The Journal of Otolaryngology, Volume 33, Number 3, 2004

Snoring and Obstructive Sleep Apnea:

Compliance with Oral Appliance Therapy
Leslie C. Dort, DDS, MSc, and Jabeen Hussein, MSc

Abstract
Objective: To assess the effectiveness of oral appliances in clinical practice.
Design: Survey of 110 subjects.
Setting: Hospital-based dental practice.
Methods: Questionnaire.
Main Outcome Measures: Compliance and control of sleepiness and snoring.
Results: Fifty-seven percent of respondents were compliant with therapy, reporting control of sleepiness and snoring.
Conclusions: More than 50% of those on oral appliance therapy reported continued use after at least 18 months.
Sommaire
Objectif: Evaluer lefficacit des appareils buccaux dans une pratique clinique.
Devis: valuation de 110 sujets.
Localisation: Pratique dentaire hospitalire.
Mthode: Questionnaire
Variables: Compliance et contrle de la fatigue diurne et du ronflement.
Rsultats: Cinquante-cinq pourcent des rpondants affirment tre compliants et contrler leur fatigue et leur ronflement.
Conclusions: Plus des 50% des patients rapportent continuer dutiliser leur appareil buccal aprs au moins 18 mois et obtenir
un soulagement de leurs symptmes.
Key words: compliance, obstructive sleep apnea, oral appliances, therapy

S leep-disordered breathing (SDB) includes obstructive

sleep apnea (OSA) and snoring. OSA, which is charac-
terized by periodic disruptions of breathing during sleep
owing to the collapsibility of the pharynx, affects up to
6% of adults.1 Snoring is a concern for up to 65% of the
adult population.2,3 OSA is considered to be the severe
end of the spectrum of SDB, whereas snoring without
any symptoms is at the mild end.4 SDB is associated with
an increased risk of motor vehicle and occupational acci-
dents, hypertension, fatigue, cognitive impairment, exces-
sive daytime sleepiness, and diminished quality of life.5,6
Treatment for SDB includes medical intervention,
continuous positive airway pressure (CPAP), oral appli-
ances (OAs), and surgery. Behavior modification,
weight reduction, and steroid therapy for nasal conges-
Received 10/03/03. Received revised 28/08/03. Accepted for pub-
lication 08/09/03.
Leslie C. Dort: Department of Surgery, Faculty of Medicine, Uni-
versity of Calgary, Calgary, AB; Jabeen Hussein: School of Den-
tistry, University of Western Ontario, London, ON.
Address reprint requests to: Dr. Leslie C. Dort, 2716 7th Avenue
NW, Calgary, AB T2N 1A7.
tion are conservative interventions that may help SDB.
CPAP, the gold standard treatment, splints the airway
open by delivering air under varying pressure through
a nasal or full-face mask. Although extremely effective,
CPAP is not always tolerated owing to a variety of side
effects. The side effects of CPAP include rhinitis, con-
junctivitis, sinusitis, skin abrasions, and abdominal dis-
tention. CPAP compliance is limited, with 5 to 50% of
patients either refusing to begin therapy or discontinu-
ing in the first weeks and a further 12 to 25% discon-
tinuing therapy in the next 3 years.7
OAs have been considered as therapy for SDB
since 1934, when Pierre Robin devised an appliance for
use in micrognathic infants. The tongue-retaining
appliance first described by Cartwright and Samuelson
in 19828 is presently prescribed for use with very little
design modification.,9 Over the past 20 years, much of
the research involving appliances has focused on
designs that advance or protrude the mandible.10,11
Evidence of OA efficacy has been supported, in
recent years, by the results of randomized controlled tri-
als. The definition of success has customarily been
defined as a reduction of the Respiratory Disturbance

172
 Dort and Hussein, Oral Appliance Therapy for Snoring and Obstructive Sleep Apnea
Index (RDI) to 10 events per hour and a 50% reduction
in RDI. Effectiveness in clinical trials to date shows that
OAs can treat mild OSA with approximately 75% suc-
cess.1215 Success decreases to approximately 50% when
patients have moderate or severe OSA.16,17 Common
side effects with OAs include excessive saliva, minor
tooth movement, and tender masticatory muscles, teeth,
and temporomandibular joint (TMJ) structures. The
side effects of OAs are usually reversible once therapy is
discontinued.18 The exception in OA therapy is move-
ment of the teeth, which may require orthodontic inter-
vention to reverse it if desired.
