Table: Summary of studies about the effects from mandibular advancement...

Table: Summary of studies about the effects from mandibular advancement devices (MADs)
The device designs are classified into monoblock devices and adjustable devices. The monoblock devices were used in a fixed position
or were sometimes adjusted with the help of a dental technician. The adjustable devices are subdivided into those with an adjustment
mechanism located in the Midline and those with Lateral adjustment mechanisms that may permit mouth opening. Adjustable devices
allow continuous titration of mandibular positioning. All studies are reported in chronological order in each section, respectively.
Comparison MAD vs. placebo - Parallel studies
Author
Design
EBM
Patient population
Results
Comments
Hans et al. 1997
RCT, parallel study.
2b
18 patients of 24 (20
RDI changed from 36±28
Patients with severe OSA
[23]
Non-customised MAD
males) with RDI<30
to 21±21 with MAD
used a non-customised
vs. non-advanced
finished the protocol.
(p≤0.05) and from 37±44
device. RDI was
MAD. Monoblock
Age 52±12 yrs
to 47±47 with non-
insufficiently reduced by
devices. 6-8 mm
MAD (n=10); non-
advanced MAD (ns).
MAD, but not at all with
advancement.
advanced (n=8)
Increased RDI in 1/10
non-advanced MAD. RDI
2 weeks treatment.
BMI 29±4; 29±6 kg/m2
patients with MAD and in
may increase with non-
Limited sleep study.
ESS 12±4; 13±5
6/8 with non-advanced
advanced MAD.
device. ESS decreased
with MAD only.
Blanco et al. 2005 RCT, parallel study.
[14]
2b
24 patients (20 males)
AHI changed from 34±15
Small sample size. Some
MAD and non-
with AHI≥10 and at
to 10±12 with MAD
effect on AHI also from
advanced MAD.
least two OSA-
(p<0.01) and from 24±12
non-advanced device,
Monoblock devices.
symptoms were
75% of maximum
randomised.
mandibular
MAD; non-advanced
advancement.
MAD
3 months treatment.
(n=8); (n=7)
Polysomnography
Age 56±12; 53±13 yrs
(PSG)
BMI 28±4 kg/m2 in both Effect on daytime
groups.
to 12±8 with nonadvanced MAD (p=0.05).
57% of the patients had a
complete response
(AHI<5 and the resolution
despite no reduction in
either supine or lateral
AHI. Positional changes
may have influenced the
results
symptoms) with MAD.
sleepiness, snoring and
quality of life only from
MAD.
Petri et al. 2008
RCT, parallel study.
1b
81 patients (66 males)
[30]
MAD vs. non-advanced
out of 93 with AHI of >5 to 25±28 with MAD
sleep apnoea and
MAD vs. no
fulfilled the study.
daytime sleepiness from
intervention.
Mean age was in
Monoblock devices.
between 49-50 yrs,
AHI changed from 39±24
(p<0.001), from 33±22 to
32±25 with non-advanced
MAD (ns) and from 34±26
Significant effects on
MAD compared with
placebo. The first study
Mandible in the most
BMI 31 kg/m2 and ESS to 33±25 with “no
that compares the effects
comfortable protrusive
11-12 in the
intervention” (ns).
of a non-advanced MAD
position. Adjustment if
randomisation groups.
AHI<5 and a resolution in
compared with “no
necessary.
symptoms in 29% of the
intervention”. No
4 weeks study.
patients with MAD. ESS
difference in outcome.
PSG
decreased and quality of
life improved with MAD.
Comparison MAD vs. placebo - Cross-over studies
Author
Design
Mehta et al. 2001
[28]
EBM
Patient population
Results
Comments
RCT, cross-over study. 1b
28 patients with
AHI changed from 27±17
Short evaluation time.
Adjustable MAD
AHI≥10 and ≥2 OSA
(SD) to 14±2 (SEM) with
The study shows a clear
(Lateral) vs. control
symptoms were
MAD and to 30±2 with
effect from MAD
splint in lower jaw.
recruited.
control splint. Lower AHI
compared with a control
Titration until the
24 patients (19 males)
with MAD (p<0.0001).
splint. Better effect in
resolution of symptoms
finished the protocol.
Complete success (AHI<5 milder, less obese
or maximum
Age 48±9 yrs
and resolution of
patients. The
comfortable limit. One
BMI 29±3 kg/m2
symptoms) in 38% of the
acclimatisation period
week with each device.
ESS 10±1
patients and AHI<10 in
may be long for MAD.
1 week wash-out.
54%. Snoring frequency
Acclimatisation: 20±9
was lower with MAD
(5-40) (range) weeks.
(p<0.005). Better effect on
PSG
sleep apnoea in patients
Cephalogram
with milder disease,
smaller neck
circumference, wider
pharynx or a backwardly
angulated mandible.
Gotsopoulos et al. RCT, cross-over study. 1b
73 patients (59 males)
RDI changed from 27±2
Clear effects on
2002 [22]
Adjustable MAD
of 85 with RDI≥10 and
(SEM) to 12±2 with MAD
respiratory variables
(Lateral)
≥2 OSA symptoms
and to 25±2 with control
including snoring from
vs. control splint in
finished the protocol.
splint (p<0.0001 MAD vs.
MAD compared with
upper jaw.
Age 48±11 yrs
control). Complete
control splint. Subjective
Titration until maximum
BMI 29±5 kg/m2
success (RDI<5) with
daytime sleepiness
comfortable limit of
ESS 11±5
MAD was achieved in
decreased also with
advancement.
56% had moderate and 36% of the patients. ESS
control splint. MAD more
4 weeks with each
29% had severe OSA.
frequently normalised
decreased with both
device.
devices. Lower treated
ESS. Many patients
1 week wash-out.
value with MAD. MSL was wanted to continue with
Acclimatisation: 8 (2-
longer with MAD than
the control splint, which
22) (range) weeks.
control. Both subjective
highlights the need for
PSG
and objective snoring
objective control of
MSLT
frequency and intensity
treatment effects.
were lower with active
device (p<0.0001). 99%
of the patients desired to
continue with MAD and
49% with the control
splint. Significantly more
patients reported sideeffects with active device
than with control splint.
Johnston et al.
RCT, cross-over study. 2b
20 patients (16 males)
AHI changed from 32±21
Some effect on sleep
2002 [25]
Monoblock MAD vs.
of 21 with ODI≥10
to 23±23 with MAD and to apnoea from MAD
control device in upper
finished the protocol.
38±25 with control device. compared with a control
jaw.
