IRISH
SLEEP SOCIETY GUIDELINES 2007 – Final Draft
Section
1. Respiratory Obstructive Sleep Apnoea
Guidelines:
Definition:
Obstructive Sleep Apnoea
Syndrome (OSAS) is a complex disorder
characterised by brief interruptions of
breathing during sleep. Airflow into and out
of the lungs is reduced or diminished due to
closure of the upper airway, despite
continued respiratory effort. The most
common presenting symptoms are excessive
daytime sleepiness, loud snoring and
witnessed apnoeas. The condition is
diagnosed by an objective measure of
abnormal nocturnal respiration coupled with
a compatible clinical picture.
Pathophysiology of OSAS:
This condition is
characterised by intermittent upper airway
obstruction during sleep due to multiple
factors, including physical narrowing of the
upper airway, muscle fatigue of the upper
airway muscles and/or a neurochemical
imbalance of respiratory drive. These events
are associated with recurring episodes of
arterial oxygen desaturation. Apnoeas are
typically terminated by a brief
micro-arousal resulting in sleep
fragmentation and diminished amounts of
show-wave and REM sleep. These mechanisms
have been reviewed in detail by White et all
(Pathogensis of obstructive and central
sleep apnoea. AM J Respir Crit Care Med.
2005 Dec 1;172(11):1363-70. Epub 2005 Aug 11
Epidemiology:
No data are available at
present on the prevalence of OSAS in the
Irish population, but international data
indicate that 2-4% of the middle aged adult
population have OSAS. These data indicate
that there could be up to 50,000 sufferers
in Ireland at present. ISS recommends that
research be conducted in this area as soon
as possible to more accurately determine the
extent of this syndrome in the Irish
population.
Symptoms and Clinical Features of OSAS:
The following symptoms
are associated with OSAS, but may not all be
present in each patient.
Table 1 Major Symptoms and Clinical Features
associated with OSAS
Daytime Symptoms
|
|
Asymptomatic |
|
Excessive daytime
sleepiness (EDS more likely to be
reported by men) |
|
Fatigue (this is
more likely to be reported by women |
|
Neurocognitive
dysfunction |
|
Personality
changes |
Night-time Symptoms
|
|
Snoring (often
loud) / Snorting |
|
Witnessed apnoea |
|
Fragmented/restless sleep |
|
Nocturia |
|
Night time
Sweating |
|
Nightmares/unpleasant dreams
|
|
Recurrent
arousals |
|
Morning
headache/respiratory failure |
Clinical Features
|
|
Narrowed upper
airway |
|
Systemic
hypertension |
|
Cardiac
arrythmias |
Risk Factors for development of OSAS:
Obesity, in association
with increased neck circumference (³17”)
Upper airway abnormality
– Nose, Tongue, Jaw, Pharynx, Larynx
Endocrine disorders
including Acromegaly, Non insulin-dependent
Diabetes Mellitus (NIDDM), Hypothyroidism
Cardiovascular disease,
especially systemic hypertension
Post menopausal state
(females)
Consequences for non-treated OSAS:
Hypertension
Cardiovascular disease
Stroke
Diabetes, poor diabetic
control
Sudden death
Road traffic accidents (RTA)
ISS Priority screening for OSAS:
Since OSAS can contribute
to RTA’s as well as contributing to long
term poor health ISS recommends that the
following categories of patients be
considered for screening for OSAS:
Persons reporting RTA due
to sleepiness
Commercial drivers
Diabetics, type II in
particular
Clear-cut upper airway
abnormalities (very large tonsils,
significant retrognathia in whom upper
airway surgery is being considered)
Neuromuscular disorders
(at risk of nocturnal hypoventilation)
COPD (FEV1 <1.5l)
Unexplained
Cardiomyopathy/Stroke/Cardiovascular disease
Such screening should
initially be based on a detailed history and
examination and, if supportive clinical
features are present, an overnight sleep
study is indicated.
Assessment of daytime sleepiness:
Excessive daytime
sleepiness (EDS) is one of the most common
symptoms of OSAS, but it can also be
associated with other medical conditions. In
the context of OSAS, ISS recommends that
the Epworth Sleepiness Scale (ESS) be
routinely used to assess the patient’s
subjective perception of daytime sleepiness.
The ESS is a subjective
questionnaire, which scales the patient’s
perception of daytime sleepiness between
0-24. It asks the patient to number
appropriately the likelihood of falling
asleep in certain daily situations. Some of
these situations are very passive, (i.e.
lying down, watching TV), others are very
active (i.e. driving, conversation).
