Clinical Trials
Based on several years of clinical research and daily practice experience with the formerly marketed SnorBan we developed SomnoGuard in cooperation with the ENT university hospitals of Mannheim/Germany and Antwerp/Belgium.
Present clinical outcome data referring to efficacy are equivalent from a subjective and objective point of view to those generated with the predecessor SnorBan (see abstract below). However, in comparison with the predecessor 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 pedecessor Snorban with an average life span of only approximately 4 months (then 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.
Thereafter, there is a survey on clinical trials with SomnoGuard both completed or still running as well as those performed earlier by Tomed with the SnorBan appliance:
"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 > 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.
Previous and already published clinical studies with the predecessor SnorBan
"Immediate Intraoral Adaptation of Mandibular Advancing Appliances of Thermoplastic Material for the Treatment of Obstructive Sleep Apnea"
B. Schoenhofer¹, W. Hochbahn², H.J. Vieregge¹, H. Brünig¹, D. Köhler¹ (¹Krankenhaus Kloster Grafschaft, Schmallenberg-Grafschaft, Ber. Pneumologie und Schlafmedizin, ²Univ.- Zahnklinik Marburg)
Published in: Respiration, 2000, 67: 83 – 88 |
Background:
In the treatment of obstructive sleep apnea (OSA), mandibular advancing devices (MAD) are usually individually fabricated on plaster casts of both jaws from polymethyl-methacrylate. The potential disadvantages of these devices are (1) the costs and (2) the time required to construct the device.
Objective:
In this study, the efficacy and feasibility of a cheap MAD consisting of thermoplastic material (SnorBanTM), which can be directly moulded intraorally, were evaluated.
Methods:
In a prospective study, the effect of a MAD consisting of thermoplastic material was investigated in 22 consecutive patients with OSA ((respiratory disturbance index (RDI) 32.6 ± 18.4/h)). Polysomnographic sleep was recorded prior to treatment and after 3 months of treatment with the MAD.
Results:
Three of the 22 patients who did not tolerate the MAD were excluded from the analysis, whereas 11 patients were classified as responders. In the responder group, the mean RDI decreased from 27.6 ± 7.3 to 7.3 ± 2.9 (p < 0.01), correspondingly the sleep quality and the Epworth Sleepiness Scale improved (p < 0.05). Eight patients proved to be non-responders without relevant changes for the measured parameters.
Conclusions:
In 50% (11 of 22) of the patients, the MAD improved the OSA to a clinically relevant degree. In contrast to the majority of established MAD, the MAD investigated is cheap and immediately adaptable and thus a feasible strategy to “screen” the efficacy of this therapeutic principle. Thus the construction of unnecessary MAD is avoided.
The use of an oral mandibular advancement device out of thermoflexible vinyl in connection with sleep related breathing disturbances.
J.T. Maurer, K. Hirth, C. Mattinger, F. Riedel, B. Werner, K. Hörmann
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde, Mannheim (Direktor: Prof. K. Hörmann)
Published in: HNO, 2000, 48:302 – 308 |
Objectives
In an open study design the following objectives in patients suffering from snoring with and without sleep-related respiration disturbances were to be investigated using the thermoflixible mamdibular advancement device SnorBan:
- the influence on the duration and intensity of snoring,
- the frequency of apnea and hypopnea during sleep,
- the oxygen content in the blood to examine the sleep structure and finally the
- daytime sleepiness/fatigue.
Inclusion criteria
- nocturnal snoring
- proper nose respiration
- complete tooth status
Exclusion criteria
- gulping when pressing with the spatula on the rear two thirds of the tongue
- gulping when brushing teeth
- progenia
- extreme dysgnathia that makes fitting impossible
Methods
After complete polysomnography medical personnel fitted the mouthpiece in those patients, who had met the inclusion criteria and had given informed consent to participate in the clinical study. After fitting, the correct tightness and the form of the prosthesis were controlled. After a period of 4 weeks on average patients were accustomed to the mouthpiece and subsequently underwent follow-up polysomnography, clinical examination and were interviewed about symptoms, treatment effectiveness, side effects and satisfaction with their mouthpiece.
Out of 53 patients who were consecutively selected 5 rejected study enrollment, and 7 patients were excluded for dental reasons. Altogether, 41 patients were supplied with SnorBan, whereby 39 appeared for re-examination and thus composing the evaluable group which consisted of 33 men and 6 women with an average age of 51.1 + / - 9.2 years.
Results
All patients confirmed having had no problems with the oral mandibular advancement device. A total of 79.5% confirmed that they were very satisfied (23.1%) or satisfied with regard to comfort during everyday use and effectiveness, only 20.5% were dissatisfied. When using SnorBan, 45.9% of all patients reported improved general health, only 7.7% reported a general impairment.
Increased salivation was reported by 22 patients. Transient toothache in the morning was reported by 17 patients, jaw joint pain by 7 and nausea by 3 patients. Deformations while using the mandibular advancement device had not been reported. The average period of time for getting accustomed to the mouthpiece was between 0 to 21 days (average: 4 days).
Furthermore, 43.6% of patients reported a significant and still 33.3% a moderate reduction of the intensity of snoring and its duration while using SnorBan. With reagard to sleep apnea patients, it was found that nocturnal respiratory arrests had decreased considerably in all cases (average AHI reduction of about 51%).
Polysomnography revealed an average reduction of the total snoring period by 59.5% on average. With regard to patients with an initial AHI exceeding 10/h, this value decreased by an average of 50 to 80% while using SnorBan. Even a reduction of initially high AHI values to below 10/h had been demonstrated, e.g. from initially 56.5 to 3.8. In one case, there was an increase of the AHI value from initially 6.5/h to 25.6/h. Overall compliance was 75%. However, under consideration of the 7 patients excluded from study participation for dental reasons, only 64.6% of all patients who wanted to take part in the study actually made use of the aplliance.
Assessment
Neither severe side effects nor health endangering complications had been reported while using SnorBan in the course of the one month clinical trial.
Currently available subjective and objective outcome parameters are interpreted as promising hints for the use of SnorBan not only in habitual snoring, but also in obstructive sleep apnoea.
The use of SnorBan is medically recommended for appropriate indications. In- and exclusion criteria must be considered.
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