D.D.S., Ph.D., Natashia Ingemarsson-Matzen
Dansk Resumé
Der beskrives en
ny behandlingsteknik ved tilfaelde af obstruktiv soevn apnoe og snorken. Den
nye teknik indbefatter en bloedtblivende plastskinne til oral anvendelse, med
det formaal at protrudere mandiblen i forhold til overkaeben idet dette vil
sikre frie oevre luftveje.
Undersoegelsen er tilrettelagt som en multicenterundersoegelse.
Der er foretaget en raekke observationer, herunder kranieroentgenundersoegelser
i rygleje.
Den roentgencephalometriske analyse kunne bekraefte de oegede dimensioner i
pharynxrummet, hvilket maa formodes at vaere den direkte aarsag til forbedrede
forhold efter behandling.
Den overvejende del af de beskrevne tilfaelde har baade subjektivt og objektivt
forbedret livskvaliteten for de paagaeldende; baade i form af stoerre
arbejdsevne, bedre omgaengelighed, stoerre sexual lyst/-kraft etc.
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 capabillities, 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
airwayspace in the pharynx.
Obstructive Sleep Apnea Syndrome (OSAS), Snoring, Plastic material, Noiselezz
Cephalometrics, Pharynx.
Obstructive sleep apnea 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 overfrequency in workrelated accidents: Survey material from Israel
relates 52% of the workrelated accidents to persons with apnea 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 apnea 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
apnea 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 af the sleep apnea 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 horisontal 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 continous 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-invasivity, without any irreversible structure changes, and with a
social accept as high as possible.
Obstructive sleep apnea 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 apnea
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
apnea 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.
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
centers received 10 sets of questionaires 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 parametres 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 apnea have been noted.
Inclusioncriteria
a. all sorts of snoring (with or without obstructive apnea)
b. all adult individuals
Exclusioncriteria
a. subjects with dentures (uni- or bimaxillar)
b. children
c. mental diseases
d. pronounced parodontosis
Lateral cranial shots of the
columna cervikalis with facial and calvarie skeleton were conducted.
Focus - film distance was constantly 190 cm. The distance between the
centersagittal plan to the film was approximately 10 cm; the enlargement of the
centersagittal plan was therefore 5.6% and earlier produced controlgroups 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 horisontal 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.
(Ingemarsson, 15) (Figure
4)
NCV4iaT: The tangent from the nasion to the most inferior anterior point
on the fourth cervikale 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
epiglottispoint
OPH1: Oropharyngeal
distance 1. The vertical distance from the NCV4iaT line onlevel 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 messured 15 mm
caudally for anterior atlas prominence from the tongue's posterior limit to the
back wall of pharynx
OPH3: Hypopharyngeal distance 1. The vertical distance messured 30 mm
caudally for anterior atlas prominence from the tongue's posterior limit to the
back wall of pharynx
HPH1: Hypopharyngeal distance 2. The vertical distance messured 45 mm
caudally for anterior atlas prominence from the tongue's posterior limit to the
backwall of pharynx
hy-NCV4iaT: Right-angled distance from hyoideum to NCV4iaT
ep-ep´: Distance from epiglottis to epiglottis´
1. Selection of patients
2. The patient is informed about the idea and the analysis (orally and in
writing) (Apendix 3)
3. Pre-treatment conditions are noted in the forms I and II
4. The Noiselezz, an anti-snoring device is handed out
5. Post-treatment conditions are noted in the forms I and II
6. The horisontal X-ray with and without the anti-snoring device
7. Collection of the forms for further analysis
In the present study 25 men and one woman were examined.
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 correllation between weight, height, use of tobacco or alcohol and
the severity of the different symptoms.
All testpersons 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 acception 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 dissappeared 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
enthusiatstic 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.
The x-ray cephalometric data ascertains that the variables OPH1, OPH2,
OPH3 and HPH1 (pharynxmeasure) showed a significant increase in the linear
dimensions, i.e. more free airwayspace. 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 calvarie and columna cervikalis at both exposures.
Results for differences with and without the Noiselezz
|
Variable |
Average |
Disperssion |
t-value |
p-value
Wilcoxon's one sample test |
|
OPH1 |
2.9729 |
3.7348 |
3.90** |
0.00065*** |
|
OPH2 |
2.0146 |
4.4729 |
2.21* |
0.01457** |
|
OPH3 |
2.5354 |
5.0487 |
2.46* |
0.00378** |
|
HPH1 |
4.4250 |
7.2340 |
2.87** |
0.00003*** |
|
NSL/SVT |
-0.8708 |
3.4208 |
-1.25 |
0.26176 |
|
OPH1+OPH2+OPH3 |
7.5229 |
10.2530 |
3.59*** |
0.00112*** |
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.