More objective measures,
such as the Maintenance of Wakefulness
Testing (MWT) can be considered when OSAS
has been eliminated. The ISS recommend that
the ESS be validated within the Irish
population and that further research be
undertaken to develop alternative low
intensity tools for assessing daytime
sleepiness
Diagnosis of OSAS:
To make a diagnosis of
OSAS a complete clinical assessment
including both history and physical
examination should be undertaken, looking in
particular at daytime sleepiness and coping
strategies for EDS, in addition to an
objective recording of nocturnal respiration
and other related variables. The ISS
recommends that the clinical assessment
should be comprehensive and include (as well
as the ESS) the following:
Clinical Examination
Measure of BMI (height
and weight)
Neck circumference
Mandible size
Nasal patency
Upper airway and oral
examination, including jaw and tongue
position when supine
Blood pressure
Cardiac and respiratory
examinations
Clinical Assessment
Investigations of the
patient’s primary reason for presentation to
the clinic (e.g. snoring, concern over
apnoea or effect o excessive sleepiness
In order to assess the
severity of sleepiness the lifestyle, sleep
and work routine, occupation, sleep
duration, exercise pattern as well as sleep
hygiene factors (shift work/sleep patterns)
should be investigated.
Factors such as
caffeine/alcohol/cigarette consumption and
drug use all of which contribute to weight
gain and poor sleep should be assessed.
Driving safety assessment
to include coping strategies at presentation
should be assessed. If there is a concern
about the subjects ability to drive, in
particular if they drive professionally then
there is an obligation by the Health Care
professional to advise the subject to avoid
driving and if they must drive then to be
aware of the need to pull over and sleep for
20 minutes or to take a caffeinated drink,
It is also the duty of the health care
professional to ensure that they arrange for
investigation and treatment as rapidly as
possible.
Past medical history
Family history,
especially of OSAS/other sleep
disorders/endocrine/cardiac diseases
Objective Recording of
Nocturnal Respiration
The objective assessment
of nocturnal respiration during an overnight
study must include as a minimum, oro-nasal
airflow, respiratory and abdominal effort,
and continuous oxygen saturation by pulse
oximetry. This type of study is referred to
as a limited sleep study or a multi-channel
respiratory recording with most proprietary
systems available also including clinically
relevant variables such as heart rate and
rhythm, body position and snoring noise.
ISS recommends that nasal
pressure is the Gold Standard method for
assessing airflow rather than oro nasal
thermister
However, the gold
standard overnight assessment is
Polysomnography (PSG), which incorporates
the above signals in conjunction with EEG
(electroencephalography), EOG (electrooculography),
and EMG (electromyography) to relate the
sleep/wake pattern with the respiration
signals..
The ISS recommends that a
full PSG be performed in all patients when
the limited study is negative for OSAS in
the presence of a high clinical suspicion.
PSG is also recommended for patients with
sleep related conditions such as narcolepsy,
and periodic limb movement disorder (PLMD).
ISS recommends that
attended in-hospital PSG study is the gold
standard. However, PSG set up with manual
analysis by trained personnel without full
overnight in-hospital supervision is
acceptable. Also Home-based limited studies
have become more available and are also
acceptable provided they are set up in the
sleep laboratory and analysed by trained
personnel. ISS recommends that a service
providing home-based limited sleep studies
should be integrally linked to a
full-service sleep laboratory.
However, ISS cannot make
a recommendation at this time on home-based
PSG studies.
Analysis and Scoring
of Overnight Sleep Studies:
ISS recommends that all
studies, both PSG and limited must be
manually scored and does not accept
automated reports. ISS recommends that the
Rechtshaffen and Kales (R&K) guidelines be
applied to the analysis of sleep staging in
PSG studies. ISS recommends that the
American Sleep Disorders Association (ASDA)
guidelines for arousals should be applied
during manual scoring. The ISS also
recommends the American Academy of Sleep
Medicine (AASM) severity grading criteria
for PSG studies, but advise caution when
applying these to limited sleep study
results.
Definitions of Apnoeas
& Hypopnoeas:
ISS recommend the
following definitions:
An obstructive apnoea
(cessation of breathing) in adults is
defined as a minimum 10 second reduction in
airflow to between 20-25% of the baseline
airflow volume, with paradoxical respiratory
effort. In children an apnoea can be < 10
seconds if the airflow reduction criteria is
met. An obstructive apnoea is usually
accompanied by a >3% oxygen desaturation
event.
An obstructive hypopnoea
(reduction in breathing) in Polysomnography
(PSG) studies is defined as a reduction of
50% in airflow signal AND an EEG
arousal, OR >3% oxygen desaturation.
