Obstructive Sleep Apnea and Snoring

A New Treatment Approach
D.D.S., Ph.D., Natashia Ingemarsson-Matzen

English summary

Study of objects with obstructive sleep apnea syndrome (OSAS) and/or severe snoring, treated with a new anti-snoring device called the Noiselezz.

The new technique consists of a double ringlike structure of soft plastic material. When closed together in the mouth, the lower jaw is pulled forward in relation to the maxilla, thereby creating enough space in the pharynx to quit the obstruction.
Use of this new device has changed the life for the majority of the patients; thus increasing the working capabilities, social accommodation and sexual spirit/force.

X-ray cephalometric studies of the subjects with identical headposture, both with and without the mouthpiece in situ, showed increase in the free airway space in the pharynx.
Obstructive Sleep Apnoea Syndrome (OSAS), Snoring, Plastic material, Noiselezz Cephalometrics, Pharynx.

Background

Obstructive sleep apnoea is a severe problem for the people concerned. Annoying noise, daytime sleepiness, poor quality of sleep, morning headache, choking fits, decrease in the sexual appetite, and drowsiness are some of the problems which they face all to frequently (from 30 – 95%), (1, 2, 3, 4.) and their families often experience disturbances in their otherwise normal sleeping rhythm.

Due to the above mentioned problems many of these patients are unable to concentrate and they are unable to stay alert. This might among other things cause an over frequency in work related accidents: Survey material from Israel relates 52% of the work related accidents to persons with apnoea conditions, and in a survey from Virginia (USA) a 7 times higher risc for traffic-related accidents could be noted in the group of patients compared to persons without the apnoea condition (7).
Further, Wiemann et al (8) have conducted surveys of survival rates with or without treatment with nCPAP equipment of persons who suffer from the sleep apnoea syndrome, and shown an excess mortality of 35% within a decade in the group that was not receiving treatment!

The assumption “once a snorer – always a snorer” compared with the development of the sleep apnoea syndrome, makes the intense research in this area quite understandable.
Figure 1 shows the anatomy in the area for snoring and obstruction. It is primarily the oropharynx and the hypopharynx. In horizontal position the mandible with its heavy, adjoining palatal curves and soft palate falls back in the pharynx and causes an obstruction. If only the soft palate with uvula falls back, a snoring will occur, but hardly any obstruction.
Several more or less invasive forms of treatment have been suggested and used, and of these the below mentioned still seem to be in widespread use.

NovozentR is an apparatus of the non-invasive type which supposedly increases the airway if inserted in antrum nostril. It is correct that the airway in this region is improved, but to assume that it should result in a termination of the sleep apnea syndrome is unlikely, since the problem, as described above, is situated deeper in the pharynx.
Different kinds of lubricating materials (for example AzonorR) has been introduced – without any remarkable results.
Acupuncture in especially CV23 (Conception Vessel) have been tried on some patients with limited results.
Different kinds of surgery have been (and are still) in use. There are different kinds of UPPP (Uvulo-palato-pharyngo-plastic) (9), partial glossectomy (10) and maxillofacial osteotomy (sagittal split of mandible and LeFort I-osteomy with an advance of of the mandible as well as maxilla) (11)

Extraoral/cranial apparatus for securing a constant overpressure that will prevent the airway from collapsing has been developed in at least two variants: nCPAP (nasal continuos positive airway pressure) (12) and BiPAP (with a kind of physiological respiration possibility) (13).

Viewing these methods one unfortunately has to ascertain that the effect of the various treatments is either too small, the frequency of secondary effects that are close to handicaps is too big, or that the apparatus is socially unacceptable. – The present device is developed on this background; based on a wish for non-invasively, without any irreversible structure changes, and with a social accept as high as possible.

Epidemiology

Obstructive sleep apnoea is stated to occur with a frequency of 1.6% of the total population or 20% of all people over 40, which in the United States of America and Europe with the population sizes of 325 million and 213 million respectively means that 5.2 million and 3.4 million people respectively suffer from the sleep apnoea syndrome!