Age 55±7 yrs
(p=0.01 MAD vs. control). device in patients with
75% of maximum
BMI 32±6 kg/m2
Treatment success
severe OSA. Similar
mandibular
ESS 14±6 kg/m2
(AHI<10) in 33% of the
symptomatic outcome
advancement.
patients with MAD. One of from the devices. Poor
4-6 weeks with each
6 subjects with pre-
success rate in the most
device.
treated AHI>50 had
severely affected OSA
Limited sleep study.
success. ESS and
patients.
reported snoring did not
differ between devices.
Naismith et al.
RCT, cross-over study. 1b
73 patients (59 males)
AHI changed from 27±15
Some aspects of
2005 [29]
Adjustable MAD
of 86 patients with
to 12±12 with MAD and to neurobehavioral
(Lateral) vs. control
AHI≥10 and at least
25±15 with control splint.
functioning improved with
splint in upper jaw.
two OSA-symptoms
(p<0.01 between
MAD compared with a
Titration until maximum
completed the protocol. devices). 36% of the
control splint. Factors
comfortable limit of
Age 48±11 yrs
patients had an AHI<5
which may be as
advancement.
Mean BMI 28 and 30
and 55% had an AHI<10
important as sleepiness
4 weeks with each
kg/m2 in the
with MAD. Improvements
such as fatigue, tiredness
device.
randomisation groups.
in self-reported
and lack of energy
1 week wash-out.
sleepiness, fatigue/energy improved by MAD.
Acclimatisation: 8±4
levels and
weeks.
vigilance/psychomotor
PSG
speed from MAD.
Comparison MAD vs. placebo or CPAP – Parallel study
Author
Design
EBM
Patient population
Results
Comments
Aarab et al. 2011
RCT, parallel study.
2b
Out of 219 eligible
At baseline, mean AHI
Insignificant difference in
[11]
Adjustable MAD
patients, 64 were
was 22, 21 and 20 in the
AHI-reduction between
(Midline) vs. CPAP vs.
included and 57
MAD, CPAP and placebo
MAD and CPAP may be
placebo splint in upper
patients finished the
groups, respectively. With explained by small study
jaw.
protocol.
MAD these values
sample. The p-value was
Most effective of 4
Mean age was 50-55
decreased 16 steps with
0.09. Treatment failure
mandibular positions.
yrs, mean BMI 27-31
MAD, 20 with CPAP and
was found in some
6 months treatment.
kg/m2 and mean ESS
5 with placebo. There was patients who were treated
PSG
10-12 in the
a significant difference
with MAD, but in no
randomisation groups.
between the two active
patient treated with
treatments and the
CPAP. Lower BMI in
placebo intervention
MAD group might have
(p<0.001), but not
influenced the results.
between MAD and CPAP
Placebo effects on
(p=0.09). All interventions symptoms. Best effect on
reduced AHI. Baseline
BMI was lower in the
MAD group than the other
groups. No difference in
symptomatic effects and
compliance between the
three groups. Best effect
of CPAP and poorest
effect of placebo on
snoring. Side-effects were
reported from both MAD
and CPAP, but not from
placebo.
snoring from CPAP.
Comparison MAD vs. placebo or CPAP – Cross-over study
Author
Design
EBM
Patient population
Results
Comments
Barnes et al. 2004 RCT, cross-over study. 1b
114 patients with AHI
AHI changed from 21±1
CPAP was the most
[13]
Adjustable MAD
5-30 were recruited, 80 (SEM) to 14±1 with MAD
effective treatment, but
(Midline) vs. CPAP vs.
(63 males) fulfilled the
(p<0.001), to 5±1 with
produced similar effect on
placebo tablet.
protocol.
CPAP (p<0.001) and to
daytime sleepiness and
Titration until maximum
Age 46±1 (SEM) yrs
20±1 with placebo (ns)
quality of life as MAD.
comfortable limit of
BMI 31±1 kg/m2
(p<0.001 MAD vs.
Placebo tablet ineffective
advancement.
ESS 10±1
placebo; p<0.05 CPAP
on sleep apnoea and
3 months with each
vs. MAD). AHI<10 in 49% daytime sleepiness.
treatment.
of the patients with MAD.
Difficulties to estimate
2 weeks wash-out.
No difference in ESS
effects on
PSG
between CPAP and MAD. neurobehavioral
MWT
Effects on quality of life
functioning because of
and nightly diastolic blood placebo effects.
pressure from MAD
compared with placebo.
No effect on objective
sleepiness from MAD.
Incomplete response on
neurobehavioral
functioning from both
MAD and CPAP. Placebo
effects on some
measurements. Sleepy
and non-sleepy subjects
had similar overall
treatment responses.
Comparison MAD vs. CPAP – Parallel studies
Author
Design
EBM
Patient population
Results
Comments
Lam et al. 2007
RCT, parallel study.
1b
101 patients (79 males) AHI changed from 21±2
All groups had sleep
[26]
Monoblock MAD and
of 109 with 5≤AHI≤40
(SEM) to 11±2 with
hygiene and weight
conservative measures
(ESS>9 for patients
MAD+C (p<0.001), from
control recommendations.
(C) (sleep hygiene,
with AHI≤20) fulfilled
24±2 to 3±1 with CPAP+C CPAP was the most
weight control) vs.
the protocol.
(p<0.001) and from 19±2
effective treatment.
CPAP+C vs. C only.
Mean age 45-47 yrs,
to 21±3 with C only
Conservative treatment
Mandible in the most
BMI 27-28 kg/m2 and
(ns)(p<0.05 CPAP vs.
only, was ineffective on
comfortable protrusive
ESS 12 in the
MAD; p<0.001 MAD vs.
sleep apnoea and weight
position.
randomisation groups.
placebo). All treatments
reduction on a group-
10 weeks treatment.
reduced ESS-scores
level.
PSG
(p<0.05 CPAP vs. MAD).
MAD Improved quality of
life from MAD and CPAP,
but not C. Only CPAPusers reduced weight. No
differences in blood
pressure effects between
the groups.
Hoekema et al.
RCT, parallel study.
2008 [24]
1b
228 patients assessed
AHI decreased from
MAD was less effective
Adjustable MAD
for eligibility. 103
39±31 to 8±14 with MAD
than CPAP on sleep
(Midline) vs. CPAP.
patients (92 males)
and from 40±28 to 2±4
apnoea, but had similar
Titration until the
with an AHI of ≥5 were
with CPAP (p=0.006
symptomatic effects. In
resolution of symptoms
randomised.
CPAP vs. MAD). Effective terms of success rate,
or maximum
MAD (n=51); CPAP
treatment (AHI<5 or ≥50% MAD was not considered
comfortable limit.
