Medicine Section - Actigraphy

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

Description

Actigraphy refers to the assessment of activity patterns by devices used to record body movement. Actigraphy has been used for over two decades as an outcome measure in sleep disorders research (i.e., insomnia, circadian rhythm disorders,  sleep-related breathing disorders, restless leg syndrome, and periodic limb movement disorder).  Actigraphy devices are typically placed on the wrist and are worn continuously for at least 24 hours.  The activity monitors may also be placed on the ankle for the assessment of restless leg syndrome, or on the trunk to record movement in infants.  Activity is usually recorded  for three days or more, and can be collected continuously over extended time periods with regular downloading of data onto a computer for display and analysis.  The algorithms for detection of movement are variable among devices and may include “time above threshold,” the “zero crossing method,” or digital integration” method, resulting in different sensitivities.  The digital integration method reflects both acceleration and amplitude of movement; this form of data analysis may be most commonly used today.  Data on patient bed times (lights out) and rise times (lights on) are entered into the record from daily patient sleep logs or by patient-activated event markers.  Proprietary software is then used to calculate periods of sleep based on the absence of detectable movement along with movement-related periods of wake.  In addition to providing graphic depiction of the activity pattern, device-specific software may analyze and report a variety of sleep parameters including sleep onset, sleep offset, sleep latency, total sleep duration and wake after sleep onset.

There are numerous actigraphy devices that have received U.S. Food and Drug Administration (FDA) approval through the 510(k) process.

Policy/Criteria

Actigraphy is considered investigational as a technique to record and analyze body movement, including but not limited to its use to evaluate sleep disorders.

Scientific Background

This policy is based primarily on 2003 practice parameters issued by the American Academy of Sleep Medicine (2) with a further literature review conducted for the period of April 2002 through September 2005 to identify any additional published studies.

American Academy of Sleep Medicine Practice Parameters
In a review paper that served as the basis for the practice parameters, (3) the American Academy of Sleep Medicine pointed out the challenges in evaluating the diagnostic performance of actigraphy:

• Different actigraphy devices use different algorithms for the evaluation of data. There are no published articles comparing the different algorithms, making comparison between studies difficult.
• Polysomnography (PSG) is considered the gold standard for the evaluation of sleep/wake cycles. However, correlation data may be misleading. For example, a high correlation on total sleep time would mean that individuals who slept longer by PSG criteria also slept longer by actigraphy criteria, however, this would not exclude the possibility that actigraphy data overestimated total sleep time. Different methods of analysis have also been used such as accuracy for identification of true sleep and true wake epochs. The diagnostic performance will also vary according to how much time the patient is asleep. For example, malfunctioning records will falsely identify the patient as asleep. Finally, comparisons between PSG and actigraphy have to be time locked; if the 2 technologies gradually drift apart, different time epochs may be compared with each other.
• Published reports of actigraphy must contain complete reporting of sensitivity, specificity, and scoring algorithm, as well as reliability, validity, ruggedness, and artifact rejection for the device and computer program used.

The recommendations of the American Academy of Sleep Medicine are categorized as standards, guidelines, or options. Standards describe a generally accepted patient care strategy, which reflects a high degree of clinical certainty. Guidelines reflect a moderate degree of clinical certainty, while options imply either inconclusive or conflicting evidence or conflicting expert opinion. As noted here, there is only one recommendation considered a standard, and this addresses the technical performance of actigraphic devices (first bullet below). There is also only one recommended guideline (second bullet below), and this addresses the small subset of patients with insomnia and restless legs syndrome with specific indications. All of the other recommendations are considered options.