In Denmark a relative frequency is noted (by spot checks done by specialized doctors). Every week 2 patients see a doctor specialized in ear-, nose-, and throat-problems with the problem that they snore so heavily that they want a treatment. There are in Denmark 400 G.P.s specialized in ear-, nose- and throat-problems, which means that 2 persons x 47 working weeks x 400 G.P.s = 37,600 persons who seek treatment. That is about one half (47%) of the illness-ridden group! Apart from this it is assumed that a far bigger percentage of the population is snoring more or less frequently, and this is by some seen as being incipient sleep apnoea syndrome. The idea to begin the prophylactic treatment at this early state is obvious because in this way many of the mentioned symptoms can be eliminated. Seen this way the need for treatment will probably approach 3% of the total population.

Material and Method

The present study was conducted as a prospective multicenter study. 6 doctors specialized in ear-, nose- and throat-problems participated in the study which geographically spread from north to south in Denmark. Each of the centres received 10 sets of questionnaires and plastic anti-snoring device (Appendix 1 and 2).

The first form was handed out to the patient who together with his/her spouse gave a subjective description of the situation before, during, and after the treatment, while the second form was used by the doctor to note the objective examination of the patient before and after the treatment. A description of several physiological parameters was requested since during the various treatments, and especially during the use of the nCPAP equipment, changes (normalisation) of among other things, HDL, Cortisol etc. have occurred and also cessation of snoring or obstructive apnoea have been noted.

Inclusion criteria

a. all sorts of snoring (with or without obstructive apnea)
b. all adult individuals

Exclusion criteria

a. subjects with dentures (uni- or bimaxillar)
b. children
c. mental diseases
d. pronounced parodontosis

X-ray technique

Lateral cranial shots of the columna cervicalis with facial and calvaria skeleton were conducted.
Focus – film distance was constantly 190 cm. The distance between the centre sagittal plan to the film was approximately 10 cm; the enlargement of the centre sagittal plan was therefore 5.6% and earlier produced control groups can hence be used directly (Solow, 14).

When the above mentioned conditions could not be met, it was noted which technique had been used instead.
The patient took up a horizontal and relaxed position. Two exposures were made: one without and one with the Noiselezz anti-snoring device in situ. – The position of the head was not changed between the two exposures.
Figure 2 shows the X-ray of the patient without the Noiselezz and figure 3 with the Noiselezz in situ.

Craniofacial points and lines

(Ingemarsson, 15) (Figure 4)
NCV4iaT: The tangent from the nasion to the most inferior anterior point on the fourth cervicale vertebrae hy: The most anterior point on the ossis hyoideum

ep: The most posterior point of epiglottis
ep´: The point on the frontal wall of the pharynx determined by the insertion between the perpendicular line to the NCV4iaT on level with the epiglottis point

Craniofacial variable

OPH1: Oropharyngeal distance 1. The vertical distance from the NCV4iaT line on level with the most anterior prominence of atlas from the tongue’s posterior limit to the back wall of the pharynx
OPH2: Oropharyngeal distance 2. The vertical distance measured 15 mm caudally for anterior atlas prominence from the tongue’s posterior limit to the back wall of pharynx
OPH3: Hypo pharyngeal distance 1. The vertical distance measured 30 mm caudally for anterior atlas prominence from the tongue’s posterior limit to the back wall of pharynx
HPH1: Hypo pharyngeal distance 2. The vertical distance measured 45 mm caudally for anterior atlas prominence from the tongue’s posterior limit to the back wall of pharynx
hy-NCV4iaT: Right-angled distance from hyoideum to NCV4iaT
ep-ep´: Distance from epiglottis to epiglottis´

Procedure

• Selection of patients

• The patient is informed about the idea and the analysis (orally and in writing) (Appendix 3)

• Pre-treatment conditions are noted in the forms I and II

• The Noiselezz, an anti-snoring device is handed out

• Post-treatment conditions are noted in the forms I and II

• The horizontal X-ray with and without the anti-snoring device

• Collection of the forms for further analysis.

Results

In the present study 25 men and one woman were examined.

ANTHROPOLOGICAL DATA
From the anthropological data it can be seen that basically all patients are snoring all night (22/24) and that most of them have been snoring for several years (23/24). Approximately 32% (7/22) are experiencing so violent disturbances in their sleep that they actually suffer from narcolepsi (a disposition to fall asleep at the wrong time and place), and that 1/4 directly express that they are having trouble with their concentration!