OAs are currently recommended as appropriate
first-line therapy for mild to moderate SDB19 and as
second-line therapy for severely affected patients when
CPAP is not tolerated or successful. In current clinical
practice, a dentist may use one or two appliances in
selected patients for mild to moderate OSA. Recent
randomized trials have also indicated success in treat-
ing more severe patients.12,20 The results of these and
future trials could change the recommendations for
appliance therapy.21
Surgical reduction of the soft palate and related
tissues by conventional or laser methods have a lim-
ited role in treating primary snoring. Four-year follow-
up of a randomized trial comparing the success of uvu-
lopalatopharyngoplasty (UPPP) with OA therapy showed
UPPP to have a 40% success rate compared with 80%
for OA.22 A recent randomized controlled trial of laser-
assisted uvulopalatoplasty demonstrated a reduction of
apnea hypopnea index (AHI) to 10 or less in 24% of sub-
jects with minor improvement in symptoms.23
CPAP compliance can be covertly monitored by
recordings of machine time use, which patients are
unable to alter. This gives an accurate account of how
many hours the machine was in use without any dis-
pute. There are promising investigations into covert
compliance monitors for OAs; however, there are
presently no commercially covert compliance monitors
available. Patient self-report of appliance use is the best
alternative.11
Previous compliance reports in the literature have
focused on compliance related to particular
appliances.11,22,24,25 Thus, the objective of this investi-
gation was to obtain an estimate of the effectiveness of
different types of OAs in a clinical setting through a
questionnaire targeting appliance use and the side
effects of a variety of OAs.
It is estimated that over 90% of those with OSA
are undiagnosed.26 As recognition and diagnosis of
OSA increase, so will the demand for appliance therapy
both as a first-line therapy and for second-line therapy
for those who have failed surgery or CPAP. The out-
comes of this analysis show that compliance with a
variety of appliances in a wide range of patients is com-
parable to compliance with CPAP.
173
Materials and Methods
Detailed questionnaires regarding patient use of appli-
ances were mailed to 115 patients who had received
one of eight OAs from the Foothills Hospital Dental
Clinic and who were a minimum of 4 months post-
titration. To encourage frank responses, subjects who
did not reply by mail or fax were contacted by tele-
phone by a research assistant, not the clinician who fit-
ted the appliances. The survey was not an alternative
to regularly scheduled follow-up but an addition to
follow-up. All patients who receive appliances at the
clinic have regularly scheduled follow-up visits, the
number of which varies with the appliance type. There
is no additional fee for the follow-up visits to encour-
age attendance and to maximize the possibility of
addressing concerns and increasing compliance.
The range of time since titration was 4 to 48 months.
The titration point varied depending on whether the
appliance was adjustable or nonadjustable. If the appli-
ance was adjustable, then titration was considered to be
when the appliance had been advanced to its most effec-
tive position as determined by the patients symptom
relief and a follow-up sleep study. If the appliance was
nonadjustable, then titration was considered to be when
the appliance was reportedly worn for a minimum of
4 hours each night. Table 1 describes the baseline charac-
teristics of the subject group. The mean initial RDI was
28.1 24.9; the median RDI was 20, with 75% of sub-
jects having an initial RDI of less than 35 events per
hour. The initial RDI was not available for one subject.
Patients were not selected by disease severity or
prior history. The survey recipients included patients
with mild, moderate, and severe SDB and patients who
had failed other treatments, such as CPAP and surgery.