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 neccessary 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, noone had any special adjustements 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 constraindications it must be pressumed 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 apnea).
If this is the case the problems should probably be treated before
experimenting with the Noiselezz.
The present study has shown a
considerable effect of the treatment using the new product called the Noiselezz
treating obstructive sleep apnea and snoring documented by a questionaire
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 apnea 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
neccessary.
Its use might be able to save quite a few ressources in general.
1. Douglas, N.J.: The Sleep apnoe/hypopnoea syndrome and snoring. BMJ
1993; 306: 1057-1060.
2. Ferbere, C. et al.: Syndrome d'apnees du sommeil. L´ence'phale 1992; 8: 361-367.
3. Engman, M.: Understanding and underwriting sleep apnea. Proc Annu
Meet Med Sect Am Counc Life Insur 1992; 117-127.
4. Maniglia, A.J.: Sleep apnea and snoring, an overview. ENT 1993;
72(1): 16-19.
5. Lavie, P: Sleep habits and sleep disturbances in industrial workers
in Israel. Sleep 1981; 4: 147-158.
6. Redline, S. and Young, T.; Epidemiology and natural history of
obstructive sleep apnea. ENT 1993; 72(1): 20-26.
7. Findley, L.J. et al.: Automobile accident involving patients with
obstruction sleep apnea. Am
Rev Respir Ids 1988; 138: 337-340.
8. Wiemann, J. et al.: Schlafapnoesyndrome. Dtsch Med Wschr 1992; 117:
1928-1934.
9. Fairbanks, D.N.F.:
Uvulopalatopharyngoplasy: strategies for success and safety. ENT 1993; 72(1):
46-51.
10. Fujita, S.: Obstructive sleep apnea syndrome; pathophysiology, upper
airway evaluation and surgical treatment. ENT 1993; 72(1): 67-76.
11. Hochban, W. et al.: Die chirurgische Behandlung der obstruktiven
Schlafapnoe durch gesichtsskelettverlagernde Eingriffe unter Berucksichtigung
cephalometricher Parameter. Pneumologie 1993; 47: .194-200.
12. Jennum. P.: Cortisol and adrenergic activity in patients suffering
from obstructive sleep apnea before and after nasal CPAP treatment. Sleep 1990; 426-428.
13. Becker, H. et al.: Indikation und applikation der BiPAP-theraphie. Pneumologie 1993; 47: 184-188.
14. Solow, B.: The pattern of craniofacial associations. A morphological
and methodological correlation and factor analysis study on young male adults. Acta
Odontol. Scand. 1966; 24: Suppl 46: 1-174.
15. Ingemarsson, N.S.: Kraniofacial morfologi hos patienter med
akondroplasi. Thesis, Eget tryk 1987.
Figure
1.
The pharyngal area for narrowing
Figure 2.
X-ray cephalogram. Vertical position without Noiselez in situ
Figure 3.
X-ray cephalogram. Vertical position with Noiselez in situ
Figure 4.
X-ray cephalometric points, lines and variables
Figure 5.
The Noiselezz in natura
Appendix 1.
Questionaire 1
Appendix 2.
Questionaire 2
Appendix 3.
Written information for the patient
(front)
(Pilotstudy on the effect of mouth-inserted
anti-snoring-device)
Doctor's name (stamp)
Mark the proper answer with a cirkel or underlining; it is in some questions
possible to go into detail, and further comments can be given at the bottom.
Patient's name and address Male Age Female
ANAMNESIS:
How often do you snore?
All night Several times Few times A couple of times
per night per nights per week
Do you snore when taking a nap? Yes No Don't know
How long have you been snoring?
1 week 1 month 3 months ½ year Several years All life
Do you share the bedroom with your spouse/partner? Yes No No spouse/partner
If No, for how long have you been sleeping alone? 1 month ½ year 1 year Several
years
Do you suddenly fall asleep during the day? Yes No Don't know
Are you having problems concentrating? Yes No Don't know
What is the worst thing about snoring?