There was no correlation between weight, height, use of tobacco or alcohol and the severity of the different symptoms.
All test persons used the anti-snoring device in a period of time ranging from one month to three months. Except for one who used it only a couple of times per month, all the others used the device every night or at least a couple of nights per week.
To the question of acceptation of the device more than one half (14/24) answered that they had gotten used to it within a couple of days, while the rest of them expressed that they had not accepted the device, in spite of the fact that they still used it at least a couple of times per week.

The snoring pattern had changed remarkably after the period of habituation; thus, only 2 persons had not felt any difference while 3 had reduced their snoring by 50%, 11 had only few snoring periods after the period habituatution and 7 had totally stopped snoring. Muscular soreness, as well as a soreness in joints and teeth were reported by 2/3 of the subjects, who moreover explained that the symptoms disappeared after a couple of days. None of the participants in the study found the discomfort in teeth, joints or muscles so strongly that they wanted to stop using the device which, as mentioned, was used at least a couple of times per week by 95% of the group. Further, 75% of the group were so enthusiastic about the Noiselezz that they immediately wanted to recommend it to others!
The question of changes in the quality of life after the use of the Noiselezz was answered affirmatively by 37% of the subjects.

X-ray cephalometry

The x-ray cephalometric data ascertains that the variables OPH1, OPH2, OPH3 and HPH1 (pharynx measure) showed a significant increase in the linear dimensions, i.e. more free airway space. This agrees with the anthropological results mentioned above.
Moreover it should be mentioned that the attempt has been made to make an equal gradient between calvaria and columna cervikalis at both exposures.

Results for differences with and without the Noiselezz

Table 1. X-ray cephalometric variables

In the group as a hole an average linear increase of the pharyngal space over the four variables could be ascertained to be no less than 11.93 mm.

In the case of the other variables a significant difference from situations with or without the Noiselezz in situ could not be demonstrated.

Discussion

As mentioned under the results one patient did not accept the device, solely because he had a distinct underhung jaw with an already protruding mandible. Also, several mentioned a discomfort in their muscles, joints or (especially) teeth of longer or shorter durance.

A lot of people have some sort of dental deviation, that be a too close packing of the teeth, facial- or lingual deviating single teeth, rotations etc. etc. that might lead to immediate discomfort after using the Noiselezz. To solve these problems the device is produced in a material that can easily be formed according to individual needs. Together with the Noiselezz comes a small indicator of temperature made of plastic which changes colour from red to black at the temperature of about 70ºC. At this temperature the material is easy to form, and it can be pulled, squeezed or twisted where it is necessary for the sake of the teeth which deviate from the standard/normal dental structure.

The individual adjustment of form can be done in the mouth of the patient or on a model made by the dentist to match the patient’s dental structure.

In the present study, however, none had any special adjustments done, and yet 91% of the group succeeded in reducing their snoring by 50% and 78% of the group basically terminated their snoring completely!
The one patient whom the Noiselezz did not effect could for purely psychological reasons simply not accept a foreign object in his mouth for long.

In the case of contraindications it must be presumed that a notable parodontosis with loose teeth should not without any preceding treatment be exposed to the pressure of the Noiselezz.

Further it must be ascertained that the patient does not suffer from any narrowing of the nasal part of the pharynx. (Which is only the case for a minor part of the total population of persons snoring or suffering form sleep apnoea). If this is the case the problems should probably be treated before experimenting with the Noiselezz.

Conclusion

The present study has shown a considerable effect of the treatment using the new product called the Noiselezz treating obstructive sleep apnoea and snoring documented by a questionnaire survey and an x-ray cephalometric analysis. Thus, probably far more people than earlier have the possibility to seek treatment for their snoring and obstructive sleep apnoea in a very easy, quick, inexpensive and non-invasive way without any irreversible changes of anatomy in the pharynx being done.

The Noiselezz is therefore recommended as a “drug of first choice”, which might later be supplemented with more extensive treatments, if necessary.

Its use might be able to save quite a few resources in general.

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