By Makayla Cordoza, PhD, RN; Steven Holfinger, MD, MS; Shalini Paruthi, MD, FAASM; Sachin Shah, MD, MS; Cameron Barber, DO; Evin Jerkins, DO; Jennifer Y. So, MD; Navin Verna, MD, FAASM; Sharon Schutte-Rodin, MD, FAASM; on behalf of the AASM Rising Expertise Committee
With the general public’s rising curiosity in sleep and exercise habits, the marketplace for actigraphy-based wearable gadgets designed to trace motion and estimate sleep has quickly expanded. For 2024, roughly 560 million wearable unit shipments had been anticipated, reflecting their growing relevance past sleep clinics to houses and the office. Actigraphy gadgets have developed considerably lately, incorporating further sensors reminiscent of photoplethysmography (PPG) alongside conventional triaxial accelerometers. Wearables sometimes worn on the wrist are additionally now accessible for the finger, arm and chest, providing prolonged monitoring of exercise and sleep. The extra incorporation of synthetic intelligence and multi-sensor algorithms to course of and interpret wearable information for each shoppers and clinicians has additionally enhanced the potential usefulness of those gadgets.
This text offers a broad overview of medical purposes for actigraphy-based wearables designed to be worn constantly (each day and night time), together with technical concerns and a abstract of some presently accessible gadgets. The AASM and authors haven’t any affiliation with any merchandise and don’t endorse any merchandise described right here.
Scientific gadgets for actigraphy in sleep drugs
Actigraphy is a necessary device in sleep drugs, notably for objectively evaluating sleep-wake patterns and aiding within the prognosis and the therapy monitoring of sleep problems. Widespread indications for actigraphy embrace its use previous to the A number of Sleep Latency Check (MSLT) when evaluating central problems of hypersomnolence to make sure inadequate sleep and circadian misalignment don’t confound the outcomes. Actigraphy is continuously used to evaluate circadian rhythm sleep-wake problems and to guage insomnia traits. Actigraphy may additionally be employed to watch the effectiveness of therapy interventions, reminiscent of response to cognitive-behavioral remedy for insomnia (CBT-I) or pharmacological therapies.
Choosing an applicable actigraphy machine includes a number of concerns reminiscent of:
Added options: Examples embrace temperature, PPG, gyroscope, microphone, the power to put on on completely different physique places, and different further options which may be of curiosity when selecting a tool.
Information outputs and experiences: Some wearable corporations provide the power to attain uncooked information, use open-source algorithms, create customized experiences and extra.
Distant monitoring options: Potential to view information in actual time (to offer rapid suggestions and monitor compliance) vs downloading information upon machine return.
Battery life: Reduce interruptions for required charging throughout monitoring.
System validation: Not all gadgets have validation research in opposition to polysomnography that verify accuracy and reliability for sleep indices. Issues embrace: (1) printed efficiency research, particularly what topics and information outputs the validation included (e.g., adolescents vs adults, sleep length, sleep staging, and many others.), (2) when FDA-clearance is required: use indications, inclusion/exclusions and predicate machine comparisons, and (3) upcoming and ongoing research, topics and outcomes from clinicaltrials.gov.
Particular populations: Correct information seize requires wearable gadgets to have an ample match to optimize utilization. Sizing limitations are a consideration for over/underweight and pediatric populations. The usability of the machine (e.g., display dimension, the necessity to navigate buttons, and many others.) can also be vital and inhabitants dependent.
Actigraphy efficiency and validation in pediatric populations current distinctive challenges. Youngsters’s exercise patterns and sleep structure differ from these of adults, necessitating tailor-made algorithms for correct evaluation. Research evaluating actigraphy to polysomnography in kids usually display settlement in measuring complete sleep time and sleep effectivity. Nonetheless, deciphering actigraphy motion after sleep onset as wake or sleep, particularly in kids with motion problems or developmental delays, presents efficiency challenges. Additional analysis is required to reinforce algorithm precision for pediatric populations and to make sure dependable ends in numerous medical contexts.