(n=52)
reduction of AHI to <20
inferior to CPAP in the
8-12 weeks treatment.
Age 49±10 yrs for both and no symptoms) in 77% whole sample. In patients
PSG
groups.
of the patients with MAD
with severe disease
BMI 32±6; 33±6 kg/m2
and in 83% with CPAP.
CPAP was more
ESS 13±6; 14±6
AHI<5 in 57% in all
effective.
patients, in 84% with mild
to moderate OSA and
31% with severe disease.
No difference in ESS or
quality of life between
treatments.
Comparison MAD vs. CPAP – Cross-over studies
Author
Design
Ferguson et
al.1996 [17]
EBM
Patient population
Results
Comments
RCT, cross-over study. 1b
27 patients (24 males)
AHI decreased from
Non-customised MAD
Monoblock, non-
with symptomatic OSA, 20±14 to 10±7 with MAD
customised MAD vs.
AHI 15-50 were
(p<0.005) and from 18±13 sleep apnoea and
CPAP.
recruited.
to 4±2 with CPAP
daytime sleepiness from
3 mm behind the
AHI 25±9
(p<0.005). CPAP more
CPAP than from MAD.
was used. Better effect on
maximum mandibular
Age 46±11 yrs
effective (p<0.05). With
Snoring still present with
advancement.
BMI 30±5 kg/m2
MAD, 48% received
MAD in 6 patients who
4 months with each
25 patients finished the treatment success
were treatment or
device.
study.
(AHI<10 and relief of
compliance failures. The
2 weeks wash in and
symptoms), 28% had
patients preferred MAD.
2 weeks wash-out.
treatment failure and 24%
PSG
experienced compliance
failure. With CPAP, 62%
received treatment
success and 38%
experienced compliance
failure. 6 of 7 patients with
success from both
devices preferred MAD.
Ferguson et al.
RCT, cross-over study. 1b
24 patients (19 males)
AHI decreased from
Customised adjustable
1997 [18]
Adjustable MAD
with symptomatic OSA, 25±15 to 14±15 with MAD MAD was used. Lower
(Midline)
AHI 15-55 were
(p<0.005) and from 24±17 AHI with CPAP than with
vs. CPAP.
recruited.
to 4±2 with CPAP
MAD. No difference
Titration until the
Age 44±11 yrs
(p<0.005). Lower AHI with between devices in
resolution of symptoms
BMI 32±8 kg/m2
CPAP (p<0.01). Similar
symptomatic effects or
or maximum
ESS 11±3
decrease in ESS from
compliance. Snoring
comfortable limit.
20 patients finished the both devices. With MAD,
improved in 100% by
4 months with each
study.
55% received treatment
CPAP and in 55% with
device.
success (AHI<10 and
MAD. The patients
2 weeks wash in and
relief of symptoms), 40%
preferred MAD.
2 weeks wash-out.
had treatment failure and
PSG
5% experienced
compliance failure. Two
patients increased their
AHI. With CPAP, 70%
had treatment success
and 30% experienced
compliance failure. 7 of 8
patients with success
from both treatments
preferred MAD.
Engleman et al.
RCT, cross-over study. 1b
51 of 97 consecutive
AHI decreased from
CPAP more effectively
2002 [16]
Monoblock MADs vs.
patients with AHI≥5,
31±26 to 15±16 with MAD reduced sleep apnoea
CPAP.
and ≥2 OSA symptoms and to 8±6 with CPAP
80% of maximum
including ESS≥8 or
comfortable mandibular
sleepiness while driving AHI≤5 was found in 19%
advancement.
were recruited.
with MAD and in 34% with monoblock MADs in
8 weeks with each
48 patients (36 males)
CPAP. AHI≤10 was found sleepy, mild and more
appliance.
finished the protocol.
in 47% with MAD and in
Limited sleep study.
Age 46±9 yrs
66% with CPAP. Better
MWT
ESS 14±4
effect from CPAP on
and symptoms and
(p=0.001 CPAP vs. MAD). improved quality of life
symptoms and quality of
life also in milder cases.
No difference in objective
measurement of
sleepiness. Patients who
preferred CPAP were
heavier.
compared with
severe OSA patients.
Randerath et al.
RCT, cross-over study. 1b
20 patients (16 males)
During the first night, AHI
Insignificant effect from
2002 [32]
Adjustable MAD
with 5≤AHI≤30 were
decreased from 18 ±8 to
MAD-treatment after 6
(Lateral) vs. CPAP.
included.
11±8 with MAD (p<0.05)
weeks treatment raises
About two thirds of
Age 57±10 yrs
and to 4±3 with CPAP
the question whether the
maximum mandibular
BMI 31±6 kg/m2
(p<0.01). No difference in effect from MAD may
advancement with no
AHI between devices.
decline. It is possible that
further change.
After 6 weeks, AHI was
more advancement was
PSG during the first
14±11 with MAD (ns) and
needed. MAD was easier
night and after 6 weeks
with each device. No
adjustment of MAD.
3±3 with CPAP (p<0.01).
Lower with CPAP
(p<0.01). No effect from
MAD in any OSA-severity
group at 6 weeks. 30% of
patients had AHI<10 with
MAD. Symptomatic
improvement was similar
with both devices.
Treatment success with
to use than CPAP. Similar
symptomatic
improvement from MAD
and CPAP indicates a risk
that patients continue with
a suboptimal treatment.
MAD was related to a
higher weight and lower
age.
Tan et al. 2002
RCT, cross-over study. 2b
24 patients (20 males)
AHI decreased from
Small study shows similar
[34]
Monoblock MAD or
of 46 with 10≤AHI<50
22±10 to 8±11 with MAD
effects from MAD and
adjustable MAD
were included.
and to 3±3 with CPAP
CPAP on respiratory
(Lateral) vs. CPAP. 2
Age 51±10 yrs
(p<0.001 for both
variables and daytime
months with MAD or
BMI 32±7 kg/m2
devices). ESS decreased
sleepiness, although high
CPAP.
ESS 13±5
with both treatments
success rate with CPAP.
75% of maximum
21 patients completed
(p<0.001). No difference
Patients preferred MAD
comfortable mandibular
the protocol.
in AHI or ESS between
over CPAP.
advancement.
devices. Treatment
Adjustment if
success (AHI<10) with
necessary.
MAD in 67% of the
2 weeks wash-out.
patients and compliance
PSG
failure in 4%. Treatment
success with CPAP in
92% of the patients and
compliance failure in 8%.
17 of 21 (81%) patients
preferred MAD.
Gagnadoux et al.
