American Thoracic Society Documents

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1 American Thoracic Society Documents An Official American Thoracic Society Statement: Continuous Positive Airway Pressure Aherence Tracking Systems The Optimal Monitoring Strategies an Outcome Measures in Aults Richar J. Schwab, Safwan M. Bar, Lawrence J. Epstein, Peter C. Gay, Davi Gozal, Malcolm Kohler, Patrick Lévy, Atul Malhotra, Barbara A. Phillips, Ilene M. Rosen, Kingman P. Strohl, Patrick J. Strollo, Ewar M. Weaver, an Terri E. Weaver; on behalf of the ATS Subcommittee on CPAP Aherence Tracking Systems THIS OFFICIAL STATEMENT OF THE AMERICAN THORACIC SOCIETY (ATS) WAS APPROVED BY THE ATS BOARD OF DIRECTORS, MARCH 2013 CONTENTS Executive Summary Introuction Methos Committee Process Literature Search CPAP Aherence Tracking Systems CPAP Aherence Tracking Transmission Systems Barriers to Using CPAP Aherence Tracking Systems in Clinical Practice Metrics to Determine CPAP Effectiveness Future Directions: Research Strategies Neee to Aress CPAP Tracking an Outcomes Conclusions Backgroun: Continuouspositive airway pressure (CPAP) is consiere the treatment of choice for obstructive sleep apnea (OSA), an stuies have shown that there is a correlation between patient aherence an treatment outcomes. Newer CPAP machines can track aherence, hours of use, mask leak, an resiual apnea hypopnea inex (AHI). Such ata provie a strong platform to examine OSA outcomes in a chronic isease management moel. However, there are no stanars for capturing CPAP aherence ata, scoring flow signals, or measuring mask leak, or for how clinicians shoul use these ata. Methos: American Thoracic Society (ATS) committee members were invite, base on their expertise in OSA an CPAP monitoring. Their conclusions were base on both empirical evience ientifie by a comprehensive literature review an clinical experience. Results: CPAP usage can be reliably etermine from CPAP tracking systems, but the resiual events (apnea/hypopnea) an leak ata are not as easy to interpret as CPAP usage an the efinitions of these parameters iffer among CPAP manufacturers. Nonetheless, ens of the spectrum (very high or low values for resiual events or mask leak) appear to be clinically meaningful. Conclusions: Proviers nee to unerstan how to interpret CPAP aherence tracking ata. CPAP tracking systems are able to reliably track CPAP aherence. Nomenclature on the CPAP aherence tracking reports nees to be stanarize between manufacturers an AHI Flow shoul be use to escribe resiual events. Stuies shoul be This statement has an online supplement, which is accessible from this issue s table of contents at Am J Respir Crit Care Me Vol 188, Iss. 5, pp , Sep 1, 2013 Copyright ª 2013 by the American Thoracic Society DOI: /rccm ST Internet aress: performe examining the usefulness of the CPAP tracking systems an how these systems affect OSA outcomes. Keywors: CPAP aherence; sleep apnea; CPAP tracking systems EXECUTIVE SUMMARY Obstructive sleep apnea (OSA) is an extremely common conition an is associate with significant morbiity an mortality (1 18). Optimal treatment of sleep apnea is critical because sleepisorere breathing is associate with the increase risk of vehicular crashes an cariovascular morbiity an mortality (6, 9 18). Continuous positive airway pressure (CPAP) is the treatment of choice for sleep apnea (19 22). Increase CPAP aherence has been shown to improve outcomes such as aytime sleepiness, quality of life, an mortality (23 25). OSA shoul be consiere in a chronic isease management moel in which CPAP aherence is tracke over time. To assess CPAP aherence an efficacy, tracking systems have been implemente. Such systems monitor CPAP efficacy (resiual sleep-isorere breathing), hours of CPAP use, mask leak, an a number of ifferent flow signals. However, there are no stanars on how to use the ata from these new CPAP tracking systems nor o we have evience that these systems ultimately improve outcomes. See the online supplement for full iscussion of the literature on the accuracy of the resiual AHI an mask leak. The purpose of this ocument is to (1) review the ata (aherence, leak, efficacy, flow signals) obtaine from CPAP aherence tracking systems an the reliability of these ata; (2) examine the use of CPAP tracking systems in clinical practice; (3) iscuss outcomes that satisfy payer reimbursement criteria for chronic CPAP use; an (4) propose research questions to aress important issues in relation to CPAP tracking an OSA outcomes. Major conclusions of this clinical statement: CPAP aherence tracking systems intuitively seem useful; however, there are few stuies that provie ata that show that these systems improve CPAP usage or OSA outcomes. Notwithstaning, CPAP aherence tracking systems provie a strong platform to generate outcome ata in a chronic isease management moel, which is how the treatment of OSA shoul be consiere. CPAP usage can be reliably etermine from CPAP tracking systems (although there can be technical failures with car transmission of ata) an such ata shoul be routinely examine in patients with OSA. CPAP aherence nees to be monitore sequentially over time.

