positioner)
A feedback-controlled mandibular positioner identifies individuals with sleep apnea who will respond to oral appliance therapy. Remmers JE, Topor Z, Grosse J, Vranjes N, Mosca EV, Brant R, Bruehlmann S, Charkhandeh S, Jahromi SA. J Clin Sleep Med 2017; 13(7): 871–880. View publication
A mandibular positioning home sleep test prospectively predicts outcome of oral appliance therapy for OSA using retrospectively derived decision criteria. Remmers, J.E., Zareian A., Topor Z., Grosse J., Vranjes N., Charkhandeh S. In Proceedings at the 25th Annual Meeting of the AADSM (Poster Board #015). Denver, CO. June 9-11, 2016. View poster
Prediction of outcome with oral appliance therapy for obstructive sleep apnea using in-home mandibular titration. Remmers, J.E., Zareian A., Topor Z., Grosse J., Vranjes N., Charkhandeh S. In Proceedings at ATS 2016 International Conference (Poster details: A7467; Poster Board P1089). San Francisco, CA. May 13-18, 2016. View poster
An auto-titrating mandibular positioner: accuracy in predicting oral appliance therapy and efficacious mandibular protrusion. Charkhandeh S., Topor Z., Grosse J., Vranjes N., Zareian S.A., D’Andrea J., Bruehlmann S., Remmers J.E. In Proceedings at the 24th Annual Meeting of the AADSM and SLEEP 2015 (Abstract ID#17: AADSM Poster Board #017; APSS Poster Board #363). Seattle, WA. June 4-10, 2015. View poster | View abstract
Predicting oral appliance therapy outcome using an auto-adjusting mandibular positioner in the home. Topor Z., Grosse J., Zareian Jahromi S.A., D’Andrea J., Bruehlmann S., Charkhandeh S., Remmers J.E. In Proceedings at the 2015 ATS Conference (Abstract ID #62764). Denver, CO. May 15-20, 2015. View abstract
Oral Appliance Therapy: Clinical Evidence
Validation of a New Unattended Sleep Apnea Monitor using Two Methods for the Identification of Hypopneas. Topor, ZL, Remmers, JE, Grosse, J, Mosca, EV, Jahromi, SZ, Zhu, Y, Bruehlmann, S. Journal of Clinical Sleep Medicine 2020; 16(5): 695-703. View publication
Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: An update for 2015. Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. J Clin Sleep Med 2015; 11(7): 773–827. View publication
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. View publication
Oral Appliance Therapy: Clinical Efficacy/Preference
A fully digital workflow and device manufacturing for mandibular repositioning devices for the treatment of obstructive sleep apnea: A feasibility study. Charkhandeh S, Kuhns D, Kim S. Journal of Dental Sleep Medicine. 2017; 4(4): 97–102. View publication
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. View publication
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. View publication
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. View publication
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. View publication
Mandibular advancement splint as short-term alternative treatment in patients 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. View publication
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. View publication
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. View publication
Long-term compliance and side effects of oral appliances used for the treatment of snoring and obstructive sleep apnea syndrome. 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. View publication
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. View publication
Oral Appliance Therapy: 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. View publication
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. View publication
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. View publication
The link between sleep bruxism, sleep disordered breathing and temporomandibular disorders: An evidence-based review. Balasubramaniam R, Klasser GD, Cistulli PA, Lavigne GJ. Journal of Dental Sleep Medicine 2014;1(1):27–37. View publication
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. View publication
Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: A randomized controlled trial.Phillips CL, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, Marks GB, Cistulli PA. Am J Respir Crit Care Med 2013; 187(8): 879-887. View publication
