Sleep Disordered Breathing - Standard Treatment Guidelines

Ministry of Health and Family Welfare, Government of India has issued the Standard Treatment Guidelines for Sleep Disordered Breathing. Following are the major recommendations :

Introduction:

• Sleep disordered breathing (SDB) constitutes a spectrum of disorders of various severity with intermittent snoring as the mildest form at one end and obesity hypoventilation syndrome (OHS) , the most severe form at the other end of the spectrum. Heavy snoring and upper airway resistance syndrome (UARS); mild, moderate and severe sleep apnea lie in between these two extremes. Because of the uncertainty about what constitutes sleep apnea, the term SDB is used to describe events that do not satisfy criteria as apneas and hypopneas according to the conventional criteria, but which carry some of the same consequences, like, snore-arousals or respiratory effort-related arousal (RERA) or flow limitations.


• Apnea: cessation of airflow >10 seconds with or without respiratory effort


• Hypopnea: recognizable, transient reduction, but not a complete cessation of breathing >10 seconds. A>50% decrease in the amplitude of a validated measure of breathing must be evident or a <50% amplitude reduction that is associated with either an oxygen desaturation of >3% or an arousal on electroencephalography (EEG)


• Respiratory effort - related arousal (RERA): is an event characterized by increasing respiratory effort for > 10 seconds leading to an arousal from sleep, but which does not full fill the criteria for hypopnea or apnea.


• Apnea - Hypopnea Index (AHI): defined as the number of obstructive apneas and hypopneas per hour


• Respiratory Distress Index (RDI): is defined as the number of obstructive apneas, hypopneas, RERAs and flow limitations per hour averaged over the course of at least 2 hours of sleep as determined by nocturnal polysomnography (PSG).


• The term apnea-hypopnea index (AHI) is most commonly used conventional criteria to diagnose and quantitate the severity of sleep apnea, however recently as per the guidelines of American Academy of Sleep Medicine (AASM) the term respiratory disturbance index (RDI) is increasingly used to diagnose and describe SDB which includes besides apneas, hypopneas other events such as RERAs, and flow limitations.

Case definition:

Diagnostic Criteria for OSAS (1)

A) Excessive Daytime Sleepiness (EDS) not better explained by other causes

B) Two or more of the following not better explained by other causes

• Choking or gasping during sleep


• Recurrent awakenings from sleep


• Un-refreshing sleep


• Daytime fatigue


• Impaired concentration

C) PSG showing AHI > 5 in adults and >1 in children

OSAS must fulfill A or B, plus criterion C

• The newly revised International Classification of Sleep Disorders defines OSAS as when a patient has an RDI of five or more than five per hour of sleep with the appropriate clinical presentation such as excessive daytime sleepiness, un-refreshing sleep, fatigue, insomnia, mood disorders or other neuro-cognitive disturbances. The severity of SDB is assessed by the number of abnormal breathing events per hour of sleep, degree of sleepiness and the degree of oxygen desaturation during sleep.

Severity Grading of OSAS (criteria for children) (2)

Incidence of The Conditions In Our Country

The prevalence of SDB varies from region to region. It has been found to be present in 4% of men and 2% of women. In India various studies have shown the prevalence of SDB of 2.6% to 4.9% in adult males and 1% to 3.6% in adult females. About 4.8% children and 10.3% of elderly population in India have SDB. No gender difference in the prevalence of SDB has been observed in children and elderly subjects.

The factors associated with the pathogenesis of SDB include anatomically small airway, obesity, and loss of upper airway motor tone during sleep and dysfunction of central respiratory control. The various risk factors are body habitus (especially percentage of predicted neck circumference), obesity, genetics, craniofacial morphology, chronic rhino-sinusitis with nasal obstruction, smoking and alcohol consumption.

