Publicerat med tillstånd av Tomed Medical GMBH, Tyskland

 

Clinical Trials

Study 1: Lecture Summary

 

The use of an oral mandibular advancement device

out of thermoflexible vinyl in connection with

sleep related breathing disturbances.

J.T. Maurer, B. Werner, C. Juncker, F. Riedel, K. Hörmann
(all: Univ. - ENT Clinic, Mannheim, Sleep Medicine Center)

Total study published in the journal:

 HNO
of Springer Publishers
(Berlin, Heidelberg), vol. 48, in April 2000.

1. Trial 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 oral mandibular device ãSnorBan^TM":

- 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.

The oral mandibular advancement device consists of a thermoflexible material that is fitted to the patient after heating up in hot water and used during the night.

2. Inclusion criteria 
- nocturnal snoring
- proper nose respiration 
- complete tooth status

3. 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

4. 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 to 8 weeks 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.

5. Study population
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.

6. 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 ireported 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%.

7. Assessment
Neither severe side effects nor health endangering complications had been reported while using SnorBan. 

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 apnea.

The use of SnorBan is medically recommended for the appropriate indications.  In- and exclusion criteria must be considered.
 
 

Clinical Trials:

Study 2:  Publication Abstract

"Immediate Intraoral Adaptation of Mandibular Advancing Appliances 
of Thermoplastic Material for the Treatment of Obstructive Sleep Apnea"

A. Schoenhofer ^(a), W. Hochbahn ^(b), H.J. Vieregge ^(a), H. Brünig (^a), D. Köhler^a (a)

(^{a) =} Krankenhaus Kloster Grafschaft, Schmallenberg-Grafschaft, Ber. Pneumologie und Schlafmedizin, 

^{(b) =} Univ- Zahnklinik Marburg)

 

Published in the medical journal:

:
Respiration (Karger-Publishers AG, Basel) 2000; 67: 83 Ð 88

 

1. 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. 

2. Objective:
In this study, the efficacy and feasibility of a cheap MAD consisting of thermoplastic material (SnorBan^TM), which can be directly moulded intraorally, were evaluated. 

3. 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. 

4. 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. 

5. 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 ÒscreenÓ the efficacy of this therapeutic principle. Thus the construction of unnecessary MAD is avoided.

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