Describe in your own words:
How big is your consumption of tobacco? (amount and kind)
How big is your consumption of alcohol? (amount and kind)
How big is your consumption of medicine? (amount and kind)
RESULTS AND EXPERIENCES:
How often did you use the device? Every night A couple of times A couple of
times Never
per week per month
How long was your period of habituation?
Immediate habituation A couple of hours One night Several days No
How has your pattern of snoring been since the period of habituation?
I have not noticed I have reduced Now I have very few I have stopped
any difference the snoring periods snoring periods snoring!
by 50% per night
Has the usage changed your life / lifequality? Yes No Don't know
If Yes:
Do you feel more refreshed in the daytime Yes No Don't know
Has your family/friends noticed any diffrence? Yes No Don't know
Has your general health been improved? Yes No Don't know
Have you noticed any changes in your dental system? Yes No Don't know
(sore teeth, muscles or joints)
Have you noticed any positive circumstances concerning the use of the device?
Yes No Don't know
If Yes:
(Describe in your own words)
Have you noticed any negative circumstances concerning the use of the device?
Yes No Don't know
If Yes:
(Describe in your own words)
What should the device cost in your opinion?
Less than 100 kr 100-300 kr 300-500 kr 500-800 kr more than 800 kr
Would you recommend this device to other people? Yes No Don't know
Other comments:
Appendix 2
OBJECTIVE EXAMINATION:
Patient's name: Physicians Stamp
Height: Weight: Bloodpressure (S/D):
What treatment would you normally offer the patient?
Apnea index:
(if known)
Oropharyngal condition (Fibroscophy):
Enlarged uvula
Slack palatal curves
Enlarged tongue
Mandibular prognathy
Other conditons you find relevant for judging the patient's positive / negative
success:
RESULT after the use of the device:
Changes in the oropharyngal conditon? (Describe:)
Bloodpressure after the period of treatment: Systolic Diastolic
Thank you for your coorporation.
Sincerely yours
Natashia Ingemarsson-Matzen
Written information for the patient
2 copies
are handed out. One is signed by the patient and returned in order to documente
that the patient has received information on the idea and analysis! At the same
time the patient is orally informed by the doctor who is giving the treament
about the free choice of his/her paticipation and furthermore the possibility
to resign at any time should he/she wish to do so.
Tests have shown that snoring and the attached sleep apnea illnes, which can be
recognized by interruptions in the sleep because of breatning difficulties, can
be treated with various techniques.
The purpose of this study is to test a new approach to the treatment of snoring
and the sleep apnea illness. Your answers and the results of the examination
are of cause anonomous.
The new technigue consists of a double ringlike structure made of a soft
material which you insert in your mouth before going to sleep. The ringlike
anti-snoring device is folded so that it resembles a horseshoe. It is inserted
in your mouth so that the lower jaw is pulled forward as an underhung jaw. The
jaws have free mobility and you can breathe through the mouth or nose according
to your own choice. By holding the lower jaw in an
"underhung-jaw-position" improved airways are created in the pharynx.
In this way both the noise caused by snoring and the typical respiration
difficulties are avoided.
Before the anti-snoring device is handed out, we ask you to fill out the front
page of your questionaire, and your doctor will conduct an examination of your
nose/pharynxarea.
The use of the device is harmless, but if you suffer from parodentosis you
should not participate in this survey before you have received treatment for
your parodentosis.
Please be aware that this is a new device that requires habituation. It is only
natural that you may experience discomfort or pain in your joints, muscles and
teeth. The discomfort will usually disappear after a couple of days' use, and
you will find it a natural part of yourself, even during a brief nap.
An x-ray examination is to be taken of the position of the jaws in order to
make a comparison to the cranium and neck; one examination will be made with
the device inserted and one without. The x-ray examination is harmless in so
far that special amplifiers will be used to illuminate the x-ray picture; this
way the radiation is reduced to the same amount as when a normal x-ray picture
at the dentist's is taken.
After 2 or 3 weeks we ask you to describe your results and experiences with the
device by filling out the other side of the questionaire.
This study can be important for a subsequent recognition of the product and for
the treatment of sleep apnea (the troubled respiration during sleep) and
snoring, and therefore it is essential that as many people as possible should
participate.
Participation is voluntary and you are of course free to stop your participation
at any time. With kind regards
I have received information, understood, read and received a copy of this
document.
D.D.S., Ph.D..
Natashia Ingemarsson-Matzen
Toftegaards Allé 7, 2500 Valby
36 17 70 50