Differential Diagnosis

• Narcolepsy


• insomnia


• Sleep hygiene disorder


• Depression


• Drug effect


• OHS


• Habitual snorers


• Restless leg syndrome

Clinical Features

The night-time symptoms of SDB include:

• Loud, disruptive snoring


• Nocturnal pauses in breathing


• Gasping or choking for air during sleep


• Restless sleep


• Nocturia

The daytime symptoms of SDB include:

• Feeling of excessive daytime sleepiness


• Grogginess and morning headache


• Memory or leaning problems


• Not being able to concentrate at work


• Depression and irritability


• Sexual dysfunction


• Dry throat upon awaking


• Frequent nocturnal enuresis

The symptoms seen in women include:

• Report typical symptoms less frequently


• Under-report snoring and underestimate symptom severity as compared to men


• Non-specific somatic complaints such as insomnia, fatigue, myalgias, and morning headache


• Amenorrhea and dysmenorrhea


• Depression, anxiety and social isolation


• Women tend to be more obese than men for the same degree of severity

PRESENTATION IN CHILDREN

Nocturnal symptoms in children include

• Snoring


• Restless sleep


• Mouth breathing


• Struggle to breathe/ gasp for air


• Bed wetting

Daytime symptoms in children include

• Feels depressed, sad or irritable


• Sleepy during the day

1. Feels fatigued or tired during daytime


2. Excess activity, short attention span


3. Learning difficulties


4. Falling school performance


5. Difficulty to concentrate and memory lapses


6. Enlarged tonsils and adenoids

Consequences of SDB are as follows:

Physiological

• Cardiovascular – Metabolic syndrome, hypertension, cerebrovascular accidents, coronary artery disease


• Alterations in inflammatory biomarkers

Behavioral

• Tiredness in the morning


• EDS in permissive situation


• Increased risk of motor vehicle accidents


• Losses of concentration and productivity


• Epworth Sleepiness Score & psychomotor vigilance test are abnormal


• Behavioral effects can be variable amongst patients


• Behavioral measurement alone are insufficient

Social effects

• Principally related to snoring


• Disrupts social harmony by disturbance of bed-partner and others in a home


• Falling asleep at social gatherings


• Subjective measures are commonly used


• Bed-partner scoring

Prevention And Counseling

Risk factor reduction:

• Weight reduction


• Avoid alcohol and cigarette smoking


• Treatment of nasal congestion


• Surgical treatment of tonsillar and adenoid hypertrophy


• Good sleep hygiene


• Awareness about sleep disorders


• Diagnosis and timely treatment of hypothyroidism

Optimal Diagnostic Criteria, Investigations, Treatment & Referral Criteria

*Situation 1: At Secondary Hospital/ Non-Metro situation: Optimal Standards of Treatment in Situations where technology and resources are limited

Clinical Diagnosis:

The diagnosis of SDB depends on properly taken history from the patient and the bed-partner regarding the typical daytime and night-time symptoms. Comorbid conditions like hypertension, diabetes and other metabolic and hormonal problems. Good physical examination taking into account body mass index (BMI), neck length, percentage of predicted neck circumference (PPNC), cranio-facial anomalies like micrognathia and retrognathia, and evaluation of the upper airway using clinical examination scores, eg. Friedman score, X-ray cephalometry, CT scan, MRI, and videoendoscopy. For the localization of the site of the obstruction multi-channel pressure measurement has also been used with some success.

The gold standard test for the diagnosis and severity assessment of SDB is clinical polysomnography (PSG); however, there are many practical considerations and clinical caveats in PSG interpretation in sleep related sleep disorders.

History should include any history of sleep problem, sleep diary, medication history, medical problems, work history-shift work, alcohol or drug use, periodic limb movement disorders, dream history and teeth grinding.

Physical examination should include measurement of body mass index (BMI; kg/m2 ), neck circumference and waist/hip ratio, examination of nose, oral cavity, oropharynx, bony structure of head and neck. Sleep endoscopy is rarely needed to confirm airway collapse.