In limited studies where
sleep and EEG arousals are not recorded an
obstructive hypopnoea is defined as a
reduction of 30% or more in airflow AND
>3% oxygen desaturation OR 50%
reduction in airflow without desaturations
in the presence of compatible clinical
symptoms.
The Apnoea/Hypopnoea
Index (AHI) is defined as the number of
apnoeas and hypopnoeas per hour of sleep (PSG)
or limited study, where the patient is
judged to be asleep (i.e. lack of movement).
Grading of sleep apnoea:
An apnoea/hypopnoea index of
5-15/hour is mild OSA. An apnoea/hypopnoea
index of 16-30/hour is moderate OSA and an
apnoea/hypopnoea of greater than 30
events/hour is considered severe OSA.
Treatment of OSAS:
The device is a quiet
pump, which blows air continuously through
the nose, via a well fitting nasal mask,
which is strapped to the patients nose. The
applied pressure can be adjusted to achieve
a positive pressure of between 4 to 20 cm H2O,
depending on the severity of the condition.
The consequences of upper airway collapse
disappear as soon as the effective positive
pressure is applied. Sleep architecture
improves, respiratory efforts decrease,
snoring is abolished, arterial blood oxygen
saturation is higher and pulse rate
stabilises. A large number of patients can
obtain substantial clinical improvement,
particularly with daytime somnolence using
this therapy. OSAS is prevented immediately
and continues for as long as the mask is
worn and CPAP pressure remains adequate
(optimal pressure) for the patient.
The optimal pressure, in
CPAP treatment, is defined as the lowest
pressure that eliminates different
respiratory events in all positions and
sleep stages, resulting in normalised sleep
architecture. Titration is the process of
making a trade-off, between eliminating all
obstructive events by increasing the
pressure, and reducing side effects by using
the lowest possible effective pressure.
Automatic titrating systems are such devices
and they are engineered to continuously
adjust the pressure at the “optimal” level.
They mainly use the pressure flow signals to
detect apnoea and hypopnoeas or flow
limitation.
However, the pressure
required to prevent upper airway collapse
varies considerably between patients and
cannot be predicted from clinical features
and /or disease severity. Thus, the
initiation of CPAP therapy is complex and
requires one or more titration studies to
determine the optimum pressure level for
each individual patient.
The Gold standard for
CPAP titration is manual titration during
PSG study. However, newer auto titrating
devices (APAP) have been developed that are
comparable with manually titrated studies.
To ensure that there has been an adequate
choice of pressure the ISS recommends
limited sleep studies or at the least
measurement of oximetry along with APAP be
performed, whether in Hospital or at home
ISS recommends where in
hospital formal assessment has taken place
with a supervised overnight titration on an
APAP device then it is acceptable to carry
out a clinical follow up in OPD. This follow
up should include an assessment of ESS,
compliance, and discussion of side effects.
ISS recommends where the
objective diagnosis has been established
with limited home-based sleep studies and
where APAP has also been performed at home
that patients should have a follow-up sleep
study to ensure efficacy of treatment, in
addition to the clinical assessment of ESS,
compliance, and discussion of side effects.
ISS strongly recommends
that initiation on CPAP must include a
detailed educational and mask fitting
session with trained clinical personnel.
This ideally should take place in the
hospital/sleep laboratory.
ISS recommends that there
be a limit to the role of the manufacturers
in the provision of these steps in
management as they are professional issues.
ISS recommends that the
HSE cover the cost of the device rental and
Mask/headgear in full to patients in receipt
of a medical card and that they be covered
as part of the drug refund scheme in all
other patients.
Oral appliance therapy
includes a range of
intra-oral
devices worn in the mouth at night. These
types of devices adjust the position of the
lower jaw bringing it forward thereby
increasing
the diameter of the pharynx in the upper
airway reducing the potential for
obstruction to develop. They are also called
Mandibular Advancement Devices.
There are two main
categories of oral appliances one is the
“Monobloc” type which are one part fixed
appliances and the other group are “Titratable”,
which are one to two part adjustable
appliances. The appliance can also be used
on a provisional basis (interim /diagnostic)
or definitive (long-term basis). Liaison
with dental laboratory professionals to
optimise the provision of mandibular
advancement appliance services is essential
whether provisional or definitive in
nature. Customisation of appliances is
necessary to meet specific individual
anatomical and treatment requirements.
Provision of a removable intra-oral device
is only recommended after consultation and a
complete sleep assessment.
ISS recommend that AASM
guidelines for mandibular advancement
devices be applied.
