Sleep-breathing changes achieved by the use of

the FKO activator assessed with an at-home sleep

monitor
CONCEPCIN M. Cynthia, UEDA Hiroshi, MATSUMURA Yu, IWAI Koji, TANIMOTO Kotaro
Department of Orthodontics, Applied Life Sciences,Hiroshima University Institute ofBiomedical & Health Sciences

1 1
SRBD subscale
A B

1 Introductio
n
The use of an oral appliance in adults
has been proven time and again that by
advancing the mandible forward there is
a great improvement in sleep breathing
and overall health, the same principle is
applied by the FKO activator, even
though its intended use is different, it
produces an added benefit in the sleep
breathing patterns of children that
undergo this kind of therapy.
3 Material-
Method
38 children, 19 for test group (age 10.9 +
0.9; BMI 16.2 + 1.4 ), 19 for control group
(age 9.8 + 1.4; BMI 17.6 + 2.1), who fulfill the
requirements shown on Table I, participated
on this study.
Two different questionnaires (ESS
modified for children and SRBD sub-scale)
were administered to both parents and
children.(Figure 1A,1B). Figure 1. Questionnaires used in this study. 1A, the ESS modified for
children; 1B, The SRBD subscale.
Furthermore, oropharyngeal crowding was S N S PML
assessed using the Mallampati Scale (MS). As
N

well as adenoids and nasopharyngeal size So

were assessed by means of lateral

2 Aim cephalometric radiographs(Figures 2 and
Nasopharyngeal area
Ba ad1 Ba
Adenoid area
Ptm
3). ad2
PNS
Ptm
PNS
ANS
A portable sleep monitor (Brizzy Nomics, ANS
Atlas
Line PL
Test was provided
Liege, Belgium) Controlto the patients PL

The aim of this study is to confirm if (Figure 4),group Group evaluate the
as to properly
Figure 2. Reference points used for Figure 3. Reference points used to
besides the intended inducement of changes that may happen when wearing the linear assessment of adenoids. assess adenoid and nasopharynx area.
development of the mandible the FKO activator (Figure
Skeletal
Class II
5). Skeletal
Class I
activator may also help improving
healthy sleep breathing patterns in Completion Completion
of screening of screening
children. questionnair questionnair 1. Forehead
es es
sensor
Two One 2. Chin sensor
successful successful
monitoring monitoring 3. Processing unit
of sleep of sleep
breathing breathing
Table I. Requirements for both groups to be included on Figure 4. The sleep monitor used for Figure 5 . FKO activator used in this
this study. this study. study.

4 Results
II III IV V
Score Test Group Control Group Measurements Test group Control group Mallampati Test group Control group Tonsillar Grade Test group Control group
threshold: Ptm-ad1 (mm) 14.3 12.8 scale
ESS <8 SD +0.60 +0.31 Class I 4 5 Grade o 1 0
SRBD < 0.33%
Ptm-ad2 (mm) 18.8 16.0
ESS 5 + 3.4 3.5 + 1.6 SD +0.97 +0.47
Class II 8 10 Grade 1 8 10
Adenoid area 210.1 167.8
SRBD (%) 0.20 + 0.14 0.16 + 0.1 (mm) +0.70 +0.84
SD Class III 4 2 Grade 2 9 7
Nasopharyngeal 324.1 345.5
SRBDs 0.76 0.71 area (mm) Class IV 3 2 Grade 3 1 2
Cronbach Alpha SD +0.99 +0.88

VI 6A 6B 6C
Variable Point Estimate 95% CI Oxygen Desaturation Index
(Odds Ratio) Indicators of Severity Respiratory Events * *
* *
* 2.25
12 * 18 * * *
*
2.2
* * 16
10
Mallampati Scale 1.5714 0.5020 to 4.9196 14 2.15
P =0.43 8 12
2.1
10
6
8 2.05
Tonsillar grade 0.9091 0.3129 to 2.6415 4 6
P=0.86 4
2

2
2 1.95

0 0
(n/h) RDI ARL CT % TOTAL EVENTS OBSTRUCTIVE CENTRAL MIXED 1.9
(n/h) (n/h)
Control Activator out Activator in Control Activator out Activator in Control Activator out Activator in

Results for the questionnaires used are shown on Table II. Adenoidal and nasopharyngeal size results can be seen on Table III.
Oropharyngeal crowding scores are presented on Table Iv, Table V and Table VI. Finally, outcomes from the sleep monitor are
displayed on Figures 6A-6C. *= P<0.05

5 Summary 6 Discussion 7 Conclusion

From the questionnaires (Table II) it can The FKO activator provides an added
A trend of slightly larger adenoidal size and
be seen that none of the tested groups benefit on sleep-breathing patterns thus
smaller nasopharynx can be seen on the test
suffer from excessive daytime sleepiness improving the general quality of life of the
group, but this is likely to involute with time ,.
nor seem to screen positively for disordered children undergoing this kind of therapy.
Nonetheless, the use of the FKO while
sleep breathing.
sleeping shows a betterment in several items
From the radiographs (Table III) it can be
tested with the monitor which could be
seen that skeletal Class II children seem to
anticipated to be kept throughout.
have a slightly larger adenoidal tissue and a
These benefits could probably be carried on
smaller nasopharynx.
in to adulthood, however this affirmation
Oropharyngeal crowding does not seem
should be tested on a future study.
to be an issue on neither group. (Table IV,
V and VI).
From the sleep monitor (Figures 6A to
6c) it can be confirmed that all indicators of
severity as well as all respiratory events
reduce significantly when wearing the
The activator.
authors declare no conflict of interest
References
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Contact
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<Cynthia Concepcin Medina> 7. Capan et al., ERJVol. 46, No. 59, 2015

<Hiroshima University, Department of Orthodontics, Applied Life Sciences,

Institute ofBiomedical & Health Sciences >
Reagents of Michigan University, used with permission.
Email: cynthiaconcepcion@hiroshima-u.ac.jp License agreement #4710-umich.