RCT, cross-over study. 1b
69 patients with AHI
AHI changed from 34±13
Both appliances
2009 [19]
Adjustable MAD
10-60 were recruited,
to 6 (3-14) (median and
effectively reduced
(Lateral) vs. CPAP.
59 were randomised
interquartile range) with
symptoms and AHI,
2 months with each
after successful
MAD and to 2 (1-8) with
although CPAP was more
device after one-night
titration.
CPAP. CPAP more
effective on sleep
effective titration of
Age 50±9 yrs
effective (p=0.001).
apnoea. A negative result
both devices.
BMI 27±4 kg/m2
Complete response
from the titration
PSG
ESS=11±5
(≥50% reduction and
procedure was a weak
Limited sleep study
56 completed the
AHI<5) in 73% with CPAP predictor for treatment
Osler test
protocol.
and 43% with MAD.
failure. Self-reported
Subjective and objective
compliance was higher
sleepiness decreased. No with MAD and the
difference between
majority of the patients
devices. Positive and
preferred that treatment.
negative predictive values
for success from MAD
titration were 85% and
45%, respectively. 70% of
the patients preferred
MAD.
Long-term comparison MAD vs. surgery, CPAP or between appliance designs – Parallel studies
Author
Design
EBM
Patient population
Results
Comments
Walker-Engström
RCT, parallel study.
1b
95 patients with
AHI decreased from 18±3 The first randomised
et al. 2002 [37]
Monoblock MAD vs.
5<AI<25 were included. to 5±3 after one year with
long-term comparison of
UPPP.
MAD (n=32); UPPP
MAD (p<0.001) and was
treatment effects from
Follow-up after 4 yrs.
(n=40) completed the
7±3 after 4 yrs (p<0.01 vs. MADs. Better long-term
Limited sleep study.
4-year follow-up. Age
one year). AHI had
outcome in patients
49 (47-52); 51 (49-53)
decreased from 20±3 to
treated with MAD than in
yrs
10±3 one year after UPPP patients who had
(±95%CI)
(p<0.001) and was 14±3
BMI 27 (26-28) in both
after 4 yrs (p<0.01 vs. one Increased AHI between
groups.
yr). Significantly reduced
undergone UPPP.
one and 4 years from
AHI after 4 yrs, but higher both treatments.
treated value compared
with one-year follow-up
for both treatments. Longterm AHI higher after
UPPP than with MAD.
Ghazal et al. 2009 RCT, parallel study.
[21]
1b
133 patients were
AHI decreased from 23
Both appliances were
Adjustable devices,
assessed. 103 patients (7-32) (median and
effective in the short and
MAD (Lateral) vs. MAD
with AHI 5-40 were
interquartile range) to 9
longer term, although
(Midline). Titration of
randomised.
(0-16) with MAD (Lateral)
there were smaller
mandibular positioning.
MAD (Lateral) (n=51);
and from 21 (7-40) to 5
differences between
Follow-up after 6
MAD (Midline) (n=52)
(0-21) with MAD (Midline) them. It is possible that
months and 24 months.
Age 51±11; 50±11 yrs.
short-term. Better effect
PSG
BMI 26±3 kg/m2 in both from MAD (Midline).
the longer term
effectiveness of a device
groups.
Daytime sleepiness and
may vary in relation to
ESS 8±2; 10±3
quality of life improved
construction details
45 patients fulfilled the
with both appliances. At
including comfort for the
24 months follow-up.
long-term follow-up, AHI
patients.
was 5 with both
appliances. Snoring and
daytime sleepiness
increased between the
follow-ups. Complete
long-term response
(AHI<5) in 35% with MAD
(Lateral) and 25% with
MAD (Midline).
Compliance failure in 26%
with MAD (Lateral) and
42% with MAD (Midline).
Aarab et al. 2011
RCT, parallel study.
2b
21 patients randomised The reduction in AHI after Better effect from CPAP
[12]
Adjustable MAD
to MAD-treatment and
one year was smaller with than MAD in the longer
(Midline) vs. CPAP
22 patients to CPAP-
MAD than with CPAP
term. Similar symptomatic
1 yr. treatment.
treatment from a
(p<0.0001). The mean
effect. More patients
PSG
previous study (Aarab
difference was 4. The
stopped using CPAP
2010) were followed
MAD group had a smaller because of side-effects,
up.
effect on arousal index
but similar proportion of
Age 50±9; 55±10 yrs
(p<0.0001) than the
patients had either side-
BMI 27±3; 31±3 kg/m2
CPAP group. There was
effects or a suboptimal
ESS=12±6; 11±4
no difference between the treatment effect from the
in the MAD-group and
two groups in change of
CPAP-groups,
EDS. Compliance did not
respectively.
differ between the groups.
15 MAD-treated
From study start, 6
patients and 13 CPAP- patients had discontinued
treated patients
CPAP-treatment and two
finished the study
patients had stopped with
protocol.
MAD-treatment because
of side-effects. Another 3
patients had insufficient
effect from MAD and were
recommended CPAP.
treatments.
Comparison between MAD designs – parallel studies
Author
Design
EBM
Patient population
Results
Comments
Tegelberg et al.
RCT, parallel study.
1b
74 patients with
AHI decreased from 16±3 Similar effect from MADs
2003 [35]
Monoblock MAD with
5≤AI≤25 started.
(95%CI) to 6±4 with 50%- with 50% compared with
50% mandibular
50%-MAD; 75%-MAD
MAD (p<0.001) and from
75% mandibular
advancement vs. 75%
(n=29); (n=26)
19±5 to 6±2 with 75%-
advancement after one
advancement.
completed
MAD (p<0.001). No
year in patients with
One year treatment.
5±1; 6±1 mm
difference between
milder OSA. The authors
Limited sleep study.
advancement
devices. Treatment
recommend starting
Age 52 (49-55); 54 (52- success (AHI<10 and
MAD- treatment with 50%
56) yrs (95%CI) at
AI<5) in 79% of the
advancement in this
baseline
patients with 50%-MAD
group of patients.
BMI 27 (26-28); 28 (27- and in 73% with 75%-
1b
29) kg/m2
MAD (ns).
86 men with AI≥20
AHI decreased from 47±5 Higher success rate from
Walker-Engström
RCT, parallel study.
et al. 2003 [36]
Monoblock MAD with
were included. 50%-
to 17±6 with 50%-MAD
75% compared with 50%
50% advancement vs.
MAD; 75%-MAD
and from 50±5 to 16±6
advancement after 6
75% advancement.
(n=37); (n=40)
with 75%-MAD (p<0.001
months in patients with
6 months treatment.
completed.
for both devices). No
severe disease, although
Limited sleep study.