2 614 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL To optimally interpret resiual events on the CPAP aherence tracking reports, proviers nee to unerstan the ifferent efinitions for apneas an hypopneas from each manufacturer of CPAP tracking systems. The resiual apneas an hypopneas an mask leak ata from CPAP tracking systems are not easy to interpret an the efinitions of these parameters iffer among each of the CPAP aherence tracking system manufacturers. The value of CPAP aherence monitoring for clinical ecision making base solely on intermeiate values for the resiual apnea hypopnea inex (AHI), resiual apnea inex, or mask leak is unclear an, therefore, aitional research is inicate. Very high or low values for resiual apneas/hypopneas or mask leak appear to be clinically useful in chronically managing patients with sleep apnea. Current clinical care systems are not optimally configure for examining ata from CPAP aherence tracking systems. Documentation of CPAP aherence shoul be accepte between 7 an 90 ays, rather than the current 31- to 90-ay requirement, an CPAP aherence shoul be monitore long term (for as long as the patient is using CPAP). Nomenclature on the CPAP aherence tracking reports nees to be stanarize between manufacturers an AHI Flow shoul be use to escribe resiual events. Stuies shoul be performe to examine the usefulness of the CPAP tracking systems an how these systems affect OSA outcomes. INTRODUCTION Obstructive sleep apnea (OSA) is an extremely common conition an is associate with consierable morbiity an mortality. The Wisconsin Sleep Cohort Stuy foun that 4% of mileage males an 2% of mile-age females ha OSA (1). The prevalence of OSA is much higher (on the orer of 80%) in certain populations (overweight type 2 iabetics, bariatric surgery patients) (2 5). Consequences of OSA can be broaly ivie into those relate to neurocognitive function (e.g., excessive sleepiness) an those relate to the cariovascular an metabolic systems. Excessive aytime sleepiness prouces a number of ifferent problems for patients with OSA, the most serious of which is motor vehicular accients (MVAs). Stuies in riving simulators inicate that OSA impairs riving ability (6), an crashes are increase among iniviuals who have OSA compare with matche iniviuals who o not have OSA (7). Patients with OSA can be as impaire in riving skills as those who are over the legal bloo alcohol concentration limit (6). The Sleep Heart Health an other stuies have emonstrate that patients with OSA are at increase risk for hypertension (9 11), myocarial infarction (MI) (12, 13), stroke (14), an eath (15 18). Nocturnal cariac arrhythmias incluing atrial fibrillation, sinus braycaria/tachycaria, supra/ventricular tachycarias, heart block, an sinus pauses have all been reporte uring apneic episoes (26 29). Mil-to-moerate pulmonary hypertension can evelop in patients with OSA (30 32) although overt right heart failure is uncommon in the absence of other contributing factors. Stuies have shown that patients with moerate-to-severe OSA have increase mortality (10 to 20 yr after the iagnosis has been mae) (16 18). On the basis of the public health impact of the increase risk of vehicular crashes an the cariovascular morbiity an mortality, optimal treatment of OSA is clearly important. Continuous positive airway pressure (CPAP) is the treatment of choice for OSA (19 22). CPAP has been shown to improve sleep architecture, ecrease risk of MVAs (33 35), improve quality of life (23, 36), an ecrease neurocognitive an cariovascular consequences associate with OSA (12, 22, 37 47). Several consensus statements have examine the efficacy of CPAP in the treatment of OSA (22, 47, 48). Moreover, CPAP aherence (measure as hours of use per night) has been shown to moify outcomes (23 25). The importance of aherence to treatment has been shown by stuies showing the return of sleepiness an impairments in simulate riving ability in as little as one night off CPAP (49, 50). Moreover, CPAP withrawal resulte in a rapi recurrence of apneic events, aytime sleepiness, increase bloo pressure, an increase heart rate (51). To assess CPAP aherence an efficacy, tracking systems have been implemente by CPAP manufacturers. Such systems monitor CPAP efficacy (resiual sleep-isorere breathing), hours of CPAP use, mask leak, an a number of ifferent flow signals. However, there are no guielines on how to use the ata from these new CPAP tracking systems nor o we have evience that these systems ultimately improve outcomes. Furthermore, methos of measuring an reporting the parameters from CPAP aherence ownloas are inconsistent between manufacturers an not well valiate. CPAP aherence tracking systems are available to most proviers who care for patients with OSA. Yet there are few stuies examining the usefulness of CPAP tracking systems even though they arecommonlyuseinclinicalpracticetomanagepatientswith OSA (52). Technological avances rather than evience-base meicine are riving the increase use of CPAP tracking systems in this rapily changing environment. CPAP aherence tracking systems have not been teste to show improve outcomes but their use is intuitively logical, such that CPAP aherence tracking is now a requirement for Meicare an other payers to continue reimbursement for CPAP beyon the first 3 months of treatment. CPAP aherence tracking systems provie a strong platform to generate outcome ata in a chronic isease management moel, which is how the treatment of OSA shoul be consiere. We have the ability to link patterns of use to salient isease outcomes an responses to treatment. It is much easier to etermine CPAP aherence outcomes for OSA treatment than it is to etermine treatment outcomes for most chronic isorers incluing asthma, hypertension, arthritis, or chronic obstructive pulmonary isease. As such, the OSA fiel has the opportunity to take a leaing role in unerstaning interventions to improve aherence to therapy. Such strategies may be critical to improving clinical outcomes. We can track CPAP use in timeframes ranging from hours of use uring one night, to use over months to even years. This ability permits the linking of patterns of use to cariovascular outcomes an can help irect clinical ecision making. The goals of this statement are as follows: To review CPAP aherence tracking systems, incluing the ata that they track (aherence, leak, efficacy, flow signals) an the reliability of these ata. To examine the use of CPAP tracking systems in clinical practice. To iscuss clinical outcomes (CPAP usage an others) that coul be measure to satisfy payer reimbursement criteria for chronic CPAP use. To aress important research questions in relation to CPAP tracking an OSA outcomes.

