The Irish Sleep Society - Cumann Codhladh na hÉireann.  Officially established on 24th September 2005

   

 

 
Google
 
       

Add this page to your favourites

 
Home Contact Us Site Map

Menu
News
News Alerts
About Us
ISS guidelines
Membership
Meetings
Links ISS
Newsletter
 

Up

 

 

 

 

 


 
 

 

 

 

ISS guidelines

Irish Sleep Society Guidelines...
 

 Draft ISS Guidelines

Draft ISS guidelines for the diagnosis and management of sleep disorders in Ireland.

 

Attention ISS members ONLY.

We ask members only to review the draft guidelines and submit any comments or suggestions for change that you may have.

An immediate response would be most welcome please.  Please use the facility below for such submissions.

The executive committee will require time in advance of the AGM to collate all comments /suggestions so that discussion on them can be managed efficiently at the meeting.

 

 

 Download Draft ISS Guidelines for review...

Available for download in Microsoft Word and Adobe Pdf formats

 

ISS-Draft-Guidelines-Oct-2007
 
 
ISS-Draft-Guidelines-Oct-2007

You will need either Microsoft©®™ Word viewer or Adobe©®™ Reader to download view and print the document, unless you have Microsoft Word or Adobe Acrobat on your computer.

 

 Comments/Suggestions Draft ISS Guidelines

Please  to submit your comments/suggestions/remarks.

 

 
 
 

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:

Depending on the severity of the symptoms and the OSAS there are a number of options available for treatment. Generally weight reduction, alcohol and sedative avoidance, and sleep hygiene measures are recommended for all patients including the avoidance of the supine position. In some patients a decision will be made to choose no other specific therapy. Three main options of therapy are currently available. These include, CPAP (continuous positive airway pressure), ENT surgery, or mandibular advancement devices.

The ISS recommends that the clinical circumstances and the patient’s own preference be involved in the major decision process for choosing any of the options above.

In general, for moderate to severe OSAS, CPAP is the first-line treatment of choice.

Mandibular advancement devices are not recommended as first line treatment for moderate to severe OSAS, but can be offered in mild OSAS or where CPAP treatment has failed due to non tolerance/compliance (see section 2 for more information.). Mandibular advancement devices can be effective in non apnoeic/simple snorers.  

ENT surgery may improve CPAP tolerance where nasal obstruction is surgically possible, but is not considered a first line treatment for OSAS (see section 3 for more information). 

 

CPAP Therapy

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.

 

  

Section 2. Dental Oral Appliance Therapy Guidelines

Definition:

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.

The objectives of oral appliance therapy are to provide effective appliance therapy for suitable patients because appliance therapy can only be provided in the absence of dental pathology, oral pathology, jaw dysfunction and anatomical anomalies and in the presence of adequate retention for appliances e.g. teeth, dental implants. Literature has also demonstrated that oral devices can be considered as first-line treatment for snoring and mild OSAS, but they are not recommended for moderate to severe OSAS patients, however they can be used in cases where these patients are not tolerant of CPAP and so would otherwise not receive any treatment. In a significant number of these CPAP intolerant cases adequate reduction in the AHI is seen. Subjective assessment of patients with a snoring problem wearing these appliances show satisfactory snoring management in approximately 95% of these cases and thus they should be considered as a very suitable solution for non apnoeic snorers. 

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.  

Role of Dentists in Screening Patients for OSAS/other sleep disorders:

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.

  1. 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.
  2. 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:

When a relevant medical professional refers a patient to the dentist for evaluation of the suitability of a patient to receive an oral appliance, ISS recommends that a complete extra-oral and intra-oral examination is required to determine the absence of pathology or significant anatomical or physiological anomalies in the stomognathic system.

 

Patient Examination should involve documentation of the following parameters:

Oral or dental pathology

Jaw Function to include line of movement, range of movement and muscle palpation for evidence of spasm of dyskinesisa.

Temporomandibular joint anomalies 

Gag reflex

Static and dynamic occlusal evaluation of the dental arches

Tongue size anomalies

Throat form anomalies

Siebert Classification

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.  

 

Section 3 ENT Surgical Guidelines

The evidence to date in the literature does not support the widespread use of surgical interventions in the management of unselected patients with OSAS (

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

 

Role of ENT in Screening Patients for Snoring/OSAS/other sleep disorders:

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

 

OSA patients undergoing surgery will require extra care during recovery and where possible they should be encouraged to use their CPAP device.

 

Section 4. Restless Leg Syndrome & Periodic Leg Movement Disorder Guidelines

 

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

 

 

Section 5. Assessment and Management of Insomnia Guidelines 

Definition

Insomnia is a symptom, not a condition. Classification systems exist but no single system is agreed or clinically useful in common practice. It refers to difficulty in initiating or maintaining adequate sleep, or non-restorative sleep.