5; 7 mm advancement
difference between them.
both advancements
Age 54 (52-56); 50 (48- Treatment success
reduced the AHI to a
53) yrs
(AHI<10 and AI<5) in 31% similar degree.
(95%CI) at baseline
of the patients with 50%-
Comparable symptomatic
BMI 31±1; 31±1 kg/m2
MAD and in 52% with
outcome from the
(±
75%-MAD (p=0.04
devices.
95%CI)
between devices).
Patients with normalised
AHI were slimmer. ESS
decreased and no
difference between
devices.
Comparison between MAD designs – cross-over studies
Author
Design
Bloch et al. 2000
[15]
EBM
Patient population
Results
Comments
RCT, cross-over study. 2b
24 patients (23 males)
AHI decreased from 23±3 Better symptomatic effect
Monoblock-MAD (M-
with OSA symptoms
(SEM) to 8±2 with M-MAD from monoblock device.
MAD) vs. adjustable
and AHI≥5 or sleep-
and to 9±2 with H-MAD
Patients preferred this
Herbst-MAD (H-MAD)
disruptive snoring with
(p<0.05 for each device).
device. There might be
(Lateral).
arousal index of >20/h. Treatment success
differences in
Adjustment of
Age 51±2 (SEM) yrs
(AHI<10) in 75% of
effectiveness and
mandibular positioning
BMI 27±1 kg/m2
patients using M-MAD
preferences between
with both devices.
ESS 12±1
and in 67% with H-MAD
appliance designs. The
1 week with each
(ns). ESS decreased with need for elastics in the H-
appliance or without
both devices. Better
MAD might be a
any device. Adaptation
subjective outcome with
weakness.
time 156±14 days
M-MAD. 63% of the
(mean±SEM).
patients preferred the M-
PSG
MAD and 4% preferred HMAD.
Pitsis et al. 2002
RCT, cross-over study. 2b
23 patients (20 males)
AHI decreased from 21±2 Two different degrees of
[31]
Adjustable MAD
of 24 recruited
(SEM) to 8±1 with 4-mm-
(Lateral) with 4 mm
completed the protocol. MAD (p<0.001) and to
tested and there were no
interincisal mouth
Age 50±10 yrs
10±2 with 14-mm-MAD
differences in respiratory
opening vs. 14 mm.
BMI 31±5 kg/m2
(p<0.001). No difference
variables or daytime
in AHI, ESS or reported
sleepiness between them.
Titration until maximum
mouth openings were
comfortable limit of
snoring between devices. The patients preferred the
advancement.
4-mm-MAD was preferred device with a smaller
2 weeks with each
by 78% of the patients
device.
and 14-mm-MAD by 22%
1 week wash-out.
(p<0.007 between
Acclimatisation with 4-
devices).
mouth opening.
mm-MAD.
PSG
Rose et al. 2002
RCT, cross-over study. 2b
26 patients (22 males)
RDI decreased from 16±5 Better effect on sleep
[33]
Karwetzky activator
with mild OSA were
to 6±3 with K-MAD and
apnoea from Karwetzky
(K-MAD) vs.
included.
from 16±4 to 7±5 with S-
activator than Silencor
Silencor (S-MAD)
Age 57±5 yrs
MAD (p<0.01 for each
indicates that appliance
(Both Lateral).
BMI 28±3 kg/m2
device). Better effect from stability may be of
75% of maximum
16 patients completed
K-MAD (p<0.01). Similar
importance for the
mandibular
the protocol.
effects on daytime
treatment outcome.
advancement.
sleepiness and snoring
Similar symptomatic
6-8 weeks with each
from both appliances.
outcome from both
device.
More problems during S-
devices.
Wash-out 2-3 weeks.
MAD-treatment in terms
PSG, limited sleep
of repairs.
study.
Lawton et al. 2005 RCT, cross-over study. 2b
49 patients evaluated
AHI changed from 46 (29- The patients had severe
[27]
Herbst-MAD or Twin
for eligibility. 16
68) to 25 (0-45) with
Block-MAD
patients (12 males)
Herbst-MAD and to 34 (9- insufficient treatment
(Both Lateral).
completed the protocol. 63) with Twin Block-MAD. response, which makes
In maximum
Age 45 (24-68) (range) No difference in AHI,
comfortable limit of
yrs
ESS, quality of life or
advancement and
BMI 29 (24-51) kg/m2
side-effects between
adjusted if necessary.
ESS 10 (2-18)
devices. 56% of the
2 weeks wash-out.
patients preferred Herbst-
Limited sleep study.
MAD and 31% preferred
sleep apnoea and an
comparison between
devices difficult.
Twin Block-MAD.
Gauthier et al.
RCT, cross-over study. 2b
16 patients (11 males)
RDI decreased from 10±1 Minor differences in
2008 [20]
Adjustable MADs,
of 19 fulfilled the
to 7±1 with Klearway
objective and subjective
Klearway vs. Silencer.
protocol.
(p<0.01) and to 5±1 with
outcome between the two
Both (Midline).
Age 48±2 (SEM) yrs
Silencer (p<0.001)
MAD designs.
Titrated appliances.
BMI 29±1 kg/m2
(p≤0.05 between
3 months with each
appliances). No difference
device.
in improvement in
PSG
symptoms or quality of life
or compliance between
devices. Klearway was
more comfortable.
Vanderveken et al. RCT, cross-over study. 1b
35 patients (29 males)
AHI changed from 14±12
Significant effect on sleep
2008 [38]
Custom-made MAD CM
of 38 with AHI≤40
to 6±8 with MAD CM
apnoea only from the
vs. thermoplastic
finished at least one
(p<0.01) and to 11±9 with custom-made device. The
MAD TP Monoblock
arm.
MAD TP (ns). Complete
prefabricated device
devices.
Age 49±9 yrs
success (AHI<5 and
could not be
65% advancement with
BMI 28±4 kg/m2
reduced snoring) in 49%
recommended as a
MAD CM and 50% with
ESS=8±5
of the patients with
therapeutic option or as a
MAD TP . 4 months with
23 patients completed
MAD CM and in 17% with
screening tool.
each device.
the study.
MAD TP . Compliance
1 month wash-out.
failure in 6% with MAD CM
PSG
and 31% with MAD TP .
Treatment failure in 34%
with MAD CM and 37% with
MAD TP . 82% of the
patients preferred
MAD CM . 63% of the
patients with MAD TP
failure had treatment
success with the custommade device.
Aarab et al. 2010
Cross-over study.