Investigations:

• Thyroid function tests


• Blood sugar (fasting and post-prandial)


• Serum insulin (fasting and post-prandial)


• HbA1c


• Lipid profile


• ECG and echocardiography


• Pulmonary function testing (if overlap with chronic obstructive airway disease is suspected)


• Arterial blood gases [if overlap with chronic obstructive airway disease or obesity-hypoventilation syndrome (OHS) is suspected]


• Polysomnography

1. Full-night diagnostic study


2. Split-night with CPAP titration


3. Home study


4. Multiple Sleep Latency Testing (MSLT) if narcolepsy is suspected

Requirement for standard diagnostic nocturnal polysomnography (PSG) includes recording and analysis of the following parameters: EEG, (EOG), (EMG), oro-nasal airflow, chest wall effort, body position, snore microphone, ECG, and oxyhemoglobin saturation. The duration of a diagnostic NPSG is at least 6 h with the exception of the diagnostic portion of a split-night study, which is at least 2 h in duration.

The various levels (types) of PSG are as follows

Type 1- gold standard, in-lab, attended PSG

Type 2- Comprehensive portable monitoring, unattended

Type 3- cardio-pulmonary sleep study or modified portable sleep apnea testing

Type 2 and Type 3 are acceptable in attended setting for patients without comorbidity when scored by a trained physician

Type 3 underestimates the severity of SDB

Type 4- continuous single or dual bio-parameter recording -underestimates severity

Indications of polysomnography are as follows:

• For the diagnosis of SRBD and CPAP titration


• Symptomatic patients with negative portable studies.


• Full night PSG is required for CPAP titration of documented case of SDB; RDI > 15/hour or RDI > 5 with EDS


• Evaluation of narcolepsy, and parasomnias


• Before and after the application of dental appliances to assess the therapeutic benefits


• Before and after upper airway surgery for snoring and SDB


• After significant (10%) weight gain or weight loss


• Patients with specific medical condition

1. Coronary artery disease


2. Congestive heart failure


3. History of stroke


4. Treatment of transient ischemic attack (TIA)


5. Significant tachy- or brady- arrhythmias

Indications for split-night study include:

• AHI > 40/hour of at least 2 hours of sleep.


• AHI between 20 and 40 in the presence of repetitive lengthy obstructions and major de-saturations.


• CPAP titration must be carried out for more than 3 hours.


• PSG documentation of abrogation of all events with CPAP.

Treatment:

Treatment decision is based on evaluation of the patient’s history, anatomy, disease severity, symptoms and presence of co-morbidities. The severity of disease depends on

• Severity of symptoms


• Apnea hypopnea index (AHI)


• Degree of oxygen desaturation

1. Minimum O2 desaturation


2. Sleep time spent below 90% oxygen saturation

• Effect on sleep architecture

1. Presence or absence of REM and Delta sleep

• Respiratory distress index (RDI)

1. Includes arousals with apneas and hypopneas

All modes of treatments should be discussed and these include behavioral treatments, use of oral appliances, positive airway pressure (PAP) therapy and surgical therapy while providing real information about success with each mode of treatment.

The behavioral modifications

• Can reduce or eliminate OSA without the need for medication, device use or surgery.

1. Sleep hygiene counseling


2. Sleep position therapy


3. Lifestyle modification and weight reduction


4. Avoidance of sedatives and alcohol


5. Smoking cessation


6. Avoidance of large meals before bedtime

Continuous positive airway pressure (CPAP) is the gold standard for treatment of OSAS. It acts as a pneumatic splint to keep airway patent. The benefits of CPAP include the following.

• Minimally invasive and reversible


• Reduction and/or reversal of OSA-related signs and symptoms Like snoring, excessive daytime sleepiness, un-refreshing or fragmented sleep, cognitive impairment


• Decrease risk of accidents


• Increased productivity


• Decrease long-term complications of OSA like hypertension, heart disease, stroke, and death

Common adverse events of CPAP are as follows:

Minor (30-50% of Patients)

1. Inconvenience


2. Skin ulceration due to mask


3. Poor mask fit


4. Claustrophobia


5. Various nasal problems (15-45%)

Major

1. Massive epistaxis


2. Pneumocephalus – following recent surgery or trauma causing CSF leak

Guidelines for titration

• Patient should be evaluated for awake respiratory failure, congestive cardiac failure, and marked nocturnal hypoxemia.


