Reproduced by kind permission of Tomed Dr. Toussaint GmbH
Based on several years of clinical research we developed SomnoGuard® in cooperation with the ENT university hospitals of Mannheim/Germany and Antwerp/Belgium.
In comparison with other devices, SomnoGuard® features improved jaw impression into the copolymeric material, less side effects and a significant extension of the life cycle by implementing a new geometrical design and changing the chemical composition of the copolymers applied in the manufacturing process. To increase safety the SomnoGuard® mouthpiece contains a hole for emergency breathing. Contrary to the other devices with an average life span of only approximately 4 months (when the appliance is bitten through and has to be replaced by a new one), the average life cycle of SomnoGuard is approximately one year or even longer according to clinical experience with both appliances. It goes without saying that the extended life span has reduced annual costs of using SomnoGuard considerably compared with the formerly marketed appliance.
Lecture of O.M. Vanderveken, Ph.D.,M.D., at the ENT-university clinic of Brussels on 23.02.2002
"A pilot study of a novel mandibular advancement device for the control of snoring"
O.M. Vanderveken¹, ³, A. Boudewyns¹, M.J. Braem², W. Okkerse², J. A. Verbraecken³, M. Willemen³,
F.L. Wutys¹, º, W. A. de Backer³ and P.H. van de Heyning¹
Departments of ¹Otorhinolaryngology, Head and Neck Surgery, ²Dentistry, ³Pulmonary Medicine, and ºBiomedical Physics, University Hospital, University of Antwerp, Antwerp, Belgium
Accepted for publication in: Acta Oto-Laryngologica, Stockholm (Date of information: 04.09.2003)
Objective
Prospective, non-randomised evaluation of the efficacy, side effects and compliance of the new mandibular advancement device SomnoGuard in subjects suffering from primary snoring and/or mild obstructive sleep apnea.
Methods
20 patients aged 26 to 72 (on average 46 years, BMI 26.72 + 3.48 kg/m2) with a respiratory disturbance index (RDI) < 20 took part in this pilot study. Before fitting the device an ambulatory polysomnograhy and a full dental examination was performed routinely to identify dental or temporo mandibular joint (TMJ) complications . Patients with any pre-existent TMJ dysfunction or having not enough natural teeth to anchor the device were excluded from study enrollment. After these initial medical examinations the device was fitted to the patients and a one-month-habituation period followed. Immediately thereafter and again six months after fitting SomnoGuard® patients underwent another polysomnography with the appliance worn when sleeping and a dental examination for therapy control. Snoring and excessive daytime sleepiness were evaluated by using a subjective 10 cm visual analogue (VAS) scale and the Epworth sleepiness scale by the sleeping partners. Treatment success was defined as a reduction of the initial RDI value by at least 50%.
Results
Treatment success rate according to the aforementioned definition was 65%. RDI values decreased significantly from initially 8.4 + 2.9/h to 3.9 + 1.8 (p=0.001). In addition, VAS- (p< 0.001) and ESS-scores (P=0.036) decreased significantly at the. 1-month control examination. Similar results were observed at the 6-month-control visit, with again significant reductions of the VAS- (p=0.025) and ESS-scores (P=0.033). Tolerabilty of the device was considered as quite good by the participants of the study. Inititial hypersalivation and temporary jaw muscle discomfort disappeared when getting accustomed to the device with time (cf. to the lecture chart, please klick). Compliance after 4 weeks of appliance therapy was 80%, however decreased towards the end of the 6-month observation period. After all compliance was assessed as rather high by the investigators.
Assessment
SomnoGuard® is able to reduce successfully the respiratory disturbance index, snoring and excessive daytime sleepiness occuring in general with the obstructive sleep apnoea syndrome (OSAS) as had been shown in a 6-months' pilot study. Investigators conclude that further clinical trials should be performed to investigate the full sleep medical potential of the appliance, i.e. SomnoGuard® should be compared preferably in a cross-over designed study against a custom-made dental appliance to find out definitely whether it can be used for screening candidates for much more expensive in a dental laboratory custom-made mandibular advancement devices.