3 American Thoracic Society Documents 615 METHODS Committee Process The Statement was conceive by the planning committee of the Sleep an Respiratory Neurobiology Assembly of the ATS, an was chair (Richar J. Schwab) initiate. Committee members were invite on the basis of their scientific/clinical expertise in investigation/management of OSA an CPAP monitoring. Most of the committee members were from acaemic institutions within the Unite States, because the focus of this ocument was irecte towar proviers within the Unite States. Meetings were hel at the American Thoracic Society annual international conference an consensus on all conclusions was reache among members of the committee by iscussion. All members reviewe an approve the entire final raft by . All committee members were require to isclose potential conflicts of interest, which were vette accoring to the policies of the ATS. See METHODS TABLE in the online supplement. Literature Search Committee members compile reference material germane to the assessment of CPAP monitoring, aherence, an outcomes in OSA. In aition, a literature review was conucte, base primarily on PubMe (from 2000 to November 2012), meical library catalog searches, an manual reviews of the bibliographic an abstract sections for the annual meetings of the American Thoracic Society, the Associate Professional Sleep Societies, other relevant professional societies, an reference lists of selecte papers an chapters. Key wors for the literature search inclue the following: CPAP aherence tracking systems, CPAP aherence, CPAP compliance, CPAP use, an CPAP tracking systems. This clinical statement focuse on peer-reviewe articles, reviews, an eitorials, in which primary ata, conclusions, an/ or positions were available. However, because there were sparse primary ata on CPAP aherence tracking systems, conclusions were primarily base on uncontrolle observations an the clinical experience of our expert committee. CPAP ADHERENCE TRACKING SYSTEMS Why o we care about CPAP aherence an hours of use? Although CPAP improves both the neurobehavioral (aytime sleepiness [23, 24, 41, 42], MVA [33 35, 53]) an cariovascular consequences of OSA (hypertension [9 11, 39, 40, 43, 44, 46 48], MI [12, 13], stroke [14], atrial fibrillation [26 29]), the important question is whether or not increase CPAP hours of use further improve these outcomes. Weaver an colleagues an Antic an colleagues have inepenently shown that increasing the number of hours of CPAP use results in better outcomes (23, 24). Specifically in these stuies, increase hours of CPAP use improve measures of aytime sleepiness (e.g., the Epworth Sleepiness Scale [ESS], the Multiple Sleep Latency Test [MSLT], an scores in the Functional Outcomes of Sleep Questionnaire [FOSQ]). Likewise, cariovascular an mortality outcomes correlate with the amount of CPAP use (12, 25, 54 56). Thus, it is important to track CPAP use so that patients with OSA who use their evice for only a short uration may be intervene on. Objectively measure CPAP aherence is more reliable than self-reporte aherence, because self-reporte CPAP use has been shown to correlate poorly with actual hours of use (57). Refill rates of CPAP accessories have also be use as a surrogate measure for long-term CPAP aherence (58) but such ata may be more ifficult to obtain than CPAP aherence ownloas. These tracking systems can be use in patients receiving conventional CPAP; auto-cpap; or bilevel, auto-bilevel, or