Sleep Apnea & Snoring
 
Sleep Disordered Breathing| Parts of the Airway | Spectrum of Severity
Manifestations Attributed to OSDB | Snoring | Obstructive Sleep Apnea | Cost of OSDB

Overview

Sleep Disordered Breathing (“SDB”) is characterized primarily in two ways:

(i)      as a central nervous system disorder, wherein the patient “forgets” to breath (approximately 5% of all diagnosed cases of SDB), or

(ii)     as an airway obstruction disorder wherein the soft tissues at the back of the throat collapse during sleep and block the airway (approximately 95% of all diagnosed cases of SDB).  This is referred to as Obstructive Sleep Disordered Breathing (“OSDB”).

The Company’s products are effective in treating SDB conditions that are obstructive in nature, i.e. in treating OSDB.

Obstructive Sleep Disordered Breathing

When a patient’s airway becomes obstructed, the patient awakens.  Recurrent awakenings disturb the sleep pattern, resulting in lack of rest and sleepiness during the ensuing day.  The lack of proper sleep time affects the body’s ability to regulate itself with hormonal and neural controls that may increase the likelihood of a variety of secondary illnesses.  Recurrent obstructions have a negative effect on the respiratory and cardiovascular systems, making it necessary for both the lungs and the heart to work harder to collect and distribute oxygen throughout the body during sleep.  This may lead to complications including congestive heart failure and stroke.  Recurrent obstructions have a negative effect on the tissues in the throat where the collapse occurs, causing these tissues to swell, thus increasing the likelihood of additional obstructions.

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Parts of the Airway

The term “sleep-disordered breathing” has often been used synonymously, but erroneously, with the term “obstructive sleep apnea syndrome” (“OSA Syndrome”).  In a broader sense, however, the disorders of breathing during sleep exist along a spectrum of severity from intermittent snoring, to upper airway resistance syndrome (“UARS”) to apnea and hypopnea.

OSA, or obstructive sleep apnea, refers to the temporary cessation of airflow during sleep for 10 seconds or more despite continuing ventilatory effort, whereas hypopnea means a drop in blood oxygen more than 4%.  The two conditions often overlap each other in the same patient.  On the other hand, UARS is characterized by frequent arousals in response to increased respiratory effort as a result of upper airway narrowing, without overt apnea or hypopnea.

The mildest form of sleep related breathing disorder is intermittent snoring, which is primarily a nuisance without significant health consequences.  The most severe form of disordered breathing is the “obesity-hypoventilation syndrome” which is associated with severe morbidity and very high mortality.  Between these two extremes are persistent snoring, upper airway resistance syndrome, and OSA Syndrome.[1]  These conditions are illustrated in the following table.

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Spectrum of Severity

Consequences of Non-Treatment of OSDB

*Persistent snoring is a strong indication of the presence of UARS and OSA Syndrome but may occur without either condition.

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Some of the manifestations attributed to OSDB are:

• Weight gain;

• Attention deficit and poor memory;

• Increased sick time;

• Poor job performance;

• Decreased interest in sex;

• Hypertension;

• Heart disease; and,

• Accidents (sometimes fatal) either on the job site or while driving.

OSA is directly associated with congestive heart failure and other heart diseases such as pulmonary hypertension, cardiac arrhythmia, ischemic heart disease and stroke[2].  It is estimated that OSA may be responsible for 38,000 cardiovascular deaths per year in the United States alone and that as many as 95% of OSA sufferers may be undiagnosed[3].

Snoring

With snoring, the airway collapses partially causing the soft tissues in the back of the throat to vibrate as air passes through the narrowed airway, resulting a snoring sound.  Snoring in its most benign form is a social complication and has not been considered a serious problem by the medical community to date.  Snoring can be a nuisance to bed partners and is an indicator that the snoring individual may have, or develop, a more severe form of OSDB problem as they age.  Snoring affects the majority of OSDB patients and presents a significant market opportunity for therapy.  The National Sleep Foundation (USA) states that more than one-third of adults (38%) report they snore at least a few nights/week.  Snoring is more prevalent in men (45% vs. 31%).  Nearly half of those with hypertension/high blood pressure (46%), and more than half of people with diabetes (53%) say they snore.  As the population ages, snoring increases and the symptoms of sleep disordered breathing become worse. 

Snoring can be broken into two categories:  intermittent snoring and persistent snoring.  Intermittent snoring does not affect the sufferer during each night of rest and, although it may be caused by OSDB, intermittent snoring may be triggered or exacerbated by one or more of the following factors:

• Obesity;

• Smoking;

• Alcohol consumption; or,

• Late night eating.

Persistent snoring is more likely a symptom of OSDB than intermittent snoring and causes the sufferer to endure repeated interrupted sleep patterns on a nightly basis.  This can cause the persistent snorer to experience the following related ailments:

Morning headaches;

• Early afternoon fatigue;

• Lack of concentration;

• Obesity;

• Hypertension; and,

• High blood pressure.