Lecture from O.M. Vanderveken, Ph.D., M.D., presented on the "7th World Congress on Sleep Apnea" in Helsinki on 2 July 2003
"Subjective Assessment of a one-piece mandibular advancement device
out of thermoplastic material on snoring and daytime sleepiness"
O.M. Vanderveken¹, ³, A. Boudewyns¹, M.J. Braem², M. Willemen³, W. Okkerse², J. A. Verbraecken³,
E. Hamans¹, W. A. de Backer³ and P.H. van de Heyning¹
Departments of ¹Otorhinolaryngology, Head and Neck Surgery, ²Dentistry, ³Pulmonary Medicine,
University Hospital, University of Antwerp, Antwerp, Belgium
Publication under preparation
Objective
Subjective evaluation of SomnoGuard® to control snoring and excessive daytime sleepiness (EDS)
Methods 36 heavy snorers (47.1 + 11.6 years old, BMI 25.9 + 3.4 kg/m2) with RDI < 20 values were enrolled. The Epworth Sleepiness Scale (ESS) with score values from 0 to 24 was used to evaluate excessive daytime sleepiness. EDS is defined as ESS-Score > 10. The Visual Analogue Scale (VAS) with score values from 0 (no snoring) to 10 (extreme heavy snoring, bed partner leaves room) was used to evaluate snoring during sleep by the bed partner. Heavy snoring is commonly defined as VAS-Score > 7. Clinical examination was performed intially prior to fitting the device, then thereafter at 1-month- and 6-months' intervals for therapy control. Those subjects were considered responders who still used the oral appliance at the rather end point of the study, i.e. after "0.8 + 0.4 years" resp. 5 to 14months after initial fitting of the device. In addition, VAS-Score < 3 was required, or adequately sounds of snoring should no more be hearable.
Results
Nine out of 36 patients complained about excessive daytime sleepiness at the rather beginning of the study without oral appliance. EDS had disappeared with 6 from those 9 subjects (67%) at the study end point, i.e. ESS score was < 10. The average ESS-Score was 4.2 at the 6-month control. At he end point follow-up, i.e. after 5 to 14 months, responder rate was 56%. Thereby, baseline VAS score decreased from 9.0 + 0.2 to 4.1 + 0.6 at the 1-month control and to 4.2 + 0.6 at the 6-months follow-up control visits.
Assessment
The presented study demonstrates that by using VAS and ESS scoring methods, being accessible to every doctor's office in daily practice, SomnoGuard® is able to reduce heavy snoring and excessive daytime sleepiness in patients suffering from mild obstructive sleep apnoea. The authors consider treatment of heavy snoring and excessive daytime sleepiness as a cost-effective and valuable therapeutic option and finally recommend future studies to compare custom-made and the SomnoGuard® thermoplastic mandibular advancement devices.
Perspectives
Tomed is ambitious to continue to develop the currently marketed commercial SomnoGuard®. Therefore, we are performing with our follow-up development product named SomnoGuard® Plus a randomised polysomnography controlled cross-over study against a dental lab custom-made oral appliance in patients suffering from moderate obstructive sleep apnoea (i.e. RDI < 40/h). A total of 80 patients will equally be enrolled in 2 study groups (2x 40). We will report about the results later in due time under this section.
We anticipate according to our current knowledge that we will market probably as of mid 2004 both SomnoGuard® and SomnoGuard® Plus. From today's point of view current commercial SomnoGuard® appears to be the ideal appliance for medium and small sized jaws without any dental bite and tooth position abnormalities. On the other hand side, SomnoGuard® Plus appears to be the appliance of choice for patients with a deep bite, large sized jaws and beyond average long front teeth.
Reproduced by kind permission of Tomed Dr. Toussaint GmbH