aaptive servo-ventilation. The specific pressure ata reporte in each of these systems iffer, but regarless of the type of positive airway pressure unit the reports provie information on aherence, resiual AHI, an mask leak. Table 1 reviews the aherence ata that can be tracke from CPAP units, Table 2 (52, 59 62) examines the specific event etection methoology for each CPAP manufacturer, Table 3 (63) efines how leaks an large leaks are measure, an Figure 1 provies a clinical algorithm for the use of CPAP aherence ata. The specific etails regaring performance evaluation of CPAP evice erive ata are escribe extensively in the online supplement. CPAP ADHERENCE TRACKING TRANSMISSION SYSTEMS There are several ifferent methos to transmit CPAP aherence tracking ata. Most systems use cars (smart cars or SD cars), memory sticks, or wireless transmission. Several stuies (64, 65) have emonstrate that these transmission systems may be better than routine practice (see the online supplement for etails about these stuies). Although wireless transmission of CPAP aherence ata is the future, a major problem with wireless systems is having the resources to retrieve the ata. It is not clear how, when, an who shoul monitor the wireless transmissions. Furthermore, there are known problems with loss of ata an failure of recoring systems (primarily smart cars) to further confoun tracking systems (66). The electronic transfer of the CPAP aherence monitoring reports also raises privacy an safety issues. Health Insurance Portability an Accountability Act (HIPAA) violations coul easily occur with these reports whether they are faxe or transmitte wirelessly. Moreover, a robust level of information security is require for transmission, storage, an access of the ata an at the website where the ata resie. Systems nee to be evelope to protect patient privacy when CPAP aherence ata reports are reviewe an maintaine on servers. BARRIERS TO USING CPAP ADHERENCE TRACKING SYSTEMS IN CLINICAL PRACTICE There are other barriers to incorporating CPAP aherence tracking systems routinely in clinical practice. The lack of stanarization preclues interoperability with existing electronic meical recors. Data profiles are not stanarize between the ifferent proprietary tracking systems an the reports are not yet easily exportable to electronic meical recors (presently the reports nee to be scanne into electronic meical recors, which takes time). Customize software shoul be written to allow more transparent input of CPAP aherence ata to a given electronic meical recor. Connectivity to server atabases can be suboptimal (particularly when using multiple homecare proviers an evice companies). Current care elivery systems are not configure for this type of ata management an examining the CPAP tracking reports can slow own patient flow in a busy sleep practice. Faxe reports are cumbersome an provie a black-an-white backgroun, which is problematic becausemanyofthereportsneetobeisplayeincolor. TABLE 1. ADHERENCE DATA DERIVED FROM CONTINUOUS POSITIVE AIRWAY PRESSURE TRACKING SYSTEMS Date ranges of evice usage Total number of nights the CPAP was use Total number of nights the CPAP was not use Percentage of nights with CPAP usage Percentage of nights with CPAP usage > 4 h/night Percentage of nights with CPAP usage, 4 h/night Average usage on nights when CPAP was use Average usage on all nights Definition of abbreviation: CPAP ¼ continuous positive airway pressure.

