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Medical Policy | ||
| Subject: Diagnosis of Sleep Disorders | |||
| Policy #: MED.00002 | Current Effective Date: | 11/13/2006 | |
| Status: Reviewed | Last Review Date: | 09/14/2006 | |
Description/Scope
This policy addresses home/portable sleep studies, multiple sleep latency testing (MSLT), and other services for the diagnosis of sleep disorders including : (1) “nap” studies; (2) actigraphy, including use of static charge sensitive beds; (3) diagnostic audio recording, with or without pulse oximetry, to document sleep apnea (including SNAP® testing); (4) maintenance of wakefulness testing (MWT); and (5) topographic brain mapping.
Note: For information related to other technologies utilized in the diagnosis and management of sleep-related disorders, please see:
Policy Statement
A. Home/Portable Sleep Studies
B. Multiple Sleep Latency Testing (MSLT) and Maintenance of Wakefulness Testing (MWT)
C. Other Services
Rationale
Based upon the available, peer-reviewed literature, in-laboratory attended polysomnography (PSG) is considered the gold standard for diagnosis of sleep-related disorders, including, but not limited to, obstructive sleep apnea, narcolepsy, nocturnal myoclonia and for titration of Continuous Positive Airway Pressure (CPAP). Multiple randomized clinical trials have established that a standard PSG should include the measurement of O2 saturation, electrocardiography (EKG, ECG), electroencephalography (EEG), electromyography (EMG), electrooculography (EOG), airflow, and respiratory effort measurements. Exclusion of any of these measurements may lead to missing vital data needed to diagnose sleep disorders.
There is some controversy in the literature regarding the appropriateness of portable sleep monitors, in lieu of standard polysomnography, in the diagnosis of obstructive sleep apnea, and whether or not home-based studies are reliable. The American Academy of Sleep Medicine, American College of Chest Physicians, and American Thoracic Society have performed an extensive evidence based evaluation; which does not support the use of a home or portable sleep study in lieu of standard polysomnography. However, they acknowledge that it may be acceptable to perform a Type 3 study (preferably attended) in the home in the absence of the availability of standard polysomnography. (This is discussed in more detail in the home/portable sleep studies policy section above.)
The available evidence in the medical literature is sufficient to recommend the use of Multiple Sleep Latency Testing (MSLT) with polysomnography for the diagnosis of narcolepsy, or suspected idiopathic hypersomnia. The information gathered during this type of testing is vital for diagnosis of these conditions and is not available from other testing methods. While there is sufficient evidence to recommend that polysomnography be done prior to a MSLT, there is not adequate information regarding how soon after polysomnography the MSLT may be done. For the sake of convenience, it is common practice for the MSLT to be done immediately following the polysomnography and if not possible, the MSLT should be done within a reasonable time afterward. However, the use of MSLT as the sole diagnostic tool or performed routinely, in addition to polysomnography for the diagnosis of sleep apnea or for sleepiness associated with conditions other than narcolepsy or idiopathic hypersomnia, is not supported by evidence in the medical literature.
The utility of the maintenance of wakefulness test (MWT), in terms of improved health outcomes, has not been established. 2005 Practice Parameters published by the Standards of Practice Committee of the American Academy of Sleep Medicine (AASM) note there are no standard or generally accepted guidelines for the performance of an MWT, and several variations in protocol exist, based on differences in definitions of sleep onset , trial duration and the need for previous night polysomnography. Normative data, sensitivity and specificity data in various patient groups are also lacking. Nevertheless, one suggested use has been testing an individual’s ability to stay awake when public or personal safety issues are involved. However, the predictive value of MWT in this setting has not been established, and test results may not translate into behavior in workplace situations. Another potential use might be assessing the response to various treatments for disorders, such as sleep apnea or narcolepsy. However there are no established levels to indicate what represents a significant change in the test findings. Also, it is unclear that testing would provide useful information, over and above the patient’s clinical response to therapy in these disorders, or would influence clinical decision-making, thereby improving patient health outcomes. The AASM concludes, “Future research is needed to define normative values using rigorous methods, to identify the impact of a standard clinical protocol for MWT, and to correlate the degree of sleepiness on objective testing with safety and occupational risks for the individual and for society in ‘real life’ circumstances."
