SomnoGuard®AP
Two-part infinitely adjustable prefabricated "boil & bite" mandibularadvancement device
Our No. 1 bestseller in many countries. Made in Germany by Tomed.
Clinical Trials
You will find thereafter an actual update on the outcome of clinical trials which had been performed so far with the SomnoGuard AP and brought to attendance on this website. It is worth mentioning that we had reduced the front width of the lower jaw tray by nearly 50% during the first half of 2009 to optimise comfort of use (please rf. to the fig. thereafter).
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Thereafter, the trial mentioned here is considered the worldwides largest trial according to our knowledge which had been performed so far with prefabricated mandibular advancement devices. It compares for the very first time a relatively cheap infinitely adjustable thermoplastic (i.e. according to the lecture SomnoGuard AP) with a comparable many times more expensive custom made oral appliance (i.e. TAP 3). Publication is expected in 2012. Both trials described thereafter had been performed with the actual modern slimline version. |
 Lower jaw tray - former original and actual slimline version (available as of June 2009) |
Friedman M, Maley A, Taylor D, Lelley K, Pearson-Chauhan
Dep. of Otolaryngology at Rush University Medical Center, Chicago / U.S.A.
Lecture abstract published in: Otolaryngol Head Neck Surgery, 2011, 145-supplement: 134; lectured at the AAO-HNSF Annual Meeting & OTO EXPO in San Francisco on 12 September 2011
Objectives
1) Report our experience with custom-made (i.e. TAP 3) and
thermoplastic (i.e. SomnoGuard AP) mandibular advancement devices
(MADs). 2) Compare the cost, efficacy, and compliance of thermoplastic
mandibular advancement devices vs custom made MADs.
Methods
Retrospective review of 287 consecutive adult outpatients treated
between July 2009 and August 2010. Compliance was assessed
using chart review and phone interviews after 1 and
6 months. Endpoints included: 1. Efficacy measured by post-MAD AHI.
Results
The percentage of patients achieving AHI reduction criteria for
efficacy was 70.3% and 72.2% for thermoplastic (i.e. SomnoGuard AP) vs
custom-made (i.e. TAP 3) devices (P = .204). Compliance more than 4 hours a night for 70% of nights within the first month after receiving MAD was 88.2% for
thermoplastic vs 64.3% for custom-made (P < .001). At 6 months compliance was 47.4% for thermoplastic devices vs 61.1% for custom devices (P = .01). The average cost for the thermoplastic devices was $150 vs $1450 for the custom-made devices.
Based on subjective analysis at two months' follow-up the average overall success -referring to all patients enrolled in this study- was 38.6 percent. An explanation of this relatively low value is that that patients who met the minimum two-month follow-up for the subjective analysis had been lost to further follow-up (n = 8), declined to respond to questionnaires (n = 3), used the devices less than 5 nights per week (n= 9), missed final PSG control (n = 10), no longer used their oral device chosen at the beginning of treatment (n = 25) or had finally failed the OR criterion (n = 16). Specific overall success data referring to the three different individual oral appliances which had been compared in this study is not known.
Conclusions
Thermoplastic devices (i.e. SomnoGuard AP) resulted in slightly better compliance rate
compared with the custom-made devices (i.e. TAP 3) during the first
month after prescription, but reversed at 6 months.
Thermoplastic devices have the advantage of significantly lower cost,
higher initial acceptance, and comparable efficacy,
whereas custom-made devices result in higher long-term compliance.
Friedman M, Pulver T, Wilson MN, Golbin D, Leesman C, Lee G and Joseph NJ
Dep. of Otolaryngology at Rush University Medical Center, Chicago / U.S.A.
Published in: Otolaryngol Head Neck Surgery, 2010, 143: 78 - 85
Objectives
1) Treating patients with obstructive sleep
apnea-hypopnea syndrome (OSAHS) with titratable and non-titratable
thermoplastic mandibular advancement devices (MADs) fitted in an
otolaryngology clinic. 2) Compare these devices in terms of objective
response (OR), as defined by a > 50
percent decrease in baseline apnea-hypopnea index (AHI) and an AHI <
20, and subjective parameters, including adherence. 3) Determine
overall success, calculated as number of patients with OR using the
device five or more nights a week divided by the total number of
patients who completed both the follow-up polysomnography (PSG) and
questionnaires at two months follow-up.