Transient insomnia is usually related to circumstances and ubiquitous. However, up to 80% of insomnia is chronic, lasting greater than 3 months. Most insomnia is secondary to or co-morbid with medical and psychiatric conditions and/or substance misuse. Drugs associated with causation of insomnia include alcohol, caffeine, tobacco, ecstasy, cocaine, amphetamines, theophylline, antidepressants, attention deficit disorder drugs, clonidine, propranolol, atenolol, albuterol, salmeterol, methyldopa, levodopa, quinidine, Corticosteroids, oral contraceptives, progesterone, thyroxine, phenytoin, amphetamines, decongestants, weight loss products, and pain relievers containing caffeine.

Chronic insomnia also occurs as primary idiopathic insomnia, psychophysiologic arousal or a manifestation of uncommon primary sleep disorders, e.g. restless legs syndrome and circadian rhythm disturbances in less than 20% of cases.  

One third of insomnia symptoms are associated with a mental disorder. It is an independent risk factor for development of depression and an increased risk of its recurrence and chronic course. It is associated with difficulties and accidents at work and more absenteeism. Insomnia is also associated with an impaired quality of life, daytime psycho-motor impairment, heart disease, immune dysfunction, and several endocrine and metabolic derangements.

 

Epidemiology:

While estimates vary approximately 10% -15 % of the general population report major current insomnia. 5% of primary care patients seek treatment for their insomnia. Recognition of the problem is poor. Women are consistently more likely than men to have insomnia, pregnancy or menopause are frequent triggers.

Increased age, separated, divorced, or widowed status is a population risk factor.

The elderly pattern of early bedtimes, sleep fragmentation at night, and daytime napping is not a form of pathological insomnia but a common focus of complaint.

 

Assessment of Insomnia
Screening for insomnia is indicated in routine health examinations. Detailed screening for associated co-morbid psychiatric conditions is of proven value. Insomnia may be co-morbid with a number of psychiatric conditions, mood disorders, anxiety disorders including nocturnal panic, or a history of drug or alcohol use. 

ISS recommend that full physical and mental state examinations along with a full sleep history are required when insomnia is complained of.

 

Diagnostic tools:

Sleep diaries are useful. Give the patient a sleep diary and ask that it be completed daily after awakening in the morning for 2 weeks. Ask for recording of bedtime, total sleep time, time it took to fall asleep, the number of times awakening at night, use of sleep medications, time out of bed in the morning, and a rating of subjective sleep quality and daytime symptoms. A sample sleep diary is also available at http://www.nhlbi.nih.gov/health/prof/sleep/insom_pc.htm. Collateral history from a bed partner is often valuable but not always confirmatory. Characteristic and associated factors should be identified, and screening questions should be asked regarding:

 

Current medication use

Pain

Gastro-oesophageal reflux disease

Nocturnia, prostate disease

Dementia

Hyperthyroidism

Parkinson’s disease

Restless leg syndrome or Periodic limb movement disorder

Narcolepsy

Snoring and other symptoms of sleep apnoea or respiratory insufficiency

 

Other investigations

Polysomnography or Multiple sleep latency tests are not indicated for insomnia evaluation. There is little evidence of the routine benefit of portable sleep studies or actigraphy either. Additional psycho-physiological measures (other than history taking of constitutional heightened arousal), however useful are mostly unavailable. 

 

Treatment of Insomnia:

Decrease the overall level of physiologic and emotional arousal, and not just to improve the night-time sleep. Correcting common faulty beliefs and expectations is essential. Addressing unrealistic sleep expectations, misconceptions, performance anxiety before sleep is helpful. Correction or alleviation of underlying causes of insomnia is essential where possible. Medication is most commonly used to treat insomnia while behavioural therapies are often not adequately tried.

Short-term pharmacological interventions (when kept short) are legitimate but are both frequently inappropriately withheld or overused.

In the intermediate term (i.e. 3-8 weeks), meta-analysis indicates that behavioural treatment for insomnia is just as effective as medication treatment.

Over the long term (i.e. 6-24 months), patients receiving non-pharmacological therapies enjoy long lasting relief while many of those treated with medication return to their baseline insomnia levels.

 

Non Pharmacologic Options:

The American Academy of Sleep Medicine recommends stimulus control as the approach with the best scientific evidence for effectiveness. It is simple and low in cost.

Stimulus control treatment consists of the behavioural instructions of: going to bed only when sleepy, using the bed and bedroom only for sleep and sex, whenever one is unable to fall asleep after 15-20 minutes, getting out of bed and going into another room and only returning when sleepy, get up at the same time every morning regardless of the quality of sleep during the night not taking naps during the day, and at a light bedtime snack.