[10]
2b
17 patients (12 males)
AHI decreased from
The authors recommend
Adjustable MAD
of 20 OSA patients
22±11 to 6±8 in the most
starting the titration
(Midline).
finished the protocol.
effective jaw position
procedure at 50%
Four randomised jaw
Age 49±9 yrs
(p<0.001). The two most
advancement in order to
positions, 0%, 25%,
BMI 27±3 kg/m2
advanced positions were
reduce the initial side-
50% and 75% of
ESS=12±6
most effective on AHI, but effects.
maximal protrusion.
also led to more self-
PSG
reported side-effects.
RCTs investigating other outcomes of MAD therapy
Author
Design
EBM
Patient population
Results
Comments
Gotsopoulos et al. RCT, cross-over study. 1b
67 patients (53 males)
AHI was reduced about
The authors conclude that
2004 [39]
Adjustable MAD
of 75 with AHI ≥10 and 50% with MAD compared oral appliance therapy for
(Lateral) vs. control
≥2 OSA symptoms
with the control splint.
obstructive sleep apnoea
splint in upper jaw.
were randomised.
Significant reduction in
over 4 weeks results in a
4 weeks with each
AHI 27±15
24-hour diastolic blood
reduction in blood
device.
Age 48±11 yrs
pressure of 2±1 mmHg
pressure, similar to that
1 week wash-out.
BMI 29±5 kg/m2
(SEM) from MAD
reported from CPAP.
PSG
61 patients fulfilled the
compared with the control
protocol.
splint (p=0.001), but not in
24-hour systolic blood
pressure. Awake systolic
and diastolic bloodpressure decreased with
3±1 mmHg (p<0.01). No
significant difference in
blood pressure measured
asleep.
Hoekema et al.
RCT, parallel study.
2b
2007 [40]
Adjustable MAD
of 30 with an AHI of >5 lapses of attention during
simulated driving skills
(Midline) vs. CPAP.
completed the protocol. simulated driving was
during MAD therapy.
2-3 months treatment.
AHI 49±33
significantly higher in
Improved driving
PSG
Age 49±11yrs
untreated OSA patients
performance from both
25-min simulated
BMI 33±6 kg/m2
compared with controls.
MAD and CPAP therapy.
driving test at midday.
16 control subjects (13
The lapses of attention
The result must be
males) matched for
decreased from both MAD interpreted with some
age.
and CPAP, with no
caution when generalizing
difference between
to the actual driving
treatments.
situation.
47 of 48 men with an
More signs of sexual
None of the treatments
2b
20 patients (17 males)
The total number of
The first study of
Hoekema et al.
RCT, parallel study.
2007 [41]
Adjustable MAD
AHI of ≥ 5 completed
dysfunction in men with
significantly improved
(Midline) vs. CPAP.
the study.
OSA compared with
male sexual functioning
2-3 months treatment.
Age 49±9 yrs
control subjects. No
after some months
PSG
BMI 31±4 kg/m2
improvement in subjective treatment with MAD or
Testosterone
ESS 13±6
reports on sexual
CPAP.
measurement and
48 age-matched control functioning or
questionnaires.
subjects without any
testosterone levels from
sexual problems.
either MAD or CPAP.
28 patients (25 males)
Half of the untreated
Preliminary data in a
Hoekema et al.
RCT, parallel study.
2b
2008 [42]
Adjustable MAD
of 51 with AHI>20 and
patients with moderate to
small sample indicates
(Midline) vs. CPAP.
without cardiovascular
severe OSA without
that cardiac function
2-3 months treatment.
disease were included. cardiovascular disease
PSG
AHI 52±24
had left ventricular
MAD- treatment of
Echocardiography and
Age 50±10 yrs
hypertrophy, left
patients with moderate to
measurements of
BMI 33±5 kg/m2
ventricular dilatation or
severe OSA.
natriuretic peptides.
16 patients completed
elevated natriuretic
all parts.
peptides. Significant
improves from effective
improvement in natriuretic
peptides was recorded
during MAD- treatment.
Trzepizur et al.
RCT, cross-over study. 2b
12 of 17 patients with
AHI decreased from 40
Both appliances improved
2009 [43]
Adjustable MAD
OSA [19].
(31-49) to 14 (7-18) with
endothelial reactivity with
(Lateral) vs. CPAP.
Untreated samples
MAD and to 2 (1-8) with
no difference between
2 months treatment.
without cardiovascular
CPAP (p<0.05 for both).
them, despite that treated
PSG
disease:
Acetylcholine induced
AHI was higher with
Measurement of micro
9 controls with AHI 6
vasodilatation was smaller MAD. Higher self-
vascular reactivity.
(4-11), median
in OSAS patients than in
reported compliance with
(interquartile range)
matched controls. The
MAD. The first
12 patients with AHI 32 vascular reactivity
randomised study of
(24-51).
increased with both
effects on endothelial
Median age ranged in
treatments (p<0.05). No
reactivity from MAD-
between 42 and 56 yrs difference between them.
and BMI was in
The increase correlated
between 27 and 29.
with the decrease in
nocturnal oxygen
desaturations from
treatment.
treatment.
Clinical trials highlighting particular aspects of MAD therapy such as the mechanism of the device or predictors of success
Author
Design
EBM
Patient population
Results
Comments
Kato et al. 2000
Case series.
4
37 of 43 patients with
Each 2-mm mandibular
Experimental study
[52]
Monoblock MAD with
ODI>10 accepted to
advancement produced
showing that the
2-, 4-, and 6-mm
participate.
approximately 20%
improvement of both
advancement. At least
ODI 26 (11-72)
improvement in number
nocturnal oxygenation
one week
(95%CI)
and severity of nocturnal
and pharyngeal
acclimatisation before
Age 49 (27-67) yrs
desaturations.
collapsibility was dose-
trial. Measurements of
BMI 29 (23-40) kg/m2
Advancement of
dependently associated
pharyngeal closing
Pharyngeal closing
mandibular position
with the degree of
pressure.
pressure was
produced dose-dependent mandibular advancement.
Oximetry
evaluated in 6 patients. closing pressure reduction
of all pharyngeal
segments.
Lowe et al. 2000
Case series.
[54]
4
38 patients (36 males)
RDI decreased from 33±2 Objective measurement
Adjustable MAD
with RDI>15 were
(SEM) to 12±2 with MAD
(Midline).
included.
(p<0.0001). RDI<15 and a for MADs in accordance
Compliance monitor.
Age 44 (34-61) (range) resolution of symptoms in with what is achievable
of compliance is possible
yrs
71% of the patients. The
BMI 30 (21-39) kg/m2
index of agreement was
The compliance
0.99 between the
for CPAP.
monitor was tested in 8 compliance monitor clock
Liu et al. 2001 [53] Case series.