ISS recommend that the
Dentists role in screening patients who
present for Oral devices but who have not
been screened by other Physicians/Surgeons
should include:
1.
The use of health questionnaires,
including the Epworth Sleepiness Scale to
determine the degree of excessive daytime
sleepiness.
-
Also a medical
history should be taken to elicit
possible conditions, which may be
associated with OSAS e.g. hypertension,
stroke, heart attack, acid reflux
(GERD), diabetes and recent weight gain.
-
Where positive
responses to the data elicited from
these health questionnaires/ medical
history is found ISS recommend that the
patient should be referred to the
relevant Sleep Physician for
investigation and diagnosis of possible
OSAS or / other sleep disorders.
Role of the Dentist when
the patient is referred from Sleep
Physician/Surgeon:
Angle Classification of
skeletal jaw form.
Additional special tests that can be carried
out include:
Casts of upper and lower
arches
Orthopantomograph (OPG)
and standard periapical radiographs where
necessary.
Trial advancement bite
registration test
ISS recommend that
after the appliance has been fitted that
evaluation of treatment in terms of
appliance efficacy and tolerance must be
conducted by the dentist. This evaluation
should include:
Ongoing monitoring of
appliance fit and comfort at specified
intervals
Subjective evaluation of
efficacy garnered from bed-partners response
and post treatment Epworth Sleepiness Scale.
Schedule a return visit
to the referring physician so that an
objective efficacy test follow-up through
either polysomography or limited sleep
studies, depending on which study was
performed to reach a diagnosis, can be
performed.
In addition, evaluation
and documentation of treatment planning
decisions and any subsequent modifications
in association with other medical
professionals is also necessary.
Sundaram et al, 2005).
However, the following number of surgical
options including tonsillectomy,
adenoidectomy, septoplasty, turbinate
reduction and removal of nasal polyps have
been shown to improve the nasal airway
leading to an increased efficacy and
tolerance of CPAP. Other surgical procedures
include reconstruction surgery, UPPP,
Genioglossus tongue advancement, mandibular
osteotomy etc. However these surgical
options are only of value in carefully
selected patients. Therefore ISS recommend
that a multidisciplinary approach is adopted
to ensure the surgical value in carefully
selected patients.
ISS also suggest that RCT
studies are performed to evaluate accurately
ENT surgical outcome.
NT
Assessment to include
ISS recommend that the
ENT surgeon’s role in screening patients who
present for ENT surgery for snoring or
suspected OSAS should include:
Clinical Examination
that assesses the following (when
available):
Body Mass Index & neck
circumference
Nasal obstruction
Oral cavity & Oropharynx
Freidman tonsil score
(Appendix 1)
Mallampati score of
pharyngeal congestion (Appendix 1)
Nasopharyngoscopy /
Mueller Manoeuvre
Acoustic Rhinomanometry
Sleep Nasendoscopy
Sleep Nasendoscopy can
help to identify
the level i.e. Soft Palate, Tongue Base or
Larynx, of the obstruction.lThis
procedure was first described by Croft and
Pringle in 1991. The patient is sedated
until snoring is achieved. The procedure
allows visualisation of the vibrating
structures and the site & extent of upper
airway collapse. A
Classification system was
developed in 1993 and was further modified
in 1995.
However, it is unlikely
sedation-induced sleep correlates well with
natural sleep and currently no standardised
sedation protocol and so the true efficacy
of this procedure is still debated.
Clinical Assessment to
include (not all radiography options readily
available):
Epworth Sleepiness Scale
Snoring
Symptoms Inventory
Partner VAS / Partner
Questionnaire
Snore box / Sleep studies
Acoustic Analysis / Snore
Sound Characteristics
Radiography –
Cephalometry, Somnofluoroscopy, CT, MRI
Definition
Restless Leg Syndrome (RLS) is a complex
lifelong sensorimotor disorder. Patients
experience an intense, disagreeable creeping
sensation in the lower extremities,
especially in the evenings, which is
relieved by moving the legs. There are both
a primary and secondary form of RLS.
Periodic Leg
Movement Disorder (PLMD) is
characterised by
repetitive leg movements during non -REM
sleep, most commonly the extension of big
toe, dorsiflexion of ankle, or knee, or hip
every 20-40 seconds.
PLM’s may cause
EEG arousals, which reduce sleep quality and
results in excessive daytime sleepiness.
PLM’s are noted in at least 80% patients
with RLS. As a result the occurrence of both
waking and sleeping periodic leg movements
PLMD is now recognized as opposed to pure
sleep associated PLMs.
