Clinical Research of the SomnoDent™ MAS
Research and clinical trials using earlier models or the current model of the SomnoDent™ MAS conducted by the Department of Respiratory and Sleep Medicine at St George Hospital, Sydney have found a high level of acceptance and tolerance amongst patients and concluded that the SomnoDent™ MAS is a viable alternative to CPAP in the treatment of OSA in a significant proportion of patients across all grades of OSA severity1, 2.
The results included both subjective and objective measurements of the efficacy of the SomnoDent™ MAS in treating OSA and snoring, and the key results were as follows:
Summary of Results for Treatment of OSA
- Using a rigorous definition of complete response (AHI<5/hour) and partial response (greater than 50% reduction in AHI), the SomnoDent™ MAS was shown to treat OSA (completely or partially) in 63% of patients across all grades of severity;
- Using the more liberal success criterion common to most other studies (AHI <10/hour), the SomnoDent™ MAS achieved success in 71% of patients1;
- The SomnoDent™ MAS resulted in an improvement in sleep quality, with patients experiencing an increase in Rapid Eye Movement sleep1; and
- the SomnoDent™ MAS treatment significantly improved blood oxygenation levels and reduced the number of arousals during sleep1, 2.
- The majority of patients reported significant subjective improvements, with 83% of patients reporting combined improvements in snoring, sleep quality and daytime sleepiness1.
- Compliance: 86% of patients reported nightly use of the SomnoDent™ MAS1.
- Acceptance: Over 95% of patients stated that they would like to continue using SomnoDent™ MAS, because of perceived benefits1, 2.
Summary of Results for Treatment of Snoring
- The SomnoDent™ MAS achieved a significant reduction in ‘mean snoring frequency’, reducing the number of snores per hour by 43%.2
- The SomnoDent™ MAS achieved a significant reduction in both the mean snoring intensity and the maximum snoring intensity by 3 decibels2.
(The results for Snoring regarding the effectiveness, Compliance and Acceptance of the MAS are the same as for OSA and are set out above.)
Expert Acknowledgement of Research Results
Both these studies were published in the American Journal of Respiratory and Critical Care Medicine, a prestigious international respiratory journal. The paper by Mehta et al was acknowledged in an editorial in that journal entitled 'Oral Appliance Therapy for (OSA): Finally Evidence You Can Sink Your Teeth Into' as a 'major step forward' and &'confirmation of the efficacy of [MAS] therapy in some patients with OSA3.'
- Mehta A, et al: A Randomized, Controlled Study of a Mandibular Advancement Splint for Obstructive Sleep Apnea. Am J Respir Crit Care Med 2001; 163: 1457-1461;
- Gotsopoulos H, et al: Oral Appliance Therapy Improves Symptoms in Obstructive Sleep Apnea. A Randomized, Controlled Trial. Am J Respir Crit Care Med 2002; 166: 743-748;
- Ferguson KA: Oral Appliance Therapy for Obstructive Sleep Apnea. Finally Evidence You Can Sink Your Teeth Into. Am J Respir Crit Care Med 2001; 63:1294-5.
The following charts summarise the key objective and subjective results of the research.
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