Results
Responses were obtained from 77 subjects. Five sur-
veys were returned because of address changes, and
these were not included in the analysis. The overall
response rate was 77 of 110 (70%). Subjects were cate-
gorized as nonresponders (NRs) if they did not return
the survey. Those who answered the survey were
grouped as noncompliant responders (NCRs) if they
reported that they were not using the appliance and as
compliant responders (CRs) if they were still using the
Table 1 Survey Recipients Baseline Characteristics
Characteristic n Mean SD Median
Initial RDI 76 28.1 24.9 20
Follow-up interval (mo) 108 21.0 11.9 24
Females 28
Males 87
RDI = Respiratory Disturbance Index.
174 The Journal of Otolaryngology, Volume 33, Number 3, 2004
appliance. The data from the three groups were analyzed
with regard to male-to-female distribution, follow-up
time, appliance type, initial RDI, side effects, sleepi-
ness, and reported effect on snoring. When three
groups, NRs, CRs, and NCRs, were compared, a one-
way analysis of variance was applied. Two groups
were compared using unpaired, two-tailed, t-tests. A
value of p < .05 was considered significant.
The number of responders who were still using
their appliances was 44 (57%). If it is assumed that the
NRs were noncompliant, then the compliance rate
drops to 44 of 110 (40%). This is not necessarily a
valid assumption because several of the NRs have
returned to the clinic for follow-up and are still wear-
ing their appliances.
The mean follow-up time of the CR group,
18.10 + 2.03 months, was not significantly less
(p = .05) than the NR or NCR groups, 22.91 + 1.90
and 21.77 + 2.05 months, respectively. There were no
significant differences in the male-to-female distribu-
tion of the groups (p = .927). The initial RDIs of the
three groups were comparable (p = .6741). All three
groups had significant changes to the mean RDIs after
treatment. CRs reported using their appliance at least
80% of the night for a minimum of 4 nights per week.
Forty-three percent of the CR group reported being
very satisfied, and 48% reported moderate satisfaction.
Nine percent continued to wear the appliance while
reporting moderate dissatisfaction with the treatment.
Respondents were asked to report side effects as
either those that were nuisance effects or those that
resulted in discontinuing treatment. Excessive saliva-
tion was the most common nuisance side effect and
was reported by 60% of subjects. Muscle and jaw pain
was the side effect that most frequently resulted in dis-
continuing use. The NCR group reported various con-
cerns with appliance fit, comfort, and design, none of
which were limited to a particular appliance. CRs
reported much more control of snoring and excessive
daytime sleepiness, but no single outcome criterion was
a determinant of compliance. CRs reported 50% con-
trol of sleepiness compared with 18% of NCRs
(Figure 1). Seventy-one percent of the CR group con-
sidered their snoring to be controlled compared with
18% of the NCR group (Figure 2).
Table 2 shows the compliance by SDB severity of
those who responded to the survey. There is no evi-
dence that subjects with more severe disease are less
compliant (less likely to use the device).
Discussion
Compliance rates reported by patients in this study
ranged from 40 to 57% and are slightly less than those
reported by some investigators.27 This compliance rate
may reflect a clinical practice not limited in appliance
% of Responders
50
40
30
20
10
0
Totally Satis. Not Satis. No Change
Controlled Controlled Controlled
Sleepiness
CR NCR
Figure 1 Comparison of sleepiness control for compliant
(CR) versus noncompliant (NCR) responders.
selection or patient selection by clinical trial design. A
variety of appliances can treat a wide range of SDB
problems; however, no one appliance was outstanding
in compliance outcome. Clinicians can be encouraged
to use a variety of appliances chosen to suit individual
patient needs and means. It can be expected that 50%
of patients will continue to use an appliance satisfacto-
rily after the fitting and accommodation period.
OA therapy outcomes in this analysis compare
favourably with CPAP, the gold standard therapy,
when compliance is the outcome under consideration.