 

Progressive muscle relaxation, paradoxical intention, and biofeedback effective while sleep restriction and cognitive behavioural therapy are recommended as options.

Sleep hygiene instruction is not evidenced as effective alone but may be as a component of other measures. Exercise in the 60+ age group (which increases body temp) resulted in better sleep quality, duration and onset latency. Cochrane review 2004. In spite of being popular, use of relaxation does not predict improvement.

 

Pharmacologic Principles:

Patients should be advised when treatment is started that it will be of limited duration (between 2 and 4 weeks) at the lowest effective dose. Prescribers should explain when the dosage is progressively decreased or stopped the likelihood of transient rebound or persisting insomnia exists and is not an indication for continuance. If medication use is to be extended it should be for documented and proportionate reasons. If use is extended, medication should be taken discontinuously (drug free intervals) wherever possible.

 

Over the counter insomnia treatments

The rationale for choosing OTC sleep aids includes readily availability, low cost, and favourable perceptions of safety or naturalness. Antihistamine based compounds are commonly used, however because of changes in sleep architecture, notably a reduction in rapid REM sleep caused by anti-cholinergic effects, a reduction in cognitive function, day time sedation, and increased risk of accidents, development of tolerance, and interference with medication, are not therefore not recommended or only for limited term use by ISS.

As robust data does not exist to support the hypnotic effect and safety of acute treatment of herbal extracts of Valerian on patients suffering insomnia and as paradoxical reactions and hepatotoxicity have been described ISS do not recommend this medication.  ISS do not recommend Melatonin or Kava based preparations as neither are evidenced as effective or safe.

 

Prescribed agents licensed as hypnotics

Licensed hypnotics include benzodiazepines, cyclopyrrolones, imidazopyridines and pyrazolopyrimidines

The choice of benzodiazepine (and dose) depends on the type of sleep disorder: Long term use with these agents is not well supported by trial data, and tolerance is commonly reported, so their continuous use offends good prescribing principles.

Cyclopyrrolones, imidazopyridines and pyrazolopyrimidines act on the benzodiazepine receptor and are short acting, with fewer propensities to daytime sedation, cognitive impairment, dependence and rebound insomnia, but are occasionally abused.

Patients who have difficulty in falling asleep can be treated effectively with short or intermediate-acting hypnotic.

Patients experiencing situational insomnia or periods of wakefulness during the night, or early awakening, need a hypnotic with an intermediate half-life, or alternately a short acting hypnotic taken during the night.

Long-acting hypnotics, in general should not be prescribed to ensure there is no sedative hangover during the day.

For patients dependent on hypnotics, especially the elderly, careful evaluation of risk benefit ratios to stoppage should be undertaken before being stopped.

Abusive use of hypnotics warrants discontinuation with adjunctive addiction counselling. All stoppages should follow tapering regimens to circumvent withdrawal reactions.

 

Prescribed agents also used but not licensed as hypnotics

Sedative antidepressants in low doses are in common use but with the qualified exception of trazodone are poorly supported by data and carry significant side effect burdens.

There have been several studies reporting trazodone as being effective in treatment insomnia for patients on SSRls or SNRls. 

Antihistamines are not recommended due to daytime sedation despite widespread use.

Sedative neuroleptics are only appropriate when secondary indications apply.

 

 

Section 6. Parasomnias in Adults Guidelines 

Introduction

Parasomnias are undesirable phenomena that occur predominantly during sleep and are disorders of arousal, partial arousal and sleep state transitions. According to the Classification of Sleep Disorders  (ICD-9) they are divided into 4 main categories.

 

1. Arousal disorders - sleepwalking, night terrors and confusional arousals

2. Sleep - wake transition disorders - sleep starts and sleep talking; rhythmic

    movement disorder and leg cramps

3. Parasomnias associated with REM sleep – including nightmares, sleep paralysis

    and REM sleep behaviour disorder (RBD)

4. Other parasomnias - including bruxism and eneuresis.

 

However, parasomnias are relatively uncommon in adults. There are no international guidelines in the literature apart from those relating to polysomnography. Milder cases can probably be managed in primary care. More severe and complex cases should be referred to Sleep Service  +/- neurologist

 

Epidemiology

There are no data available estimating the prevalence of parasomnias in the Irish population and international data are incomplete. Arousal parasomnias are common in childhood but normally fade out in adolesence.