4
subjects.
time and patients’ reports.
47 patients (42 males)
AHI decreased from
Ordinary cephalograms
Adjustable MAD
with symptomatic OSA. 40±17 to 17±12 with MAD that often are available in
(Midline).
Age 49 (25-80) (range) (p<0.01). Better treatment dental practice were used
PSG
yrs
response at lower age or
together with
Upright cephalogram in
BMI 30 (22-55) kg/m2
BMI or in patients with
physiological data to
the natural head
19 patients completed
smaller upper airways.
predict treatment success
position.
the study.
Dental and craniofacial
for MAD.
predictors were identified.
Sanner et al. 2002 Case series.
[57]
4
15 patients (14 males)
AHI decreased from
The airway patency
Adjustable MAD
with OSA.
20±15 to 7±7 with MAD
assessed by MRI during a
(Lateral).
Age 57±9 yrs
(p=0.001). Treatment
Müller manoeuvre while
PSG
BMI 31±6
success (≥ 50% reduction wearing MAD might be
MRI during a Müller
13 patients fulfilled the
and AHI<10) in 54% of
predictive of treatment
manoeuvre with and
protocol.
the patients. Five of 7
without MAD in supine
responders had no
position.
significant pharyngeal
success with MAD.
obstruction during the
Müller manoeuvre with
MAD, while 4 of 6 nonresponders had persistent
obstructions.
Skinner et al. 2002 Case series.
[58]
4
14 patients (13 males)
AHI decreased from
Small study showed that
Adjustable MAD
of 15 with OSA
34±22 to 10±5 (p=0.001).
cephalometry had limited
(Midline).
10≤AHI≤40 or CPAP-
The baseline distance
value for prediction
PSG
intolerance finished the between the hyoid bone
Cephalogram in supine
study.
and the mandibular plane
position.
Age 48±11 yrs
was the only
6 to 8 weeks treatment.
BMI 29±5 kg/m2
cephalometric variable
associated with a
successful clinical
outcome.
purposes.
Ng et al. 2003 [3]
Case series.
4
10 patients (9 males)
AHI decreased from 25±3 MAD decreased the
Adjustable MAD
with AHI≥10 and ≥2
(SEM) to 13±5 (p<0.05)
upper airway collapsibility
(Lateral).
OSA symptoms.
and upper airway closing
during sleep, particularly
After one week wash-
Age 44±12 yrs
pressure decreased in
in responders. Upper
out, upper airway
BMI 31±6 kg/m2
Stage 2 sleep and in slow airway closing pressure
closing pressure during
wave sleep with MAD
sleep, with and without
(p<0.05). The reduction in useful for prediction
MAD, was assessed.
pharyngeal collapsibility
PSG
was larger in responders.
Fleury et al. 2004
Case series.
[50]
4
measurements might be
purposes.
40 of 44 patients (36
AHI decreased from
Adjustable MAD
males) with OSA
46±21 to 12±14 with MAD of the titration procedure,
(Lateral).
completed the protocol. (p<0.001). 91% of the
which was performed
Titration with oximetry.
Age 57±9 yrs
patients needed
based on the combined
PSG
BMI 28±4 kg/m2
increased advancement
improvement in
ESS 12±4
from initial 80% of
symptoms and oximetric
maximal protrusion. 64%
recordings.
of the patients had
AHI<10 and a resolution
Highlights the importance
of symptoms after a mean
of 4 advancements.
Marklund et al.
Case series.
2004 [55]
4
619 of 630
AHI was reduced from a
Monoblock MAD.
consecutively treated
mean of 21 (1-74) (range) study that identifies
Follow-up after
patients (508 males)
to 8 (0-72) (p<0.001).
predictors of treatment
573±521 days.
were followed-up.
72% of the patients with
success in a cohort of
Limited sleep study.
Age means: 51 yrs in
an AHI of ≥10 before
consecutively treated
men and 55 yrs in
treatment had an AHI of
patients. 76% of the
women (p<0.001). 277
<10 with MAD. Treatment patients used the device
patients had sleep
success related to female after one year.
apnoea recordings with gender. Men who had
the device.
supine dependent sleep
apnoea or men who did
not increase in weight had
a better treatment
outcome.
Large non-randomised
Kyung et al. 2005
Case series.
4
14 patients (12 males)
AHI decreased from
Advancement of the
[2]
Adjustable MAD.
with AHI>5 and arousal 45±27 to 11±23 with MAD mandible with MAD
CT scan and
index >20 were
(p<0.001). The
produces primarily a
cephalogram during
included.
retropalatal and
lateral widening of the
wakefulness.
Age 50±16 yrs
retroglossal cross-
upper airway.
BMI 25±3 kg/m2
sectional areas increased
(p<0.05) with MAD. The
enlargement of pharynx
was greater in the lateral
than in the sagittal
dimension.
Coruzzi et al. 2006 Case-control study.
[47]
3b
10 OSA patients (6
AHI decreased from 18±1 Improved cardiac
Monoblock MAD.
males), otherwise
(SEM) to 4±1 with MAD.
automatic modulation
3 months treatment.
healthy.
Improved cardiac
from MAD-treatment in
Heart rate, blood
Age 48±10 yrs
autonomic modulation
milder, otherwise healthy
pressure and indices of
BMI 27±1 kg/m2
from MAD- treatment of
OSA patients may have
autonomic cardiac
10 matched controls (5 OSA-subjects. No
favourable implications
regulation.
males).
for the prevention of
difference in treated
Limited sleep study.
values between OSA
cardiovascular disease.
patients and control
subjects.
Dort et al. 2006
Case series.
[49]
4
33 of 38 patients (36
MAD therapy was
The study shows a
Remotely controlled
males) with RDI≥5
successful at target
titration procedure for
MAD for prediction.
fulfilled the protocol.
mandibular protrusion in
MADs in accordance with
PSG
RDI 27±18
80% of subjects who had
CPAP titration. The
Age 45±10 yrs
a successful test with the
method points out a
BMI 30±6 kg/m2
remotely controlled MAD
possible prediction
and failed in 78% of those method for MADs. This
who had an unsuccessful
method may also be used
test outcome.
to find the optimal
mandibular positioning.
Ng et al. 2006 [56] Case series.
4
12 patients (11 males)
AHI decreased from 22±3 The results indicate that
Adjustable MAD
with AHI≥10 and ≥2
(SEM) to 9±2 with MAD
primary oropharyngeal
(Lateral).
OSA symptoms.