Methods
A prospective, non-randomized cohort study in a
tertiary
care center. Patients with OSAHS who tried and failed or refused
both continuous positive airway pressure (CPAP) and surgical therapy
were fitted -often under financial considerations- with a non-titratable
Snore Guard (n = 38), non-titratable SomnoGuard 2.0 (n = 8), or
titratable SomnoGuard AP (n = 41). Pre- and post-treatment assessment
included: 1) Epworth Sleepiness Scale, 2) snoring level rated on a
visual analogue scale (VAS) by the bed partner, 3) polysomnogram,
4) two months follow-up control to assess adherence and subjective
parameters.
Results
OR was achieved in 62.1 percent of patients overall.
Thereby, OR was each with SomnoGuard AP 65.9%, SomnoGuard 2.0
62.5% and Snore Guard 57.9%. Overall mean reduction in AHI
was from 39.96 +/- 23.70 to 14.86 +/- 13.46 (P = 0.000). Adherence at
two months was 58.5 percent. No significant differences were observed
in OR or adherence according to MAD type, though improvements in AHI
and minimum oxygen saturation were significantly better for the
SomnoGuard AP than for the non-titratable devices. Regarding SomnoGuard
AP mean AHI without MAD decreased from
45.09 +/- 21.99 to 12.75 +/- 13.23 with MAD (P = 0.000), whereas mean
AHI for the
SomnoGuard 2.0 dropped from 26.65 +/- 12.02 to 13.09 +/- 12.21 (P =
0.084) and for Snore Guard from 37.23 +/- 26.07 to 17.51 +/- 13.80 (P =
0.000). Mean minimum SpO2 increased
with SomnoGuard AP from 81.07 +/- 7.66 to 90.50 +/- 5.14 (P =
0.000), with SomnoGuard 2.0 from 86.46 +/- 5.98 to 89.00 +/- 3.46 (P =
0.381) and for the Snore Guard from 84.77 +/- 6.87 to 86.73 +/- 4.89 (P
= 0.092). ESS and VAS scores dropped significantly under
treatment with any oral device. It is worth mentioning that 78% of all patients treated with
SomnoGuard AP suffered from severe obstructive sleep apnea defined as
AHI > 30 and 70.7% of these patients had underwent surgery without
success before the onset of oral appliance treatment.
Based on subjective analysis at two months' follow-up the average overall success -referring to all patients enrolled in this study- was 38.6 percent. An explanation of this relatively low value is that that patients who met the minimum two-month follow-up for the subjective analysis had been lost to further follow-up (n = 8), declined to respond to questionnaires (n = 3), used the devices less than 5 nights per week (n= 9), missed final PSG control (n = 10), no longer used their oral device chosen at the beginning of treatment (n = 25) or had finally failed the OR criterion (n = 16). Specific overall success data referring to the three different individual oral appliances which had been compared in this study is not known.
Conclusions
Treatment outcome with SomnoGuard AP regarding
the AHI reduction and improving the blood oxygen saturation (SpO2)
was significantly better compared to the devices
SomnoGuard 2.0 and Snore Guard. The OR of this study compares favorably with other
publications referring mainly to custom-made appliances1,2. Notably, patients with severe OSAHS achieved even a higher raste of OR than patients in other studies.
Thermoplastic MADs are a relatively inexpensive treatment alternative for patients with OSAHS who fail/refuse CPAP and upper airway surgery. They can be easily fitted in the otolaryngology clinic. Long-term compliance, efficacy, and safety are unknown at this time.
References: 1) Kushida CA, Morgenthaler TI, Littner MR, et al. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral, appliances: an update for 2005. Sleep 2006;29:240 –3, 2) Lim J, Lasserson TJ, Fleetham J, et al. Oral appliances for obstructive sleep apnea (review). Cochrane Library 2008;4:1– 46.
Original publication