In our analysis, we are not assessing the efficacy of the
appliances but the compliance. The question was not
do the appliances work but do the patients use them.
The use of eight appliances in this analysis reflects
a clinical practice that not only provides OA therapy as
a first choice for mild and moderate OSA but also pro-
vides appliance therapy for a wide range of OSA
patients who fail to improve after surgery or with
CPAP or who are intolerant of CPAP. Patients present
with a wide range of conditions, which limits use of
particular appliances. Edentulism, partial edentulism,
allergies, material sensitivities, the presence of a strong
gag reflex, and TMJ limitations or dysfunction are con-
ditions that can influence appliance choice. The align-
ment of the dentition and a history of bruxism or past
appliance use will also influence appliance choice.
Patients may not wish to have any portion protrude
from the mouth or may not want any portion of an
appliance in the palatal region.
% of Responders
60
50
40
30
20
10
0
Totally Satis. Not Satis. No Change
Controlled Controlled Controlled
Snoring Control
CR NCR
Figure 2 Comparison of snoring control for compliant (CR)
versus noncompliant (NCR) responders.
 Dort and Hussein, Oral Appliance Therapy for Snoring and Obstructive Sleep Apnea
Table 2 Compliance by Severity of Sleep-Disordered
Breathing
Initial RDI No. No. of Compliant Proportion
(events/h) Surveyed Responses Responders Compliant
< 15 28 19 11 11/19
15 to < 30 22 16 7 7/16
> 30 26 18 11 11/18
Pearson chi-square = 1.15; p = .56.
The analysis includes the results from prefabri-
cated or boil and bite appliances and custom-made
appliances. Although not as effective as custom appli-
ances, noncustomized appliances allow access to ther-
apy for those with financial limitations or those who
are skeptical about therapy owing to past failures.
This is a large group of patients. Physicians diagnos-
ing OSA wish to have an estimate of how appliance
therapy may apply to all possible patients. Patients
must be very well informed as to the limitations of
noncustomized appliances. Failure with a noncus-
tomized appliance does not necessarily indicate that a
customized, adjustable appliance would be unsuccess-
ful. Patients must be well informed so that they do
not miss an opportunity to be effectively treated by a
custom appliance.
Control of sleepiness and control of snoring were
significant indicators of compliance. These results sup-
port those of other investigators in the conclusion that
quality of life is the most significant outcome for deter-
mining the effectiveness of treatment for SDB. Patients
may continue to be compliant when snoring is not con-
trolled but sleepiness is and vice versa. Partner satisfac-
tion cannot overcome significant side effects, such as
muscle pain. The side effects of jaw, tooth, and muscle
pain limit appliance use.
As the population of patients diagnosed with SDB
increases, so does the growing need for appropriate
treatment, such as appliances that patients can wear
effectively and comfortably. At present, a number of
well-investigated, effective appliances are available to
the clinician. Unfortunately, a significant group of
patients who cannot wear these appliances effectively
remains. Follow-up of patients fitted with appliances is
essential. Even those patients whose follow-up sleep
tests show them to be effectively treated may discon-
tinue wearing them. These patients are at risk of the
morbidity associated with SDB. Those who are not
compliant with a prescribed treatment should be
encouraged to investigate alternative therapy.
This study had several limitations. The number of
subjects using any one appliance was small. Future
follow-up investigations are needed to confirm our
results. Patient self-report is known to be inaccurate.
When covert compliance becomes possible, a more
accurate compliance study can be undertaken.
175
Appliances can be considered in conjunction with
other modes of therapy. With appropriate follow-up,
appliances can be used in conjunction with CPAP for
occasional or alternating use. Further studies need to
be done to investigate the combination of therapies for
improved overall compliance.
The use of appliances by patients is comparable to
those using CPAP. OAs are a reasonable therapeutic
alternative to consider in the increasing patient popula-
tion diagnosed with SDB.
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