Sleep apnea is one of the most common sleep disturbance problems in America and throughout the world. It ruins the sleep of an estimated 25 million Americans on a regular basis. The reach of this malady is far greater than the numbers would suggest.
Sleep problems are some of the most under-diagnosed conditions in medicine. Not only is it difficult for the subject to recognize that their symptoms are sleep related, but the diagnosis requires overnight testing in a sleep laboratory at a cost of thousands of dollars. Moreover, because of the demand for this testing, it can often take months just to get an appointment in a sleep clinic and even then, the symptoms can be episodic and not fully expressed during any one brief stay.
The Centers for Disease Control have estimated that 1 in 4 adults have periodic apnea episodes disturbing their sleep.
A sleep apnea diagnosis is further complicated by aggravating conditions. Clearly, sagging soft tissues in the airway contribute to the problem. When the reduction of muscle tonus occurs during the transition from Stage I to Stage II sleep, sagging tissues in the airway will sag even more.
There are other mitigating conditions as well. A large number of people have mild allergies to wheat and dairy products. For people with these allergies, consuming these products (especially before bedtime) causes a slight swelling of the tongue and other tissues of the mouth, throat and nose.
This contributes to airway constriction and aggravates the problem. As well, some people like to drink alcohol before retiring for the evening. While alcohol is initially an intoxicant and energizes the consumer, the alcohol after-effects are essentially those of a central nervous-system depressant. All of these common issues can mitigate the sleep apnea of a person directly or indirectly.
When a patient reports to a sleep clinic for diagnosis and testing, the food that they’ve eaten, beverages that they’ve consumed and even the sleep position that they utilize during the test can have a dramatic impact on the test score that they receive for that particular night of sleep.
In fact, the results can be so varied that a person can receive a rating of mild sleep apnea for one visit and the same person can be rated with severe sleep apnea one month later on a subsequent visit. With this level of variability in the condition and the inconsistency of the diagnosis, it is no wonder that many people go undiagnosed.
Given the inconsistency and variability in sleep apnea testing, it should also be clear that conducting a clinical study to show the effectiveness of a product to treat this condition would be extremely difficult and potentially cost millions of dollars.
The presence of sleep apnea prevents the sleeper from entering REM and Delta sleep by regularly arousing the sleeper as he enters Stage II sleep. This usually occurs at such a relatively low level that the sleeper may not fully regain consciousness and is thereby unaware of the occurrence. The effect of this REM and Delta deprivation can result in the patient becoming anxious, frustrated, edgy, and tired during the day.
There are very serious health consequences of prolonged sleep deprivation. Additionally, due to the nature of the condition, it causes blood oxygen levels to be lower than normal for prolonged periods. This can be damaging to the brain and heart in particular.
Presently, there are several ways in which the problem is addressed. Initially, the patient is told to lose weight, drink less alcohol and quit smoking. Unfortunately this approach is difficult as human nature and success in these areas is limited if not altogether impossible.
Moreover, almost half the U.S. population is overweight, there are still many smokers (including the new “vape” smoking), and and people who drink plenty off alcohol. To further complicate this situation, many people smoke without developing sleep apnea and many people drink alcohol and/or drink without suffering from it.
This causes the patient to look around at the community and say, “why do I have to stop these behaviors, since they are not obvious causes?” The patient is correct in asking that question.
Beyond stopping what are generally regarded as bad habits, surgery is often offered to reduce obstruction in the inhalation pathway. This has provided some success, but the procedure is painful and often provides limited or no prolonged relief. It actually addresses an aggravating physical condition, not the actual cause of sleep apnea, and thus tends to work only in situations where the aggravating condition is quite profound.
The last option is for the patient to purchase and wear a CPAP device. This is a forced-air mask, worn during sleep, that ensures proper inhalation. Unfortunately, most patients are not willing to go to this expense or to endure this level of discomfort and annoyance from the obstructive machinery and the resultant nasal irritation.
Further, the noise can be disturbing to other sleepers in the room and the equipment can develop and harbor germs. Additionally, the processed air often dries out the patient’s airway, causing discomfort. The equipment is cumbersome and difficult to transport, requires constant purchase of disposables and makes it very difficult and uncomfortable to sleep.
Research has shown that 60% of the patients who try CPAP are unable to tolerate the equipment over the long-term. The non-compliance rate is so high that insurance companies that provide the equipment to their subscribers are using software embedded within the CPAP that monitors usage. If the subscriber doesn’t continue to use the equipment, the insurance company can recall it and not provide future payments.