• CPAP titration should ideally be done in the hospital under supervision of a trained technician.


• Patient should receive adequate PAP education, hands on demonstration, careful mask fitting and acclimatization


• CPAP should be increased till all the obstructive events: apneas, hypopneas, RERAs, snoring and desaturation dissapear.


• Recommended minimum pressure is 4 cm and maximum of 15 cm (<12 yrs) and 20 cm H2O (> 12 yrs)


• CPAP pressure of 1 cm H2O should be increased with an interval no shorter than 5 min.


• CPAP pressure should be increased by 1 cm H2O

1. 1 apnea (<12 yrs) or 2 apneas (> 12 yrs)


2. 1 hypopnea (<12 yrs) 3 hypopneas (> 12 yrs)


3. 3 RERAs (<12 yrs) 5 RERAs (> 12 yrs)

• Use of BiPAP is recommended if CPAP titration pressure is > 15 cm H2O


• Titration algorithm is same for split-night study

Titration in patients with cardio respiratory failure

• Requires close supervision by trained technician or physician while commencing CPAP.


• Many patients might require endotracheal intubation or urgent tracheostomy.


• The patient may become confused or delirious due to deranged blood gases.


• In trained hands, judicious use of CPAP or BiPAP can control breathing disturbances.


• Auto CPAP should not be used

CPAP adherence

• No clear field standard exist

1. Too few studies to define amount of adherence needed to treat common sequelae

• Average patient uses CPAP about 5 hours per night


• Most clinicians generally recommend CPAP use for more than 4-5 hours per night on ≥ 70% of all nights

Predictors of CPAP adherence

• Early use patterns predict long-term adherence

1. Patients appear to establish their patterns of use by the first month (as early as 4 days)


2. Adherence at 1 month appears to predict adherence at 3 months


3. Since adherence is established by 3 months, alternative forms of therapy should be considered for non-adherent patients

Factors affecting CPAP adherence

Patient related factors:

• Lesser severity of symptoms


• Little or no perceived benefit from therapy


• Failure to understand importance of or directions for CPAP use


• Use of prescription/non-prescription drugs or alcohol


• Lack of social support


• Other medical illnesses or fatigue


• Physical limitations (i.e. vision, hearing, hand coordination)

Therapy related factors:

• Complexity of therapy/device use


• Increased rate of adverse reactions that go unaddressed


• Lack of efficacy


• Expense of therapy


• Chronic nature of illness


• Compliance decreases over time

Clinician related factors

• Poor relationship with patient


• Lack of clinician follow-up


• Expression of doubt concerning therapeutic potential or creating falsely elevated expectations


• Poor communication skills


• Failure to identify concomitant use of alcohol and sedatives by the patient

Measures to improve CPAP adherence:

Technological interventions:

Auto-titrating CPAP

• Pressure delivery is auto-adjusted during changing airway conditions overnight

Bi-level positive pressure (BiPAP)

• Set inhalation pressure with a lower set exhalation pressure

Flexible pressure delivery (C-Flex, EPR)

• Slight reduction in pressure during early exhalation

Heated humidification

• Decreases nasal/oral dryness for comfort


• Improves nasal resistance

Pressure ramp feature

• CPAP starts at lower pressure (2-4 cmH2O) and gradually ramps up to prescribed pressure over set time period (5-45 min)

Behavioral interventions:

• Patient education


• Systematic desensitization and sensory awareness (for claustrophobia)

1. Wearing device for progressively longer periods

• Cognitive behavioral therapy/Motivational Enhancement Therapy

Reducing side effects:

Treatment with oro-dental appliances: useful for mild to moderate cases of OSAS who are not tolerant/ willing to use CPAP treatment

• Improve upper airway baseline dimensions

1. Pulling tongue forward – tongue retaining device


2. Moving mandible forward – nocturnal airway patient device (NAPA)

• Effectiveness of oral appliances

1. Significantly reduce or completely eliminate snoring


2. Significantly reduce AHI


3. Subjective improvement in daytime function but objective evidence of improvement in sleepiness lacking


4. Adverse events include excessive salivation, temporo-mandibular joint arthritis, and overall lower compliance (50%)

Patient selection for oro-dental appliances:

