Q: What is Obstructive Sleep Apnea?

A:: Obstructive Sleep Apnea (OSA) is the most common form of sleep-disordered breathing, characterized by repeated narrowing or collapse of the upper airway during sleep that restricts or prevents airflow. For people experiencing OSA, the number of involuntary breathing pauses or "apneic events" in a given night may be as high as 20 to 60 or more per hour, each lasting 10 seconds or longer. While these breathing pauses usually are accompanied by snoring, not everyone who snores has this condition.

Q: Who gets Obstructive Sleep Apnea?

A: OSA is a serious health issue believed to affect more than 18 million Americans - 2% of all women and 4% of all men. Published reports claim that 24 percent of middle-aged men and 9 percent of middle-aged women have sleep apnea, along with excessive daytime sleepiness. Only 5% of people with OSA have currently been diagnosed. People most likely to have or develop sleep apnea include those who snore loudly, are overweight, have high blood pressure, or have some physical abnormality in the nose, throat, or other parts of the upper airway.

Q: What causes Obstructive Sleep Apnea?

A:: Collapse and blockage of the upper airway causes the interruptions in breathing during sleep. Apnea usually occurs when the throat muscles and tongue relax during sleep and partially block the opening of the airway. Muscles at the base of the tongue, the soft palate and the uvula (the small fleshy tissue hanging from the back of the throat) relax and sag, block the airway and make breathing labored and noisy, or temporarily stop it altogether.

Q: What are the implications of Obstructive Sleep Apnea?

A:: The morbidity and mortality rates associated with sleep apnea are significant. Recent research shows OSA is a potentially life-threatening disorder that correlates to high blood pressure and is strongly associated with congestive heart failure, irregular heartbeat, and greater risk of heart attack or stroke. Sleep-disordered breathing in patients with coronary artery disease is associated with a 60-70% increase in the risk of death and cardiovascular morbidity in long-term follow-up . A study reported in the New England Journal of Medicine found that people who experience apneic events during sleep are up to three times more likely to develop high blood pressure, with increased rates of systemic hypertension, stroke, angina, myocardial infarction, pulmonary hypertension and ventricular failure. OSA has also been linked to diabetes, depression, epilepsy, headaches, daytime sleepiness and an overall decreased quality of life . Sleep apnea, and subsequent disrupted sleep patterns, has also been clearly identified as a major cause of vehicular and industrial accidents, and impaired cognitive performance. Individuals with sleep apnea are six times more likely to be involved in a traffic accident than individuals without sleep apnea .

Q: What are the signs of Obstructive Sleep Apnea?

A:: The main symptoms of sleep apnea are chronic, loud snoring, gasping or choking episodes during sleep, and excessive daytime sleepiness (EDS). EDS can result in cognitive difficulties, irritability, mood changes, anxiety or depression. Another warning sign is early onset of high blood pressure (hypertension). Possible predictors of OSA are obesity, a thick neck, family history, or anatomic abnormalities in the upper airway or facial structure. Age, male gender, smoking and use of alcohol or sedatives also have been correlated to an increased risk of OSA.

Q: When should Obstructive Sleep Apnea be suspected?

A:: Bed partners or family members are often the first to suspect that something is wrong, usually based on heavy snoring and apparent struggle to breathe. Coworkers or friends of a sleep apnea sufferer may notice that the individual falls asleep during the day at inappropriate times, such as while driving a car, working or talking.

Q: How is Obstructive Sleep Apnea diagnosed?

A:: In addition to the primary care physician, ear, nose and throat (ENT) doctors, pulmonologists, neurologists, or other physicians with specialty training in sleep disorders may be involved in making a definitive diagnosis and initiating treatment. Polysomnography (PSG) is the standard procedure for diagnosing OSA. Performed in a sleep laboratory and attended by a sleep technician, PSG records a variety of body functions during sleep, including heart rate, respiratory effort, airflow and blood oxygen levels, as well as the electrical activity of the brain, eye movement and muscle activity. The procedure is used to diagnose sleep apnea and determine its severity. NovaSom® QSG® is provided as a diagnostic service for at-home testing and evaluation of OSA. The physician-prescribed service uses the only device cleared by the U.S. Food & Drug Administration specifically designed for unattended and unassisted use in the patient's home and clinically proven to be equivalent to in-laboratory PSG. The system can collect up to three nights of sleep data, including respiratory events, snoring intensity, blood oxygen saturation level, pulse rate and respiratory effort. A comprehensive report is provided to the referring physician for diagnosis.

Q: How does Sleep Solutions' diagnostic service work?