4 616 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL Figure 1. Clinical algorithm for using continuous positive airway pressure aherence tracking systems. There are also possible meical/legal ramifications of CPAP tracking systems. For instance, if a school bus river is using CPAP an has a motor vehicle accient, CPAP tracking ata coul be examine uring a legal proceeing. The bus river s CPAP use the night before an accient coul be examine as well as CPAP use uring the week before the motor vehicle accient. The physician taking care of this bus river coul also face meical/legal risk. If the bus river s CPAP use was not ieal, if there was a high resiual AHI or a large CPAP mask leak, it coul be argue that the physician shoul have acte on these ata. However, in such a scenario it is not clear how much CPAP use is enough or what level of resiual AHI matters. METRICS TO DETERMINE CPAP EFFECTIVENESS Although there are important concerns with CPAP tracking systems, thir-party payers are manating the use of CPAP aherence tracking systems to objectively ocument therapeutic use to reimburse CPAP. The Centers for Meicare an Meicai Services (CMS) have evelope specific guielines on CPAP (or bilevel) reimbursement. Initial CPAP reimbursement is limite to 12 weeks (67). Continue coverage of a CPAP evice beyon the first 3 months of therapy requires that, no sooner than Day 31 but no later than Day 91 after initiating therapy, the treating physician must conuct a clinical reevaluation an ocument that the patient is benefiting from CPAP therapy. Clinical benefit is emonstrate by a face-to-face clinical reevaluation by the treating provier with ocumentation that symptoms of OSA are improve with objective evience of CPAP aherence. Aherence is efine as use of CPAP for at least 4 hours/night on 70% of nights uring a consecutive 30-ay perio any time uring the first 3 months of initial usage. However, there is insufficient evience to support this efinition of CPAP aherence as a threshol for improve neurocognitive an cariovascular outcomes. As escribe previously, there is a ose response relationship between amount of nightly CPAP use an clinical outcomes (23 25). These ata inicate that even subjects who use CPAP for only 2 hours show improvement in measures of some outcomes (ESS, FOSQ, MSLT). Moreover, several stuies (some ranomize controlle trials) have shown improvements in aytime sleepiness, functional outcomes, cognitive function, an bloo pressure in patients treate with CPAP for less than 4 hours/night, 70% of the nights (23, 44, TABLE 2. EVENT DETECTION ALGORITHMS Manufacturer Apnea Event Detection Hypopnea Event Detection ResMe unit (S9 moel) Phillips Respironics unit (System One moel) DeVilbiss Healthcare IntelliPAP unit (SmartCoe remote ata retrieval system) Fisher & Paykel InfoSmart software Apnea is efine when the 2-s moving average root mean square ventilation (base on a pneumotachograph) falls below 25% of the long-term ventilation for 10 s Apnea is etecte after a moving winow of 3-4 min is establishe an flow ecreases by more than 80% for at least 10 s A reuction in a flow signal of.90% of the baseline flow for 10 s.80% reuction in flow relative to a baseline etermine from previous breaths Hypopnea is efine when all of the following conitions are met: 1. The 12-s moving average root mean square ventilation falls below 50% of the long-term ventilation 2. The hypopnea is not immeiately followe by an apnea 3. The hypopnea contains one or more partially obstructe breaths Hypopnea is etecte when moving winow of 3-4 min is establishe an flow ecreases by 40 80% for at least 10 s A reuction in a flow signal of.50% of the baseline flow for 10 s.40% reuction in flow relative to a baseline etermine from previous breaths