Continuous positive airway pressure versus the mandibular advancing splint: Are they equally effective in obstructive sleep apnea management?White DP. Am J Respir Crit Care Med 2013 Editorial; 187:795-797. View publication
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. View publication
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. View publication
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. View publication
New Technology: Clinical Evidence
Non-invasive identification of inspiratory flow limitation in patients sleeping with an oral appliance in place.S.A. Zareian Jahromi, PhD, J. Grosse, MMath, Z.L. Topor, PhD, J. Sun, PhD, Q. Sun PhD, J.E. Remmers, PhD. In Proceedings at ATS 2014 (Poster Presentation, Poster Board #H70; Publication Number: A3599). San Diego, California, May 16-21, 2014. View poster | View abstract
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. View publication
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 et al. Thorax 2013; 68:91-96. View publication
Drug-induced sleep endoscopy completed with a simulation bit approach for the prediction of the outcome of treatment of obstructive sleep apnea with mandibular repositioning appliances.Vanderveken OM, Vroegop AV, MD, Van de Heyning PH, Braem MJ. Operative Techniques in Otolaryngology 2011; 22(2): 175-182. View publication
MATRx(Remote Controlled Mandibular Positioner)
Performance of remotely controlled mandibular protrusion sleep studies for prediction of oral appliance treatment response.Sutherland K, Ngiam J, Cistulli PA. J Clin Sleep Med 2017; 13(3): 411-417. View publication
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 the mandible: A systemic review.Kastoer C, Dieltjens M, Oorts E, Hamans E, Braem MJ, Van de Heyning PH, Vanderveken OM. J Clin Sleep Med 2016; 12(10): 1411-1421. View publication
Mandibular advancement device titration using a remote controlled mandibular positioner.Omar E. Burschtin MD, David S. Binder DDS, Jason Lim BA, Samantha Marsiliani RDH, Indu Ayappa PhD, David M. Rapoport MD. In Proceedings at the 2014 SLEEP (Poster Presentation, Poster Board #252; Publication Page 168, #0426). Minnesota, Minneapolis, June 1-4, 2014. View poster
Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea.Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. SLEEP 2013; 36(10): 1517-1525. View publication
Selecting OSA patients for oral appliance therapy by mandibular protrusive titration: effect of hypopnea scoring criteria on predictive accuracy.Remmers J, Charkhandeh S, Topor Z, Grosse J, Santosham P, Bruehlmann S. In Proceedings at the 2012 SLEEP Conference (Poster Presentation, Poster Board #193; Publication Page A195, #0576). Boston, Massachusetts, June 9-13, 2012. View abstract
Target protrusive position from mandibular protrusion titration: is it a good estimate of adequate protrusion? Does it Correlate with RDI or BMI?Charkhandeh S, Topor ZL, Grosse JC, Santosham P, Bruehlmann S and Remmers JE. In Proceedings at the 21st Annual Meeting of the AADSM at the SLEEP 2012 Conference (Poster Presentation & Podium, Poster Board #001; Publication Page 29). Boston, Massachusetts, June 7-9, 2012. View abstract
Mandibular protrusion during sleep predicts outcome with oral appliance therapy of sleep apnea.Remmers J, Charkhandeh S, Topor Z, Grosse J, Bruehlmann S. In Proceedings at the ATS 2012 International Conference (Poster Presentation, Poster Board #616; Publication Page A3855). San Francisco, California, May 18-23, 2012. View abstract
Selection of obstructive sleep apnea patients for oral appliance therapy.Remmers J. In Proceedings of the World Sleep 2011 Conference (Invited Lecturer). Kyoto, Japan, October 16-20, 2011.Selection of patients for oral appliance therapy using mandibular protrusion during sleep.Charkhandeh S, Topor Z, Grosse J, Turner M, Remmers J. In Proceedings at the 2011 SLEEP Conference (Publication Page A117, #0331). Minneapolis, Minnesota, June 12-15, 2011. View abstract
Mandibular advancement and obstructive sleep apnea: a method for determining effective mandibular protrusion.Dort LC, Hadjuk E, Remmers JE. Eur Respir J 2006; 27(5):1003-9. View publication
Remotely controlled mandibular positioner predicts efficacy of oral appliances in sleep apnea.Tsai WH, Vazquez J, Oshima T, Dort LC, Roycroft B, Lowe A, Hadjuk E, Remmers JE, Am J Respir Crit Care Med 2004; 170(4): 366-70. View publication