 

Prevalence in Adults

Sleep walking (> 1/month)                                              0.5 – 3%

Night terrors and confusional arousals                           Unknown

Sleep talking (frequently)                                               3% 

Nightmares                                                                      5%

Sleep paralysis                                                               11%

REM sleep behaviour disorder                                       Unknown

 

Pathophysiology

Sleep walking and night terrors are parasomnias characterized by a sudden arousal from deep or slow wave sleep (SWS) either in the first or in subsequent sleep cycles.  The arousal is associated with a dissociated reaction between cortical activity and an elaborated motor activity in sleepwalking and an autonomic discharge in night terrors. The increase in the depth of sleep, assessed by EEG, during the preceding minutes may partially explain this dissociation.  The deep sleep of patients who sleep walk and have night terrors is unusually fragmented by frequent brief arousals and this can be seen during polysomnography even in the absence of major events.

Animal experiments have revealed that in RBD, in addition to a lack of typical muscle atonia in REM sleep there is a disinhibition of motor activity in the cortex. In patients with this disorder, the EMG tone on polysomnography remains elevated and there may be excessive jerking.

 

Arousal Disorders:

Symptoms of Sleep-walking

Family history is frequent.

Involves partial arousal from deep sleep.

Usually occurs in the first 1/3 of the night. Lasts 1 – 5 minutes but may be longer.

Communication is difficult or impossible.

Behaviour can be complex and may have symbolic meaning.

Violence or aggressive behaviours are rare.

Injuries may arise but are uncommon.

Facilitating factors: sleep deprivation, CNS depressants, stress, distended bladder and sleep apnoea syndrome.

 

Symptoms of Night Terrors

Family history is common.

Usually first 1/3 of the night, and may be more than one episode/ night.

Last between 30 seconds and 3 minutes

Patient will sit up and scream and appear to be in a state of terror with tachycardia, tachypnoea, dilated pupils and impossible to reassure.

May evolve into sleep walking or running.

Can be very dangerous as patient tries to escape or inappropriately protect bed partner. Episodes tend to ‘run themselves out’ and memory is of terror and a static image.

Underlying psychopathology is common.

 

Symptoms of Confusional Arousals

Episodes of marked confusion during and after arousal but without sleepwalking or sleep terrors. The subject wakens only partially and exhibits marked confusion, disorientation and perceptual impairment. Behaviour is often inappropriate.

The confusion lasts several minutes to half an hour.

Predisposing factors include anything that deepens sleep or impairs ease of wakening – in adults recovering from sleep deprivation, fever, and CNS depressant medications.

It can also occur in a variety of medical conditions such as metabolic, toxic and other encephalopathies, sleep apnoea syndrome and idiopathic hypersomnolence.

Where there is no obvious cause, a family history is usually found.

 

Parasomnias associated with REM Sleep

Symptoms of Nightmares

Nightmares generally occur in the second half of the night within REM sleep.

They are a succession of images with threatening content.

Wakes the patient but there is less terror than in night terrors and little prolonged confusion. Last 4-15 minutes. Theme can recommence after a period of wakefulness and be repetitive.

May be precipitated by certain drugs:  beta blockers and  l-dopa and its agonists.

Withdrawal from REM –suppressant medications and alcohol may be triggers.

Severe obstructive sleep apnoea syndrome and narcolepsy are also associated with nightmares. Nightmares can be associated with past or present stress.

But in 50% of adults no underlying cause, apart from simple day-to-day stress, is found.

 

Symptoms of REM Sleep Behaviour Disorder (RBD)

Characterized by vigorous movements related to unpleasant and often combative dreams.

Vigorous and violent behaviours of RBD commonly result in injury, which can at times be severe and even life-threatening to both patient and bed partner. 

The acute form is usually associated with medication toxicity, drug abuse, drug withdrawal, or withdrawal from alcohol abuse.

Chronic form occurs primarily in males – 85%. The chronic form may be idiopathic or associated with neurodegenerative diseases that involve the brain stem structures that regulate REM sleep, such as Parkinson’s disease, dementia with Lewy bodies and multiple system atrophy. In some patients it may precede the motor and cognitive symptoms.

Mean age at presentation in 3 large studies ranged from 53 – 62 years. Sometimes there is a prodromal period where sleep talking, yelling and body jerking but no complex behaviours take place.

Pseudo RBD can occur in severe obstructive sleep apnoea syndrome and responds to treatment with nasal CPAP. A close association has also been found between RBD and narcolepsy. It may be associated with antidepressant medication.

 

Symptoms of Sleep Paralysis (isolated)

Sleep paralysis consists of episodes of inability to perform voluntary movements either at sleep onset or on wakening.

Although it is one of the classic symptoms of narcolepsy, it occurs much more frequently on its own.

Characteristically, limb, trunk and head movements are impossible but patient is able to move the eyes and make some degree of respiratory effort.

Episodes typically are brief and disappear spontaneously or are aborted by someone touching them.

They appear more frequently when patient is ‘overtired’ or in shift workers and rarely require specific treatment.