5 American Thoracic Society Documents 617 TABLE 3. CONTINUOUS POSITIVE AIRWAY PRESSURE MASK LEAK MEASUREMENTS CPAP Manufacturer How Leak Is Measure Large Leak Threshol Phillips Respironics ResMe Intentional leak subtracte from total flow Unintentional leak (evice flow-intentional leak) 1 mouth leak Leak conition where the leak level excees a preset flow vs. pressure curve (the average leak through all mask exhalation ports at various pressure) 95th percentile leak (,24 L/min with nasal interface an,36 L/min with full face interface) A leak value of.60 L/min Fisher & Paykel Total leak, incluing mask an exhaust flow from mask DeVilbiss Recors high leak flow time as A leak value of.95 L/min Healthcare a percentage of the time the IntelliPAP leak was above 95 L/min Definition of abbreviation: CPAP ¼ continuous positive airway pressure ). The CMS criteria assume that CPAP treatment has a threshol effect an therefore o not aress whether outcomes may have a linear response with much lower levels of CPAP use (23). The CMS requirements also manate an in-laboratory polysomnogram if CPAP was prescribe on the basis of portable monitoring an the patient subsequently fails the 90-ay use criteria. The valiity of this requirement is unclear, especially in the patient whose portable stuy emonstrates unequivocal severe OSA. What specific clinical outcomes inepenent of the ata from CPAP tracking systems shoul be measure to ascertain a salutary response to CPAP? Such outcomes coul inclue (1) subjective aytime sleepiness (ESS [it shoul be note, however, that the ESS is highly variable when aministere sequentially to a clinical OSA population (70)], etc.); (2) objective aytime sleepiness (PVT [Psychomotor Vigilance Test], MSLT, MWT [Maintenance of Wakefulness Test]); (3) self-reporte improvement in the presenting symptom (i.e., nocturia, heaache, sleep fragmentation, insomnia); (4) bloo pressure; (5) cariovascular outcomes (MI, hypertension, cariovascular accient, heart failure, arrhythmias, improve insulin resistance or iabetic control); (6) cognitive functioning (memory, neurocognitive testing); (7) quality of life (FOSQ, SF [Short Form Health Survey] 36, Calgary Sleep Apnea Specific Quality of Life Instrument [SAQLI] [71, 72], epression scales); (8) sexual function; (9) spousal outcomes; an (10) MVAs. It is likely that specific outcomes (e.g., cariovascular vs. cognitive) in various populations (e.g., ol vs. young, etc.) will be epenent on a range of CPAP urations. We believe optimal clinical practices (largely base on clinical experience) for chronically managing CPAP in patients with OSA shoul inclue the following: We encourage patients to use CPAP whenever they are asleep (uring the ay or night). We consier patients aherent if they regularly use CPAP for more than 4 h/night or if they use CPAP for more than 2 h/night an are making progress towar improve aytime sleepiness as measure by the ESS, subjective improvement in quality of life, or improvement of other OSA-associate health impairments (e.g., iabetes, hypertension). This reflects our belief that partial use is better than no use, although our goal is always to achieve full-time CPAP use uring sleep. We assess these outcomes soon after the initiation of CPAP therapy, because ata emonstrate that CPAP aherence is typically establishe early in the course of treatment, perhaps as early as the first 3 7 ays (73 80). We measure the outcomes after 1 week, 4 6 weeks, 12 weeks, 6 months, 1 year after the initiation of CPAP, an then monitor them yearly thereafter. Regarless of the specific time frame these outcomes nee to be measure longituinally because OSA shoul be viewe an treate as a chronic isease. Aressing CPAP intolerance early may improve CPAP aherence, whereas waiting for the requisite minimum 30 ays may allow entrenche problems to result in abanonment of, or suboptimal aherence to, CPAP. The current 31- to 90-ay requirement for ocumentation of CPAP aherence is arbitrary an not supporte by