Recommendations of the American Academy of Sleep Medicine:

• Actigraphy is reliable and valid for detecting sleep in normal, healthy adult populations. (Standard)
• Actigraphy is not indicated for the routine diagnosis, assessment of severity or management of any of the sleep disorders. However, it may be useful in the assessment of specific aspects of insomnia (assessment of sleep variability, measurement of treatment effects, detection of sleep phase alterations) and restless legs syndrome/periodic limb movement (assessment of treatment effects). (Guideline)
• Actigraphy may be a useful adjunct to a detailed history, examination, and subjective sleep diary for the diagnosis and treatment of insomnia, circadian-rhythm disorders, and excessive sleepiness under certain conditions. (Option)
• The use of actigraphy may be useful in assessing daytime sleepiness in situations where a more standard technique, such as a multiple sleep latency test, is not practical. (Option)
• Actigraphy is an effective means of demonstrating multi-day human rest-activity pattern in clinical situations in which a sleep log, observations, or other methods cannot provide similar information. (Option)
• Actigraphy may be useful in characterizing and monitoring circadian rhythm patterns or disturbances in elderly and nursing home patients, newborns, infants, children, and adolescents; hypertensive individuals; depressed or schizophrenic patients; and individuals in inaccessible situations (i.e., space flight). (Option)
• Actigraphy appears useful as an outcome measure in interventional trials in patients with sleep disorders, outcome studies of healthy adults, patients with certain medical and psychiatric conditions, and children and the elderly. (Option)
• Actigraphy may be useful in determining the rest-activity pattern during portable sleep apnea testing. However, the use of actigraphy alone in the detection of obstructive sleep apnea is not currently established. (Option)
• Actigraphic studies should be conducted for a minimum of 3 consecutive 24-hour periods, but this length of time is highly dependent on the specific use in a given individual. (Option)

Translated into an evidence-based policy, these practice parameters suggest that all indications for actigraphy would be considered investigational, as all the specific clinical indications for actigraphy are classified as guidelines or options. The parameters suggest that actigraphy could be used to evaluate specific aspects of insomnia. However, review of the literature cited by the American Academy of Sleep Disorders for this indication did not identify any controlled studies of actigraphy vs. PSG or other techniques. Indeed, all but 1 of the studies cited were classified as either 4C or 5D, indicating that the study was not blinded or prospective. One study was designated as 2B, indicating a blinded, prospective comparison, however, in this study actigraphy was used as an intermediate outcome measure in an investigation of bright lights as a treatment of delayed sleep phase syndrome. (3)

Additional Literature Search

The literature reviewed focused on additional randomized studies comparing the results of actigraphy to either polysomnography (PSG), to determine whether actigraphy could be considered an alternative to PSG, or studies comparing actigraphy to other methods, such as sleep diaries or direct observation, to determine whether actigraphy could provide incremental information that would result in an improvement in patient management. The literature search revealed that actigraphy is frequently used as an intermediate outcome in research studies, but there were no randomized studies identified that focused on the use of actigraphy to either diagnose or direct the management of patients with sleep disorders. For example, actigraphy has been used as an intermediate outcome in several trials of melatonin for sleep disturbances in patients with Alzheimer’s disease (4-6) or other drug trials. (7)

A literature review conducted in September 2006 did not find any studies that would change the conclusions noted above.  A 2005 Update for the AASM Practice Parameters (9) continues to list actigraphy as an option and suggests areas, such as restless legs syndrome and characterizing circadian rhythm patterns, for further evaluation.  No controlled studies have been conducted to compare the results of actigraphy to other methods to determine if actigraphy would provide incremental information that would result in changes in patient management decisions and improved health outcomes.

2007 Update

A search of the MEDLINE database was performed through September 2007.  No studies were identified to evaluate if the use of actigraphy would result in improved health outcomes for patients with sleep disorders.  One study assessed the sensitivity and specificity of actigraphy in comparison with PSG in older adults treated for chronic primary insomnia. (10) Visual scoring of the PSG data was blinded and actigraphic records were scored by proprietary software.  The study found that actigraphy agreed with PSG scoring of sleep for 95% of the 30-second epochs (sensitivity), but agreed with PSG scoring of wake only 35% of the time (specificity).  The authors conclude that, “the clinical utility of actigraphy is still suboptimal in older adults for chronic primary insomnia.”

