Stop snoring with the SomnoGuard®
Mandibular Advancement Anti-Snoring Appliances
"A mandibular advancement device for the ENT office to treat obstructive sleep apnea"
Maurer JT, Huber K, Verse T, Hormann K, Stuck B
Sleep Disorders Center, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Germany
Published in: Otolaryngol Head Neck Surg., 2007, 136: 231 - 235
Objective
To prospectively evaluate the efficacy of the mandibular advancement device (MAD) Somnoguard in the treatment of OSA patients.
Study Design and Setting
Forty-four patients with OSA and noncompliant to continuous positive airway pressure were enrolled in this case series. Somnoguard is made of thermoplastic material. Direct intraoral fitting was done by an otorhinolaryngologist. Polysomnographic data concerning sleep and respiration were assessed at baseline and after familiarization with the MAD.
Results
Sleep efficiency and sleep stages distribution did not change significantly. The RDI could be reduced from 31.5+/-17.6 to 18.2+/-17.0 (P<0.05), the minimal oxygen saturation increased from 78+/-12.9 to 82+/-12.5% (P<0.05). According to standard criteria, 18 patients were cured, 12 were improved, 8 remained unchanged, and 6 worsened. Snoring time decreased from 223+/-132 to 183+/-134 minutes (P<0.05).
Conclusion and Significance
With Somnoguard 68% of the enrolled OSA patients could be cured or substantially improved. It is a simple MAD for the otolaryngologist
"A Pilot Study of a Novel Mandibular Advancement Device for the Control of Snoring"
O.M. Vanderveken¹ ³, A.N. Boudewyns¹, M.J. Braem², W. Okkerse², J. A. Verbraecken³, M. Willemen³, F.L. Wutys¹ °, W. A. de Backer³ and P.H. van de Heyning¹
Departments of ¹Otorhinolaryngology, Head and Neck Surgery, ²Dentistry, ³Pulmonary Medicine, and °Biomedical Physics, University Hospital, University of Antwerp, Antwerp, Belgium
Published in: Acta Otolaryngol, 2004, 124: 628-633
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.
Original publication abstract
Lecture from Dr. O.M. Vanderveken 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 Heyning
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 &mt; 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.
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