• Factors associated with better response

1. Younger age


2. Lower BMI


3. Lower AHI


4. Good protrusive range


5. Presence of adequate healthy denture

• However, some studies have demonstrated success even in patients with more severe OSA

Surgical treatment for OSAS

• Patient selection for surgery depends on

1. OSA severity


2. Individual patient anatomy


3. Patients option for surgery


4. Presence of co-morbidities

• Procedures used for localization of the site of obstruction

1. X-ray cephalometry, CT and MR imaging, video endoscopy under sedation and multi channel pressure measurements.

• Points of discussion while considering surgical option

1. Patient’s expectations and preferences


2. Patient’s expectation regarding cure of their snoring, apnea and symptoms of tiredness.


3. Presence of co-morbidities


4. Type of surgery


5. Pain and complication rates


6. Expected consequences


7. Morbidities


8. Cost


9. Need for evaluation following surgical procedure and possible need for subsequent surgeries

• Procedure on the upper airway, which may improve PAP use and compliance.

1. Adeno-tonsillectomy


2. Nasal surgery for hypertrophied turbinate, deviated nasal septum or nasal polyps.

• Surgery that improves OSA without surgically altering the upper airway

1. Tracheostomy


2. Bariatric surgery

• Surgery that directly alters the upper airway

Tracheostomy

1. Done on a temporary basis in the pre/peri-operative period


2. Not done routinely because of its associated hygiene and social burden


3. Typically reserved for morbidly obese patients who can’t tolerate PAP


4. Morbidly obese patients with OHS who require upper airway bypass and nocturnal ventilation


5. Patients who are unable to tolerate PAP with significant co-morbidity

Bariatric surgery

• Bariatric surgery has a potential to reduce body weight significantly as a significant number of OSA patients are obese.

Indications

• BMI > 40


• BMI > 35 with significant co-morbidities


• Has the advantage of treating other co-morbidities associated with obesity

Surgery that alters the upper airway

• Uvulopalatopharyngoplasty (UPPP)


• Tongue advancement


• Hyoid suspension


• Maxilo-mandibular advancement (MMA)

Algorithm For Treatment of OSA & Treatment Goals

Mild (AHI >5-15)

No symptoms

Behavioral modification

Symptoms

Behavioral modification

• Consider oral appliance


• Consider PAP


• Consider surgical intervention

Moderate (AHI >15-30)

No symptoms

Behavioral modification

• Consider PAP


• Consider oral appliance


• Consider surgical intervention

Symptoms

Behavioral modification

PAP

Surgical intervention for PAP failures

Consider oral appliance

Severe (AHI>30)

Symptoms or no symptoms

Behavioral modification (rarely sufficient alone)

PAP

Surgical intervention for PAP failures

• Consider tracheostomy if other treatments fail and significant symptoms or co-morbidities exist


• Co-morbidities should also be taken into account when discussing the strength of recommendations


• Patients with BMI >35 and co-morbidities or BMI>40 should be considered for bariatric surgery


• Interventions should typically be applied in the order listed. Proceed down the list until success is reached.

Follow up

Follow-up after medical and surgical intervention is critical to ensure that the patient has benefited from the chosen treatment and to provide an opportunity to implement further recommendations in case partial treatment response.

Referral criteria:

Patient should be referred when following are present:

• Severe OSAS/OHS having cardio-respiratory failure


• Co-morbidities


• Overlap syndrome (COPD or ILD with OSAS)


• Poor compliance to CPAP treatment


• Severe, intractable adverse events


• Refusal for CPAP therapy


• Consideration for oro-dental appliances and surgery


• Requiring advanced investigations like nasal endoscopy, CT or MRI etc


• Patients with complex sleep apnea

*Situation 2: At Super Specialty Facility in Metro location where higher-end technology is available

Clinical Diagnosis:

The diagnosis of SDB depends on properly taken history from the patient and the bed-partner regarding the typical daytime and night-time symptoms. Comorbid conditions like hypertension, diabetes and other metabolic and hormonal problems. Good physical examination taking into account body mass index (BMI), neck length, percentage of predicted neck circumference (PPNC), cranio-facial anomalies like micrognathia and retrognathia, and evaluation of the upper airway using clinical examination scores, eg. Friedman score, X-ray cephalometry, CT scan, MRI, and videoendoscopy. For the localization of the site of the obstruction multi-channel pressure measurement has also been used with some success.