Primary and secondary forms of RLS & PLMD
The same constellation of symptoms may occur
in the setting of several disorders and
physiologic changes, notably iron deficient
anaemia, pregnancy and polyneuropathy. This
has led to the term “secondary” RLS. A
positive family history is a defining, but
not mandatory, feature of the primary form
of RLS.
Primary form
Positive family history
“Secondary” form
Peripheral neuropathy
Uraemia with anemia
Iron deficiency anaemia
Pregnancy
Also thyroid disease, drugs,
myelopathy, varicose veins
Population-Based
Studies
In population based studies of 157 to 2019
individuals, the prevalence for RLS ranges
from 0.6% to 15%. A recent study of 606
pregnant females, mean age 31.8 years, found
a 27% prevalence of RLS. In 10% symptoms of
RLS were already present, while in 17% they
were limited to the duration of pregnancy
(the role of iron deficiency is relevant
here). PLM ‘s can occur at any age, but are
more noticeable in the older generation.
Differential diagnosis
Peripheral neuropathy
Lumbosacral radiculopathy
Hypnogenic myoclonus (sleep starts)
Nocturnal leg cramps
Venous/arterial
insufficiency
“Painful legs and moving
toes syndrome”
“Growing pains”
Akathisia
Diagnosis of RLS &
PLMD
The clinical history and
otherwise normal examination are generally
sufficient to make a diagnosis of RLS. But
objective measures can be used also.
Actigraphy measures the surrogate marker PLM
and is extensively used in therapeutic
research. Polysomnography can measure leg
PLM activity overnight during a sleep study
recording. ISS recommend that bilateral leg
EMG should be measured if PSG is be used to
diagnose the presence of PLMD.
Carry out FBC,
creatinine, glucose, ferritin, folate, B12,
to check for iron
deficiency, uraemia.
Diagnostic criteria based on clinical
assessment
The urge to move legs, with unpleasant
sensations (legs)
An increase or
onset of symptoms with rest or inactivity
Decreased symptoms
on movement, eg, stretching
An increase in symptoms
during the evening and night
A variable course of symptoms
A normal physical examination in idiopathic
RLS
Complaint of sleep disturbance
Supportive clinical features
A response to dopaminergic therapy
Objective evidence of periodic leg movements
during wakefulness or sleep
Therapeutic guidelines.
The available agents have been reviewed and
rated by the RLS Task Force 2004 Standards
of Practice Committee of the American
Association of Sleep Medicine (AASM)
Overall Management
Provide education and
support to patients diagnosed
Limit therapy to patients
with sleep disturbances and consider age,
severity, and motivation for treatment
Treat anaemia if present
Use dopamine agonist for
any stage of RLS — mild, moderate, and
severe
Problems with l-dopa
Loss of efficacy over time
Rebound phenomenon - Recurrence of symptoms
later in the night or in the early morning
after the initial response
Augmentation
Symptoms earlier in the day, with an
increased intensity and extension to other
regions
82% of patients on l-dopa
develop augmentation
Dopamine agonists
Theoretical advantages:
longer elimination half-life (EHL) with
reduced tendency to rebound and
augmentation.
Pergolide
(Celance)
0.5 mg 2 hr before bed; EHL 27 hr
Reduced PLMS with arousal (2.3 / 8.9), RLS
decreased
No change in total arousals, or REM, but
sleep time increased
Nausea, headache, rhinitis, vomiting,
abdominal pain, dizziness
Augmentation 15 – 27%
Valvulopathy (Baseman et al) has emerged as
a significant risk; ergot toxicity.
Pramipexol(Mirapexin)
0.75 - 1.5 mg (salt weight) 1 hr before
bed; EHL 8 hr
98 % decrease in PLMS
84% decrease in RLS
Total sleep time, number of awakenings and
sleep efficiency, unchanged
REM suppressed
Nausea, fatigue, dose related
Augmentation 8.5 – 18%
Pharmacological
Treatment: sequential trials
First-line pharmacological
treatment
Dopamine agonists (EHL hr
in parentheses)
·
Pramipexole
(8) , cabergoline (65), ropinirole (6),
pergolide (27)
dose decrease or change
for augmentation
·
L-dopa/DDI
(100/25 mg - 400/100 mg)
Typically recommended
only for mild symptoms
PRN use; short half-life
Second-line pharmacological
treatments
·
Benzodiazepines, opioids, anticonvulsants
·
Add
Clonazepam as needed for sleep - watch for
exacerbation of OSAS
·
Empiric iron therapy not
justified unless ferritin <50mcg/l
|