Billing and reimbursement for distant affected person monitoring (RPM) with actigraphy will depend on correct coding and compliance with insurance coverage necessities. Generally used billing codes embrace CPT 99453, 99454 and 99457, which cowl machine setup, information transmission and affected person interplay. Insurance coverage protection usually requires the usage of FDA-cleared gadgets and documented medical necessity. Reimbursement charges differ by state and insurer however are continuously accessible for pre-MSLT assessments, circadian rhythm evaluations, and pediatric monitoring when supported by ample documentation. Medicaid and personal insurers might cowl these providers, notably in the event that they align with telehealth and RPM insurance policies.
Client wearables
Competitors is excessive for shopper sleep gadgets, resulting in each fast technological developments and shortcomings in accessible information to guage machine efficiency. Shoppers have benefited from longer battery life, improved consolation, intuitive app interfaces and a current inflow of smartwatches/bands, rings and different wearables. Client sleep monitoring falls underneath the well being and wellness class, which doesn’t require FDA oversight. Shoppers depend on machine outputs with out a lot demand for efficiency metrics. For instance, many gadgets provide sleep staging with little validation of their accuracy exterior of laboratory settings. Most producers shield analytic algorithms, that means entry to uncooked information and inhabitants datasets are restricted. A number of publications have discovered shopper machine accuracy varies by machine and producer. When evaluating shopper machine efficiency for medical purposes you will need to contemplate the machine mannequin and software program model. For instance, machine efficiency from the identical producer might differ, and software program updates might alter accuracy.
A number of shopper corporations are transferring into the well being care area and re-marketing their gadgets for medical monitoring. For instance, Completely happy Ring was initially marketed as a shopper machine for temper and stress monitoring. It just lately rebranded as Completely happy Well being with the FDA-cleared Completely happy Ring for physiologic monitoring, together with sleep, as a part of its at-home well being monitoring platform. Different consumer-available actigraphy-embedded gadgets have acquired FDA clearance for sure physiologic monitoring (e.g., Masimo W1) and for sleep indications (e.g., Apple Watch and Samsung Galaxy Look ahead to sleep apnea detection).
Sensor evaluation
Actigraphy-based wearables use algorithms to determine points of sleep through the use of (at the very least) movement information from an accelerometer. A typical problem with accelerometry-based algorithms is the overestimation of sleep if the consumer is sedentary or lays nonetheless in mattress. Algorithms are additionally predominantly validated for nighttime sleep and are much less dependable for detecting daytime sleep.
Essentially, an accelerometer identifies spatial displacement, which is the idea for sleep-wake estimation. Further sensors like ambient gentle, physique temperature or PPG (which can be utilized to report coronary heart charge variability, respiratory charge and SpO2) can be utilized to enhance the sleep algorithm and supply extra information outputs. These parameters mixed with microphone evaluation create the potential for detection of further sleep problems.
Abstract
Actigraphy generally is a helpful medical device for distant and long-term sleep monitoring and for aiding within the prognosis and therapy efficacy for a lot of sleep problems. Developments in wearable applied sciences have revolutionized each shopper and medical purposes associated to assessing points of sleep and wake behaviors, sleep problems and monitoring therapies. There are actually quite a few choices for each shopper and medical actigraphy, with ongoing integration of added sensors, up to date algorithms/AI, and different capabilities. These developments include advantages and challenges for clinicians and researchers in each selecting a know-how to be used, information administration, prices, and in deciphering outcomes for sufferers. Importantly, unclear and restricted insurance coverage reimbursement for actigraphy presently limits routine integration in medical sleep and circadian care.
With the curiosity in sleep well being monitoring and FDA clearance from shopper wearables rising, an ongoing enhance within the variety of sufferers presenting with findings from their apps, wearables and nearables is probably going. Staying present with these quickly evolving shopper and medical sleep monitoring applied sciences, in addition to implementing medical apply integration, stays difficult. Associated AASM member assets embrace #SleepTechnology, Montage journal, Speaking Sleep, the AASM Interact members discussion board, publications (e.g., JCSM), programs (e.g., Sleep Drugs Traits, Sleep Drugs Disruptors and the SLEEP annual assembly), and plenty of web site hyperlinks.
Desk 1: Examples of business actigraphy gadgets supposed to be worn each day and night time that monitor sleep/wake patterns
* All gadgets use triaxial accelerometers**All present entry to uncooked information until in any other case statedAbbreviations: Photoplethysmography (PPG), electrodermal exercise (EDA), inertial measurement unit (IMU), psychomotor vigilance take a look at (PVT)