These factors above can affect personal relationships as well as job related performance and may be attributed to death in the case of those individuals who are suffering from sleep deprivation while operating a vehicle or performing tasks which require alertness.

Upper Airway Resistance Syndrome (“UARS”) is the occurrence of a partially collapsed airway resulting in dramatic swings in pressure within the chest of the individual who suffers from UARS.  When these frequent arousals from sleep occur, the patient is said to have UARS.  UARS can cause severe sleepiness and may eventually develop into OSA.  Approximately 80% of patients with UARS are persistent snorers and for the purposes of this business plan have been included in the category of persistent snorers.  UARS sufferers do not experience oxygen desaturation like those with OSA.

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Obstructive Sleep Apnea

A study released in 1993 estimated that 2% to 4% of the adult population[4] in North America suffer from Obstructive Sleep Apnea (“OSA”), though some studies put this figure as high as 15%[5].  According to the National Sleep Foundation 28% of men and 24% of women over the age of 65 have sleep apnea.  For the purposes of business planning the Company’s management and Clinical Advisory Board estimate that 4% of the adult population (18+ years) suffer from OSA, and that 30% of the adult population snores.  In North America alone, with a population of 211 million adults, that equates to approximately 8 million individuals.  Of that, it is estimated that only 650,000 or 8% have been diagnosed and have sought treatment, leaving more than 7 million people with OSA undiagnosed and untreated.

OSA occurs when the airway collapses completely and the patient struggles to breathe. The pressure generated by the struggle further collapses the airway, causing a drop in blood oxygen levels and the awakening of the sufferer.  People suffering from obstructive sleep apnea stop breathing many times during the night and only when the patient arouses from sleep can the obstruction be cleared.  Each episode of apnea usually ends with a loud snore, snort, or chortling sound, as breathing resumes.  Anyone can develop OSA at any age although it is more common in men.  Women are more likely to develop OSA after menopause as hormonal changes affect the tissue tone of the airway.

OSA is graded as mild, moderate or severe. Typically, sleep apnea is considered mild when the patient has from five to ten arousals from sleep (“events”) per hour, moderate when the patient has eleven to 20 events per hour, and severe when the patient has more than 20 events per hour. Some patients only exhibit apnea, or the apnea becomes more severe, during rapid eye movement (“REM”) sleep.  REM sleep occurs when the patient is dreaming and the body suspends itself into a flaccid paralysis, reducing muscle tone to its lowest level. The airway is most susceptible to collapse during REM sleep.  Arousal during REM sleep is especially harmful to the patient because it is during REM sleep that the organism gains the restorative and regenerative benefits from sleep.  Without REM sleep the subject will not feel refreshed from the sleep period and is subject to the many medical consequences of sleep deprivation.

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Cost of OSDB

It is estimated that, in the U.S. alone, $70 billion is lost in decreased productivity, lost wages, and property damage due to snoring and sleep disorders.  The U.S. National Highway Safety Traffic Authority has implemented a nationwide campaign, “Drive Alert, Arrive Alive” with the AWAKE organization to alert the public to the dangers of driving while sleepy.  It is estimated that SDB disorders are responsible for a large portion of these societal costs, as evidenced by the volume of patients who enter sleep diagnostic centers each year with symptoms of SDB conditions.  The U.S. National Highway Traffic Safety Administration estimates that sleepiness is a causative factor in about 100,000 police reported traffic crashes each year and about 4% of all fatal motor vehicle accidents.

A 1999 study by the British Columbia Workers Compensation Board rated truck driving as the second most hazardous occupation.  OSA has been named as the number one cause of truck driver fatalities in B.C.  Several states in the US, including Texas and Pennsylvania, are considering legislation that would require applicants and holders of commercial vehicle permits to undergo medical evaluation for the presence of sleep disorders.  Such legislation could significantly increase the demand for effective OSDB treatment—which the Company offers.  Such legislation would also likely have a favorable impact on reimbursement issues among insurers and managed health care organizations.

“OSA patients use approximately twice the health care resources in the ten years prior to their diagnosis.” Sleep Research Online1 (1): 71-74, Ronald, Delaive, Roos, Manfred and Kryger.

A detailed examination of this study reveals that while the overall use of the health care system for OSA patients is twice the average of the control group, in the four years prior to diagnosis the utilization of physician services by the OSA group grew by a factor of 10. This research confirms that the condition of OSA deteriorates in the absence of treatment.

A significant percentage of these people remain undiagnosed and untreated.  Consequently they are exposed to unnecessary daytime sleepiness and the potential for lost productivity and increased risk of accident, not to mention the associated medical risks, including increased risk of congestive heart failure and stroke.  OSDB conditions can occur all night, but generally are more prevalent later in the night as the individual reaches a deep sleep.  This is the time when the body is most relaxed and the person tends to dream. A correlation has been suggested between OSDB and the increased observation of cardiovascular incidents.  Systemic hypertension has been reported in up to 50% of patients with OSA.

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