(p=0.01). All 4 patients
collapse predict treatment
After one week wash-
Age 51±9 yrs
with primary
success with MADs.
out, upper airway
BMI 28±4kg/m2
oropharyngeal collapse
closing pressure and
had treatment success
site of collapse during
(AHI<5) with MAD. Only
sleep, with and without
one of the 8 patients with
MAD, was assessed.
primary velopharyngeal
PSG
collapse had a successful
outcome.
De Backer et al.
Case series.
4
10 OSA patients (8
The results indicated that
The results suggest that
2007 [48]
Monoblock MAD.
males) with AHI<40 (1- a predicted decrease in
the outcome of MAD-
PSG
31) (range).
upper airway resistance
treatment can be
Upper airway imaging
Age: 44-60 yrs
and an increase in upper
predicted using this upper
techniques combined
BMI: 24-34 kg/m2
airway volume correlate
airway modelling
with computational fluid
with both a clinical and an technique.
dynamics for
objective improvement
prediction.
from MAD.
Itzhaki et al. 2007
Case-control study.
[51]
3b
16 sleepy patients (11
AHI decreased from
Improved endothelial
Adjustable MAD
males) of 25 with
30±19 to 18±11 after 3
function was found after
(Lateral).
AHI≥10
months and to 20±12 after one year MAD-treatment,
After 3 months and one
Age 54±8 yrs
one year with MAD (p<
although apnoeic events
year.
6 untreated OSA
0.005 for both).
were not completely
Markers of oxidative
patients.
Endothelial function and
eliminated. A reduction in
stress and evaluation
Age 43±11 yrs
levels of oxidative stress
cardiovascular
of endothelial function.
10 matched controls.
markers improved with
complications from
Age 50 ±4 yrs
MAD. After one year there treatment still needs to be
BMI: 28 kg/m2 in all
were no differences
groups.
compared with reference
shown.
levels.
Zeng et al. 2007
Case series.
[60]
4
54 patients (40 males)
The results suggest that
A method that may be
Adjustable MAD
with OSA and at least
flow-volume curves, in
useful to predict treatment
(Lateral).
two symptoms were
combination with BMI,
effects from MADs is
PSG
included.
age and baseline AHI
presented.
Spirometry
Mean age 51 and 53
may have a role in the
yrs and BMI 28 and 31
prediction of treatment
kg/m2 in responders
response with MAD
and non-responders,
(>50% reduction in AHI).
respectively.
Zeng et al. 2008
Case series.
4
38 OSA patients (29
Baseline nasal airway
[61]
Adjustable MAD
males) were eligible for resistance in sitting
become useful to predict
(Lateral).
the study.
treatment effects from
PSG
Mean age 51and 55 yrs responders (≥50%
Rhinomanometry
and
position was lower in
A method that may
MADs is presented.
reduction in AHI)
BMI 29 and 34 kg/m2 in compared with nonthe responders and
responders.
non-responders,
respectively.
Chan et al. 2010
Case series.
[1]
4
69 consecutive patients AHI changed from 27±15
The study elucidated the
Adjustable MAD
with AHI≥10 and at
to 12±13 with MAD. With
mechanism of MAD
(Midline).
least two OSA-
MAD, there was
regarding its influence on
PSG
symptoms were
an increase in the total
the upper airway
MRI
recruited.
airway volume,
dimension in good-
Age 51±10 yrs
predominantly because of responders and poor-
BMI 29±5 kg/m2
an increase of the
responders. The upper
velopharynx with a lateral airway imaging was
displacement of the
performed in supine
parapharyngeal fat
position during
pads away from the
wakefulness. These
airway and anterior
results might be of help
movement of the tongue
for prediction purposes.
base muscles. The
increase in upper airway
calibre with MAS occurred
only in responders.
Chan et al. 2010
Case series.
[45]
4
18 responders (AHI-
The upper airway collapse Nasendoscopy may
Adjustable MAD
reduction≥50%); 17
visualised by
(Midline).
non-responders.
nasendocopy was greater the prediction of
PSG
Age 54±12; 56±10 yrs
in non-responders than in treatment success with
Nasendoscopy
BMI 29±5; 31±5 kg/m2
responders with MAD in
Müller manoeuvre
become a useful tool for
MADs.
situ during a concomitant
Müller manoeuvre.
Tsuiki et al. 2010
Case series.
[59]
4
35 patients of 38 who
AHI decreased from 36 to The study shows an
Monoblock MAD.
had used CPAP for 6-
12 (5-26) with MAD
accessible prediction
2-3 weeks washout.
13 months.
(p<0.001). Treatment
method, since many
PSG
Age 55 (41-66) yrs
success (AHI<5 and
patients have tried CPAP
median (interquartile
>50% reduction in AHI)
before MAD therapy is
range)
was associated with a
initiated. More
BMI 26 (24-29) kg/m2
lower CPAP-pressure.
prospective testing is
Patients with CPAP-
necessary.
pressure ≥11 were
unlikely to respond to
MAD therapy.
Bosshard et al.
Case series.
2011 [44]
4
33 consecutive patients Complete or
This method that is
Adjustable MAD
(24 males) were
partial success was seen
performed during
(Midline).
recruited.
in 14/17 subjects with
wakefulness has potential
PSG
26 patients completed
twitch-induced
for prediction of success
Phrenic nerve
the study.
oropharyngeal collapse
with MAD.
stimulation.
Age 51±11 yrs
and in 4/12 patients with
BMI 28±4 kg/m2
velopharyngeal closure.
ESS 11±5
Treatment response was
significantly different in
subjects with twitch-
induced
oropharyngeal and
velopharyngeal collapse
(OR 9.5, 95% CI 1.6 to
52.7).
Chan et al. 2011
Case series.
4
35 patients
25 patients were
[46]
Adjustable MAD
commencing treatment responders and 10
did not have sufficient
(Lateral).
of OA with a custom-
patients were non-
strength to reliably predict
PSG
made MAD were
responders. Response
the response to treatment
Spirometry
recruited.
was defined as ≥50%
of OSA with MAD. A
Age 52±11yrs
reduction in AHI. A
combination of a
BMI 32±11kg/m2
combined cut-off of an
functional and structural
AHI 30±18
inspiratory flow rate at
assessment of the upper
50% of vital capacity
airway might be tested for
(MIF 50 ) less than 6.0 L/s
predictions of success
and a ratio of the
with MAD.
expiratory flow rate at
50% of vital capacity to
This prediction method
MIF 50 of greater than 0.7
correctly classified 49% of
the patients. It had a
sensitivity of 36% and a
specificity of 80%.