The gold standard test for the diagnosis and severity assessment of SDB is clinical polysomnography (PSG); however, there are many practical considerations and clinical caveats in PSG interpretation in sleep related sleep disorders.

History should include any history of sleep problem, sleep diary, medication history, medical problems, work history-shift work, alcohol or drug use, periodic limb movement disorders, dream history and teeth grinding.

Physical examination should include measurement of body mass index (BMI; kg/m2 ), neck circumference and waist/hip ratio, examination of nose, oral cavity, oropharynx, bony structure of head and neck. Sleep endoscopy is rarely needed to confirm airway collapse.

Investigations:

• Thyroid function tests


• Blood sugar (fasting and post-prandial)


• Serum insulin (fasting and post-prandial)


• HbA1c


• Lipid profile


• ECG and echocardiography


• Pulmonary function testing (if overlap with chronic obstructive airway disease is suspected)


• Arterial blood gases [if overlap with chronic obstructive airway disease or obesity-hypoventilation syndrome (OHS) is suspected]


• Polysomnography

1. Full-night diagnostic study


2. Split-night with CPAP titration


3. Home study


4. Multiple Sleep Latency Testing (MSLT) if narcolepsy is suspected

Requirement for standard diagnostic nocturnal polysomnography (PSG) includes recording and analysis of the following parameters: EEG, (EOG), (EMG), oro-nasal airflow, chest wall effort, body position, snore microphone, ECG, and oxyhemoglobin saturation. The duration of a diagnostic NPSG is at least 6 h with the exception of the diagnostic portion of a split-night study, which is at least 2 h in duration.

The various levels (types) of PSG are as follows

Type 1- gold standard, in-lab, attended PSG

Type 2- Comprehensive portable monitoring, unattended

Type 3- cardio-pulmonary sleep study or modified portable sleep apnea testing

Type 2 and Type 3 are acceptable in attended setting for patients without comorbidity when scored by a trained physician

Type 3 underestimates the severity of SDB

Type 4- continuous single or dual bio-parameter recording -underestimates severity

Indications of polysomnography are as follows:

• For the diagnosis of SRBD and CPAP titration


• Symptomatic patients with negative portable studies.


• Full night PSG is required for CPAP titration of documented case of SDB; RDI > 15/hour or RDI > 5 with EDS


• Evaluation of narcolepsy, and parasomnias


• Before and after the application of dental appliances to assess the therapeutic benefits


• Before and after upper airway surgery for snoring and SDB


• After significant (10%) weight gain or weight loss


• Patients with specific medical condition

1. Coronary artery disease


2. Congestive heart failure


3. History of stroke


4. Treatment of transient ischemic attack (TIA)


5. Significant tachy- or brady- arrhythmias

Indications for split-night study include:

• AHI > 40/hour of at least 2 hours of sleep.


• AHI between 20 and 40 in the presence of repetitive lengthy obstructions and major de-saturations.


• CPAP titration must be carried out for more than 3 hours.


• PSG documentation of abrogation of all events with CPAP.


• Level I polysomnography


• Patients requiring advanced investigations like nasal endoscopy, CT or MRI etc

Treatment:

Titration and treatment of patients with severe cardio-respiratory failure Treatment and counseling of patients with poor CPAP adherence Oro-dental appliances and surgical treatment

Standard Operating procedure

As mentioned above

WHO DOES WHAT? and TIMELINES

Doctor

Diagnosis and Management including counseling

Nurse

Implementation of orders, monitoring of patients and counseling

Technician

Investigations

Resources Required For One Patient

Guidelines by The Ministry of Health and Family Welfare :

Dr S.K. SHARMA AIIMS