A:: When ordered by a physician, Sleep Solutions delivers the NovaSom® QSG® directly to the patient's home. An instructional packet and video guides the patient through the setup. The patient simply applies three small, comfortable sensors and then pushes the "Start" button. Voice prompts guide the patient through the process and alert them if any of the sensors are displaced during the night. After up to three nights of use the patient places the system back in the original shipping box and returns it to Sleep Solutions using the enclosed prepaid airway-bill. The data is extracted and analyzed, and a comprehensive summary of the data is prepared and delivered to the referring physician via mail, fax, secure posting on Sleep Solutions' Web site or automatic electronic transfer via the Internet.

Q: How does the NovaSom® QSG® detect sleep apnea?

A:: The multi-channel system monitors respiration airflow, oxygen saturation, heart rate, respiration effort and snoring sound intensity. The system utilizes proprietary audio digital-signal processing (DSP) technology to sense, analyze and process respiratory sounds and convert the sounds to airflow volume. Through analysis of this data, the frequency of apneas (cessation of breath) and hypopneas, (prolonged decreases in airflow) is determined to produce an Apnea and Hypopnea Index (AHI), indicating the severity of OSA.

The NovaSom® QSG® consists of a bedside unit containing the signal processing and memory circuitry, a portable processing unit and the three sensors. Once the system is returned to Sleep Solutions, proprietary software retrieves and processes the data to generate a comprehensive Sleep Study report for the physician.

Q: How does Sleep Solutions' diagnostic service help doctors?

A:: Sleep Solutions' comprehensive diagnostic service simplifies the physician's job of performing sleep testing and tracking the patient's progress. Once the physician orders a test by phone, fax or through the company's secure Web site, Sleep Solutions handles everything, from delivering the device to the patient to analyzing the data and generating a concise Sleep Study report. Requiring no equipment purchase, maintenance or staff training, Sleep Solutions' service enables any practice to quickly and cost-effectively manage any volume of patient testing, without straining precious resources.

Q: How does Sleep Solutions' diagnostic service help patients?

A:: Sleep Solutions' service makes it easier and more convenient for patients to undergo testing for sleep apnea by offering an alternative to a sleep study in a hospital laboratory or sleep center environment. Essential parameters (apneas, hypopneas, oxygen saturation, pulse rate, respiratory effort and snoring intensity) can be analyzed in the comfort of the patient's home for up to three nights, providing a clinically validated analysis of the patient's breathing during sleep in a comfortable environment. Direct residential delivery provides access to quality OSA testing to all patients, even in remote areas. Patient satisfaction surveys show that 93% of patients had no difficulty applying the NovaSom® QSG® sensors at home, without assistance.

Q: Has the NovaSom® QSG® been clinically tested?

A:: The NovaSom® QSG®, based on proprietary sound analysis technology, is the first physician-prescribed at-home diagnostic product that has undergone rigorous clinical validation. The system is the only device cleared by the U.S. Food & Drug Administration specifically designed for unattended and unassisted use in the patient's home and clinically proven to be equivalent to in-laboratory PSG for diagnosis of OSA. Published data from clinical trials demonstrate an overall event-to-event correlation of 96% to the conventional PSG diagnostic systems.

Q: Why is the NovaSom® QSG® designed to collect three nights of data?

A:: A multi-night study provides the flexibility to measure the different effects of factors such as medicine usage or alcohol consumption from one night to the next. Multiple nights of data also minimize the "first night effect" that has been shown to impact the reliability of lab-based sleep studies. Recent research suggests that single-night studies may not be adequate to safely reject a diagnosis of sleep apnea since the testing conditions and environment may disrupt the patient's normal sleep pattern .

Q: How is Obstructive Sleep Apnea treated?

A:: OSA can be treated a number of ways. The most effective and widely used first-line therapy is Continuous Positive Airway Pressure (CPAP), in which the patient wears a mask over the nose that delivers a constant stream of air through the nasal passages at a precise pressure to prevent airway collapse. Other options include behavioral modifications and surgical options to expand the air passage.

Q: How large is the market for diagnosing and treating Obstructive Sleep Apnea?

A:: Sleep disorders represent a growing area of opportunity with many unmet needs in both diagnosis and treatment, according to a survey published by Decision Resources Inc., a subsidiary of Arthur D. Little Inc. An estimated 36 million Americans who snore chronically are candidates for a sleep apnea test. Healthcare costs for sleep apnea have been estimated at more than $15 billion. Awareness among physicians about the potentially serious outcomes of OSA has increased over the last several years, however sleep apnea is still widely underdiagnosed.

Q: What is the cost impact of Obstructive Sleep Apnea on the healthcare system?

A:: Prior to diagnosis and treatment, people suffering from OSA use twice the healthcare resources and spend nearly three times as many days in the hospital . Patients with untreated OSA have clinically significant low health status comparable to arthritis, angina, back problems and diabetes.