Method of sleep time measurement

Horology: time measuring systems or devices – Time interval – Electrical or electromechanical

Reexamination Certificate

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Details

C368S110000, C368S113000, C600S382000, C600S384000

Reexamination Certificate

active

06392962

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a method and an apparatus for aiding the treatment of sleeping disorders that are aggravated by an insomniac's underestimation of total sleep time and sleep efficiency and overestimation of time necessary to fall asleep.
BACKGROUND OF THE INVENTION
Statistics indicate that sleeping disorders such as insomnia plague a significant percentage of the worlds population. People with insomnia in the United States alone number in the millions. Although there are several types or classifications of insomnia or similar sleeping disorders and a variety of possible causes, many theories suggest that insomniacs are generally either physiologically or cognitively hyperaroused relative to normal sleepers. In essence, many clinical tests and studies indicate that a substantial subset of people who suffer from insomnia unintentionally promote their condition by the anxiety resulting from their knowledge or misconception that they cannot readily fall asleep. It has been demonstrated that insomniacs generally underestimate their total sleep time and, more particularly, overestimate the amount of time necessary for them to fall asleep. As a result, the insomniac's problem is perpetuated and causes the insomniac to feel tired the next day.
Common methods of treating insomnia involve the use of prescription drugs or sleep training exercises, or both. For many reasons, a successful sleep training method would be preferred over drug therapy. Thus, a method of sleep training that allows the insomniac to make accurate determinations of sleep onset and total sleep time could contribute to the successful reduction or cure of an individual's insomnia.
Chronic insomnia is a distressing complaint that affects a significant percentage of the world's population; 35 to 40 million in the United States alone. Chronic insomnia is believed to be a problem for 15 to 30 percent of the adult population and close to 65 percent for some special groups, such as shift workers and psychiatric patients. Prevalence rates are fairly similar among the countries where insomnia has been studied: England, Finland, Israel and Italy. The number of advertisements for hypnotic drugs in the scientific journals give some idea of the importance of this disorder as a medical problem.
Three general types of insomnia have been described: initial, or sleep onset; intermittent, or sleep maintenance; and terminal, or early morning awakening. Several studies suggest that insomniacs are either physiologically or cognitively hyperaroused relative to normal sleepers. Individuals who are highly aroused may experience difficulty in falling asleep or may awaken frequently at night because sleep is associated with low levels of autonomic arousal. Data from two separate studies support the hypothesis that physiological arousal or anxiety is an etiological factor in insomnia. Insomniacs also seem to be characterized by neuroticism, anxiety, or worry. The results of a complete evaluation of nearly 8000 patients in the Sleep Disorders Clinics (ASDC) across the United States support the conventional hypothesis that insomnia is caused by depression or stress. In essence, multiple clinical tests and studies indicate that many people who suffer from insomnia unintentionally promote their condition by anxiety resulting from their knowledge that they cannot readily fall asleep. A significant direct correlation has been found between the Manifest Anxiety Scale score and 1) time required to fall asleep, 2) number of times awake, 3) time required to go back to sleep and 4) report of sleep difficulties. Corresponding daytime complaints typically include fatigue, sleepiness, poor performance, aching muscles, anxiety and loss of concentration and memory. Chronic insomniacs are two and one-half times as likely as non-insomniacs to report vehicle accidents in which fatigue was a factor. One study presented evidence that the complaint of insomnia is an important mortality risk factor. Similarly, clinical experiences support two hypotheses: 1) poor sleep causes drowsiness, poor health and, hence, poor performance, or 2) the complaint of insomnia indicates a person with chronic psychological problems that extend beyond sleep.
Well over half of any large population of individuals who complain of insomnia are likely to be using one or more sedative drugs on a daily basis. Although only five percent of insomniacs actually have visited a health professional for their sleep problems, 28 percent use alcohol, 29 percent self-administer over-the-counter medications and 12 percent use both to try to get to sleep. The estimated cost for retail prescriptions of hypnotics in 1970 was $170 million and has increased significantly since that time. In 1991, for example, three sleeping pills, Halcion, Restoril, and Dalmane accounted for nearly 11 million prescriptions written.
Many hypnotic drugs are ineffective and may cause sleep alterations, especially if consumed in excessive doses over long periods. One study found that initially the following drugs: chloral hydrate, ethcloruznol, glutethimide, methaqualone, methaqualone HCl and secobarbital were moderately to markedly effective in inducing or maintaining sleep, or both. The study also found, however, that, at the end of a two week period of drug administration, a loss of effectiveness for sleep induction or maintenance, or both, had developed with all these drugs. It is at this danger point where patients begin to increase their dosage or use to try to maintain the same effect. Consequently, the widespread use of hypnotic medication has also made accidental overdosage in people using or abusing these drugs a substantial health hazard. Where drugs are correctly administered, withdrawal of rapidly eliminated benzodiazepine hypnotics can lead to a condition called rebound insomnia. With ultrashort half-life drugs, early morning insomnia, another withdrawal phenomenon, may occur even during administration.
Additionally, some of these drugs may have unwanted side effects. In 1990, when the Food and Drug Administration tallied the numbers of hostile acts reported in association with 329 different prescription drugs, Halcion ranked No. 1 followed by Xanax. Ideally, patients with disturbed sleep should be educated not only to the effectiveness and side effects of prescription drugs, but also to the adverse effects of stimulant pharmacologic agents: cigarette smoking, caffeinated beverages and alcohol.
The use of behavioral techniques in the treatment of insomnia is based on the premise that anxiety or heightened autonomic arousal is an etiological or maintaining factor. Behavioral methods have the additional benefits of the absence of adverse side effects and rebound effects associated with drug treatment. If heightened physiological arousal or anxiety inhibits sleep, reduction of anxiety or autonomic activity levels would logically facilitate sleep. In this regard, one of the more interested findings to come out of sleep research, is that insomniacs as a group significantly overestimate sleep latencies and underestimate total sleep and sleep efficiency. Overall assessment of sleep by the patient must depend partly on the patient's own estimate of sleep duration, which in turn depends on how long the patient takes to fall asleep and how often and for how long the patient remains awake during the night. If the patient is inaccurate in assessing these factors, then the insufficiency of the patient's sleep will, ipso facto, be exaggerated.
Following this line of reasoning, several studies suggest that relaxation, systemic desensitization, biofeedback, or other anxiety reducing procedures may be effective in the treatment of insomnia.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to apply behavioral techniques to the treatment of insomnia by correcting an insomniac's overestimation of sleep latency and underestimation of total sleep and sleep efficiency.
It is another object of the invention to provide a drug-free sleep training m

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