Another study examined the validity of actigraphy for determining sleep and wake in children with sleep disordered breathing with data analyzed over four separate activity threshold settings (low, medium, high, auto). (11) The low and auto activity thresholds were found to adequately determine sleep (relative to PSG), but significantly underestimated wake, with sensitivity of 97% and specificity of 39%.  The medium and high activity thresholds significantly underestimated sleep time, but were not found to be significantly different from the total PSG estimates of wake time.  Overall agreement rates between actigraphy and PSG (for both sleep and wake) were 85% to 89%.

The AASM Practice Parameters for the use of actigraphy in the assessment of sleep disorders were updated for 2007. (12) Although the 2005 update focused on the comparison of actigraphy with polysomnographically recorded sleep, the 2007 update included 108 additional studies comparing actigraphy to a number of standard clinical assessment tools including PSG, sleep logs, subjective questionnaires, care giver reports, and circadian phase markers.

Actigraphy was recommended as a “standard” only as a method to estimate total sleep time in patients with obstructive sleep apnea syndrome when PSG is not available.  Other indications changed from “option” to “guidelines”, but failed to reach a recommendation of “standard” due primarily to the absence of high-quality trials.  Few of the studies reviewed had provided technical details related to the administration and scoring of actigraphy.  In addition, most of the studies lacked a description of blinding, and there was “an inadequate description of whether visual inspection of data is performed, how missing data is handled, and other important decisions made in the analysis of actigraphy data.”

The AASM Standards of Practice Committee indicated the need for additional research in the following areas:

• Comparison of results from different actigraphy devices and the variety of algorithms used
• Standards for setting start and stop times
• Reliability and validity compared to reference standards
• Clarification of the relative and unique contributions of actigraphy, polysomnography and sleep logs in the diagnosis of sleep disorders and measurement of treatment effects.

2008 Update

An updated search of the MEDLINE database identified no studies that would alter the above policy conclusions. Studies continue to use actigraphy as a secondary outcome measure in sleep disorder research.  These trials do not provide direct information on use of actigraphy to diagnose or clinically manage patients with sleep disorders.

References

1. BlueCross and BlueShield Association, Medical Policy Reference Manual, Policy No. 2.01.73
2. Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for the role of actigraphy in the study of sleep and circadian rhythms: an update for 2002. Sleep 2003;26(3):337-41
3. Ancoli-Israel S, Cole R, Alessi C et al. The role of actigraphy in the study of sleep and circadian rhythms. Sleep 2003;26(3):342-92
4. Cole RJ, Smith JS, Alcala YC et al. Bright-light mask treatment of delayed sleep phase syndrome J Biol Rhythms 2002;17(1):89-101
5. Singer C, Tractenberg RE, Kaye J et al.A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer’s disease. Sleep 2003;26(7):893-901
6. Baskett JJ, Broad JB, Wood PC et al. Does melatonin improve sleep in older people? A randomized crossover trial. Age Aging 2003;32(2):164-70
7. Serfaty M, Kneller-Webb S, Warner J et al. Double blind randomized placebo controlled trials of low dose melatonin for sleep disorders in dementia. Int J Geriatr Psychiatry 2002;17(12):1120-7
8. Ruths S, Straand J, Nygaard HA et al. Effect of antipsychotic withdrawal on behavior and sleep/wake activity in nursing home residents with dementia: a randomized placebo-controlled, double-blinded study. The Bergen District Nursing Home Study. J Am Geriatr Soc 2004;52(10):1737-43
9. Kushida CA, Littner MR, Morganthaler T et al. Practice parameters for the indications for polysomnography and related procedures: an update for 2005. Sleep 2005;28(4):499-521
10. Silvertsen B, Ornvik S, Havik OE et al. A comparison of actigraphy and polysomnograph in older adults treated for chronic primary insomnia. Sleep 2006;29(10):1353-8
11. Hyde M, O’Driscoll DM, Binette S, et al. Validation of actigraphy for determining sleep and wake in children with sleep disordered breathing. J Sleep Res 2007;16(2):213-6
12. Morgenthaler T, Alessi C, Friedman L et al. Standards of Practice Committee: American Association of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep 2007;30(4):519-29

Cross References

None

Medicine Section Table of Contents