The evidence in the medical literature does not support the use of single nap studies. This type of study has not been proven to meet the standards and capabilities of sleep studies conducted in a formal sleep laboratory. Wide deviations in the conditions and data collection methods available in these types of studies cause too much variability in the result quality for proper sleep assessment. Additionally, nap sleep is not physiologically the same as nighttime sleep, and does not adequately reflect the range of sleep phases required for proper diagnosis, so results are not accurate when compared to full polysomnography.
While the use of actigraphy has been demonstrated to be useful in the detection of sleep problems in “healthy” individuals, potential benefits for patients with suspected sleep disorders have not been shown. The current body of evidence supporting the use of actigraphy for patients with sleep disorders is insufficient to allow adequate conclusions regarding efficacy.
The potential benefits of diagnostic audio recording, used alone or in conjunction with pulse oximetry, has not been demonstrated to provide clinical benefits equivalent to the currently accepted standard of care, polysomnography. While such methods do potentially identify occurrences of sleep apnea, other aspects of physiological functioning are not recorded simultaneously, thus providing an incomplete clinical picture and allowing the possibility of misdiagnosis.
Topographic brain mapping has been briefly described in the evaluation and diagnosis of OSA. However, the evidence is limited to small case series studies that do not allow full evaluation of this technology. At this time, the level of evidence supporting topographic brain mapping is insufficient to make any recommendations.
Background/Overview
Description of Sleep Disorders
Sleep disorders are some of the most common medical problems in the United States and have a significant impact on quality of life, productivity, and health. There are many different types of sleep-related disorders, including sleep apnea, upper airway resistance syndrome, insomnia, narcolepsy, nocturnal movement disorders, such as Restless Leg Syndrome (RLS) and Periodic Limb Movement Disorder (PLMD), unexplained excessive daytime sleepiness, and arousal disorders (parasomnias). Most, if not all, of these sleep-related disorders are treatable if diagnosed properly.
Sleep disorder studies, including polysomnography and multiple sleep latency testing, are used to determine or confirm a diagnosis related to sleep disturbances. These tests monitor various bodily functions including heart and respiratory rate, body position and movement, to gain an understanding of the conditions under which sleep disturbances occur. Obstructive sleep apnea represents a very large portion and is the focus of this policy. Another type of sleep disturbance is simply known as “apnea” or “central apnea.” This condition, caused by problems in the central nervous system, is unrelated to obstructive sleep apnea and is not addressed in this policy .
A Multiple Sleep Latency Test (MSLT) consists of four or five nap opportunities to determine both severity of sleepiness and presence of sleep onset rapid eye movement (REM) periods. The presence of sleep onset REM (also known as SOREM) in a nap, as well as the number of naps in which sleep onset REM is detected are recorded as well. For correct interpretation, the MSLT must be performed following an all-night polysomnogram. The patient is given the opportunity to nap at scheduled intervals for 20 minutes. Sleep is monitored and the sleep onset (if sleep occurs) is determined by the first EEG appearance of any stage of sleep, including stage 1 sleep. The sleep latency is the time interval from the onset of the nap to the onset of sleep on the monitored EEG. The Mean Sleep Latency is then determined by calculating the mean of the sleep latencies of the nap opportunities.
Many other tests have been proposed as alternatives to PSG and MSLT tests for the diagnosis and follow-up of sleep disorders. These tests include “nap studies,” actigraphy, diagnositic audio-taping, MWT, and topographic brain mapping. These tests are not currently recommended by any authoritative specialty medical organization for this purpose.
Proposed Benefits
The goal of all sleep disorder diagnostic procedures is to correctly identify a specific sleep disorder(s), in order to render proper treatment(s). Such treatment may alleviate sleep disorder symptoms and/or causes and allow a patient to achieve healthy sleep patterns.
Potential Risks
There are few, if any, risks associated with diagnostic tests for sleep apnea, although the use of non-standard testing may lead to inaccurate diagnosis and less than optimal treatment.
Definitions
Actigraphy: a method used to study sleep-wake patterns and circadian rhythms by assessing a patient’s movement over a period of time; measurements usually involve the detection of wrist movements.
Apnea: transient period where breathing ceases.