evience. The committee members prefer to ocument CPAP aherence earlier (i.e., 7 90 ) because there is evience that aressing CPAP intolerance early may improve long-term aherence (81 83). Moreover, CPAP aherence nees to be monitore long term (for as long as the patient is using CPAP). Finally, there are potentially ethical issues associate with the use of CPAP aherence monitoring systems as a requirement for Meicare payment. CPAP aherence has been shown to be relate to socioeconomic class, marital status, race, an psychiatric isease (84 86). These patients may have a ifficult time achieving the Meicare aherence patterns an thus certain segments of the population are potentially targets of governmentmanate reimbursement iscrimination (87, 88). FUTURE DIRECTIONS: RESEARCH STRATEGIES NEEDED TO ADDRESS CPAP TRACKING AND OUTCOMES There are many unanswere research questions involving CPAP tracking systems. First, oes tracking CPAP aherence improve clinical outcomes associate with OSA, an if so, which specific outcomes? It is important to perform stuies examining the valiity, reliability, an usefulness of CPAP tracking event etection (flow signals) an mask leak ata. It woul also be important to stuy which CPAP aherence system is most accurate. Stuies nee to etermine the clinically significant leak threshol an whether mask leak ecreases CPAP aherence. Finally, it is important to etermine the usefulness of measuring aitional signals, such as vibratory snoring, perioic breathing (Cheyne-Stokes pattern), RERA (respiratory effort relate arousal), flow limitation, an clear airway apnea (central sleep apnea). The valiity of these signals has yet to be etermine. Stuies nee to be performe that evaluate whether the use of these ata can improve CPAP aherence. Other potentially helpful signals woul inclue heart rate variability (ECG), oximetry (which woul allow the event etection algorithms to more closely reflect the stanar scoring criteria on polysomnograms for hypopneas), boy an neck position, actigraphy, quantification of snoring, bloo pressure, quantification of perioic limb movements, an a measure of sleep architecture. The secon critical issue is to evelop stanar efinitions of events across ifferent systems (i.e., apnea, hypopnea, flow limitation, AHI, an leak parameters). For example, CPAP ownloas typically report resiual AHI, which is confusing both to proviers an to patients. Because hypopnea scoring, when ahering to a wiely accepte stanar, requires either oxygen esaturation or arousal to be score (89), these reports may be misleaing because this AHI is only base on a reuction in airflow. We believe that the terminology for resiual AHI assessment shoul be stanarize, an suggest that it be reporte as resiual AHI Flow. Moreover, stuies nee to etermine a minimum threshol for clinically meaningful resiual AHI Flow base on outcome ata. Similarly, mask leak may impair CPAP effectiveness, but its measurement an reporting terminology are inconsistent. For example, typical CPAP ownloas may report average leak, large leak, an other information, but

6 618 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL o not typically inclue information about total leak minus expecte leak or artifact-free leak. It woul be helpful for leak to be reporte as total leak minus expecte leak in a stanarize manner across all manufacturers. Mouth leak shoul be quantifie in patients with a nasal mask as compare with leaking aroun the nasal mask. Not only shoul the terminology for CPAP aherence tracking measurements be stanarize but there also nees to be the evelopment an acceptance of common report formats among inustry partners. Data safety consierations nee to be incorporate into these systems. Finally, the meical/legal ramifications of CPAP aherence tracking systems nee to be etermine. CONCLUSIONS OSA is a chronic isease an nees to be manage accoringly (i.e., CPAP