Apnea-Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI): a measure of apnea severity defined by the total number of episodes of apnea or hypopnea during a full period of sleep divided by the number of hours asleep; for the purposes of this policy, the terms AHI and RDI are interchangeable, although they may differ slightly in clinical use; an AHI/RDI greater than 30 is consistent with severe obstructive sleep apnea. In some cases, respiratory effort-related arousals (or RERAS) are included in the RDI value. These RERA episodes represent EEG arousals associated with increased respiratory efforts but do not qualify as apneic or hypopneic episodes because of the absence of their defining air flow changes and/or levels of oxygen desaturation.
Continuous Positive Airway Pressure (CPAP): a noninvasive treatment for sleep apnea that involves delivery of pressurized air during sleep through a device that snugly covers the nose; the appropriate setting for standard CPAP treatment is determined during a titration sleep study.
Epworth Sleepiness Scale (ESS): a standardized measure of the degree of a patient’s sleepiness.
Excessive daytime sleepiness: a condition where a person feels very drowsy during the day, even after getting adequate night time rest, and has a tendency to fall asleep or requires extra effort to avoid sleeping in inappropriate situations such as at work or driving; also defined as a score greater than or equal to 10 on the Epworth Sleepiness Scale.
Home Diagnostic Audio Recording (SNAP®Testing): a diagnostic test proposed for home use which may be self-administered; this test involves an audio recording of a sleeping patient, sometimes accompanied by pulse oximetry; the results may be analyzed by a computer.
Home/portable sleep study: (may also be known as NightWatch™ System, AutoSet® Recorder, Morpheus™ System) a diagnostic test proposed for home use which may be self-administered or attended by a technician; the machine is returned to the doctor the following morning for data analysis.
Hypopnea: breathing that is shallower, and/or slower, than normal.
Maintenance of Wakefulness Test (MWT): a laboratory-based test intended to measure the physiological sleep tendency under standardized conditions in the absence of external alerting factors. The MWT measures the ability to stay awake for a defined period of time, (generally a 40 minute protocol is used), with the first epoch of sleep as the definition of sleep onset.
Multiple Sleep Latency Test (MSLT): a test used in conjunction with polysomnography to determine the presence and severity of sleepiness; during this test the patient is given the opportunity to take naps at specified time intervals; the test consists of four or five nap opportunities at two hour intervals; each nap opportunity is 20 minutes in duration; patients with excessive daytime sleepiness may fall asleep almost immediately, while those without excessive sleepiness may not fall asleep at all; severe sleepiness is usually associated with an MSLT mean sleep latency of less than 5 minutes; the presence of sleep onset rapid eye movement (REM) and the number of naps in which sleep REM occurs is also determined.
Nap study: a shorter daytime version of a polysomnography sleep study.
Narcolepsy: a neurological condition, where patients experience profound daytime sleepiness; it may also include sudden, periodic, and transient loss of muscle tone associated with extreme emotions, such as laughter or anger (cataplexy).
Obstructive sleep apnea (OSA): a form of sleep disturbance, which occurs as the result of a physical occlusion of the upper airway during sleep, interfering with normal breathing; the occlusion is usually in the form of the back of the tongue and/or flabby tissue in the upper airway; this condition is associated with frequent awakening and often with daytime sleepiness.
Shift Work Sleep Disorder (SWSD): a sleep disorder related to unusual or constantly changing work schedules resulting in symptoms of insomnia or excessive sleepiness.
Sleep disorder: a disruptive pattern of sleep that may include difficulty falling or staying asleep, falling asleep at inappropriate times, excessive total sleep time, or abnormal behaviors associated with sleep.
SNAP® testing: see "home diagnostic audio recording".
Split-night study: a combination sleep study where the first half of the night is a polysomnography study; if the study indicates obstructive sleep apnea, the second half of the study is used for a CPAP evaluation and titration.
Upper airway: the area of the upper respiratory system including the nose, mouth and throat.
Coding
The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
A. Home or Portable Sleep Studies
B. Multiple Sleep Latency (MSLT) and MAintenance of Wakefulness (MWT) Testing
C. Other Services
References
Government Agency, Medical Society, and Other Authoritative Publications:
Web Sites for Additional Information
Index
Apnea/Hypopnea Index (AHI) Policy History
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