aherence shoul be monitore consistently over time). Increase CPAP usage has been shown to improve OSA outcomes. Thir-party payers are requiring ocumente use of therapy with CPAP tracking systems. CPAP aherence can be reliably etermine from CPAP tracking systems. However, the resiual events (apnea/hypopnea) an leak ata from CPAP tracking systems are not as easy to interpret an the efinitions of these parameters iffer among the manufacturers of CPAP aherence tracking systems. Nonetheless, ens of the spectrum (very high or low values for resiual events or mask leak) appear to be clinically meaningful. The health risks of patients with resiual OSA on the event etection algorithms are essentially unknown an nee to be stuie. CPAP tracking systems intuitively seem useful, although there are few stuies showing that CPAP aherence tracking systems improve CPAP aherence or OSA outcomes. Current clinical care systems are not optimally configure for this technology, yet most proviers are using CPAP tracking systems to monitor their patients with OSA. Use of CPAP aherence monitoring in real time for clinical ecision making base solely on intermeiate values for resiual AHI or mask leak is unclear, an therefore aitional stuies are inicate. At present, the ata are limite but the technology is young an evolving quickly. Because usage patterns for CPAP are often etermine in the first week (74, 90) it seems reasonable that ocumentation of CPAP aherence shoul be accepte between 7 an 90 ays, rather than the current 31- to 90-ay requirement, an CPAP aherence nees to be monitore long term (for as long as the patient is using CPAP). Nomenclature on the CPAP tracking reports nees to be stanarize an AHI Flow shoul be use to escribe resiual events. It is clear that stuies shoul be performe to examine the usefulness of the CPAP tracking systems an how these systems affect OSA outcomes. This official statement was prepare by an a hoc subcommittee of the Sleep an Respiratory Neurobiology Assembly. Members of the committee: RICHARD J. SCHWAB, M.D. (Chair) SAFWAN M. BADR, M.D. LAWRENCE J. EPSTEIN, M.D. PETER C. GAY, M.D. DAVID GOZAL, M.D. MALCOLM KOHLER, M.D. PATRICK LÉVY, M.D. ATUL MALHOTRA, M.D. BARBARA A. PHILLIPS, M.D., M.P.H. ILENE M. ROSEN, M.D., M.S.C.E. KINGMAN P. STROHL, M.D. PATRICK J. STROLLO, M.D. EDWARD M. WEAVER, M.D., M.P.H. TERRI E. WEAVER, Ph.D., R.N. Author Disclosures: R.J.S. reporte consulting for Apnex ($5,000 24,999) an ApniCure ($5,000 24,999). D.G. reporte consulting for Galleon ($5,000 24,999) an research support from ResMe. A.M. reporte consulting for Apnex ($10,000 49,999), ApniCure ($1,000 9,999), Galleon ($1,000 9,999), Philips Respironics ($10,001 49,999), Pfizer ($1,000 9,999), an SGS ($10,000 49,999). K.P.S. reporte serving as presient of ionsleep sleep meicine consultants an consulting for Inspire Meical Systems ($10,000 49,999); he serve on avisory committees for SleepMe ($5,001 10,000) an Sleep Solutions, Inc. ($5,001 10,000), an receive research support from Inspire Meical Systems ($10,000 49,999). P.J.S. reporte research support from ResMe ($10,000 49,999). T.E.W. reporte licensing agreements for FOSQ with Apnex, Cephalon, GlaxoSmithKline, Nova Norisk, Nova Som, an Philips Respironics; she receive royalties or license fees from Apnex ($5,000 24,999), Cephalon ($5,000 24,999), GlaxoSmithKline ($5,000 24,999), Nova Norisk ($ ,999), Nova Som ($5,000 24,999), an Philips Respironics ($5,000 24,999); she receive research support from Cephalon ($5,000 24,999), Nova Som ($5,000 24,999), an Philips Respironics ($5,000 24,999). S.M.B., L.J.E., P.C.G., M.K., P.L., B.A.P., I.M.R., an E.M.W. reporte they ha no relevant commercial interests. References 1. Young T, Palta M, Dempsey J, Skatru J, Weber S, Bar S. The occurrence of sleep-isorere breathing among mile-age aults. 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