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When is ambulatory monitoring for OSA indicated ?

When is ambulatory monitoring for OSA indicated ?. Robert P. Skomro MD, FRCPC, D.ABSM Associate Professor Division of Respiratory, Critical Care and Sleep Medicine University of Saskatchewan Saskatoon. AASM Classification.

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When is ambulatory monitoring for OSA indicated ?

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  1. When is ambulatory monitoring for OSA indicated ? Robert P. Skomro MD, FRCPC, D.ABSM Associate Professor Division of Respiratory, Critical Care and Sleep Medicine University of Saskatchewan Saskatoon

  2. AASM Classification • Level I: Standard polysomnography: Minimal requirements include recording of EEG, EOG, chin EMG, ECG, airflow, respiratory effort, and oxygen saturation. Body position must be documented or objectively measured. Trained personnel must be in constant attendance and able to intervene. Leg movement recording is desirable but optional. • Level II: Comprehensive portable polysomnography: Same as for level I, except heart rate instead of ECG is acceptable, and having trained personnel present and able to intervene is not required for all studies. • Level III: Modified portable sleep apnea testing: Minimum requirements include recording of ventilation (at least 2 channels of respiratory movement, or respiratory movement and airflow), ECG or heart rate, and oxygen saturation. Personnel are needed for preparation, but the ability to intervene is not required for all studies • Level IV: Continuous (single or dual) bioparameter recording: Only 1 or 2 physiologic variables need be recorded. The ability to intervene is not required.

  3. Obesity Trends* Among U.S. Adults1990, 1995, 2005 (*BMI 30, or about 30 lbs overweight for 5’4” person) 1995 1990 2005

  4. OSA PREVALENCE • Composite of Wisconsin, Pennsylvania, and Spain: • 1/ 5 adults with mild OSA, 1/ 15 at least moderate OSA • Young et al Am J Respir Crit Care Med 2002;165:1217-1239. • OSA AFFECTS 2-3% OF CHILDREN

  5. OSA incidence • Flemons et al estimate that 5.1% of adults will develop OSA over 8 years: • 0.6% per year • OSA incidence alone will require 600 studies per 100,000 population per year • What about repeat studies ?

  6. AASM/ACCP/ATS Review Results (Chest Oct.2003) Adapted from B.Boehlecke • Type 3 in-home unattended- 4 studies • Data loss 3-18% • Sensitivities 75-100% • Specificities 58-93% • False positives 2-31%,false negatives 0-45% • LR+ 1.8-9.0, LR- 0.13-0.43

  7. AASM/ACCP/ATS Review Results Adapted from B.Boehlecke • Type 3 in-laboratory - 9 studies • Data loss 3-9% • Define TP by PSG (AHI >15 when reported) • Best sensitivities 86-100% • Best specificities 88-100% • False positives 0-22%,false negatives 0-21% • LR+ 6.4-23.8, LR- 0.03-0.15

  8. AASM/ACCP/ATS Review Summary • Type 3 devices • “Type 3 monitors have utility to both reduce and increase the probability that a patient may have sleep apnea in the attended setting. The utility in the unattended setting is not as well-established”. (Page1573)

  9. Executive Summary(Am J RespirCrit Care Med) • Type 3 monitors for use in an unattended setting : • Not recommended to decrease or increase the probability that the patient has an AHI >15 • Not recommended for use to rule in and rule out OSA

  10. Position of CMS - USA Adapted from B.Boehlecke • “ Effectiveness of Portable Monitoring Devices of diagnosing Obstructive sleep apnea: update and systematic review “ - September 1,2004 • Centers for Medicare and Medicaid Services • Decision regarding CPAP coverage • www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=110 • “The polysomnography must be performed in a facility - based sleep study laboratory, and not in the home or in a mobile facility”.

  11. Update for Agency Health Care Research and QualitySeptember 2004 Adapted from B.Boehlecke • 12 studies reviewed in detail • Simultaneous in-lab comparison only • Type 3: 2 studies (fair and poor quality ratings) • Type 4: 5 studies (1 fair, 4 poor quality ratings) • Both in-lab and home comparisons • Type 3: 2 studies (good and fair/poor quality) • Type 4: 1 study (fair quality rating) • Only in-home studies compared to PSG • Type 4: 2 studies (fair and poor quality ratings)

  12. Reasons for lack of acceptance of level III home monitoring • Technical: • Lack of EEG monitoring • AHI cannot be established as sleep time is unknown • Failure rate of home monitoring • A large variety of home monitors – lack of standardization • Inability to perform CPAP titration • Scoring – are the automatic scoring systems reliable ?

  13. Reasons for lack of acceptance of level III home monitoring • Scientific: • Level of evidence • Lack of outcome studies • Poor external validity – studies not including patients with heart and lung problems, children, women, elderly

  14. Reasons for lack of acceptance of level III home monitoring • Other • Cost effectiveness of home monitoring questioned • Implementation depends on the availability and access to sleep labs in the area • Fees: who pays, how much ? • Quality control

  15. Mulgrew et al. Study results • Primary outcome: • AHI at 3 months • Secondary: • ESS, SAQLI, CPAP adherence

  16. AAMS 2007 guidelines • PM FOR THE DIAGNOSIS OF OSA SHOULD BE PERFORMED ONLY IN CONJUNCTION WITH A COMPREHENSIVE SLEEP EVALUATION. • CLINICAL SLEEP EVALUATIONS USING PM MUST BE SUPERVISED BY A PRACTITIONER WITH BOARD CERTIFICATION IN SLEEP MEDICINE OR AN INDIVIDUAL WHO FULFILLS THE ELIGIBILITY CRITERIA FOR THE SLEEP MEDICINE CERTIFICATION EXAMINATION. • IN THE ABSENCE OF A COMPREHENSIVE SLEEP EVALUATION, THERE IS NO INDICATION FOR THE USE OF PM.

  17. AAMS 2007 guidelines • PROVIDED THAT THE RECOMMENDATIONS OF 1.1 HAVE BEEN SATISFIED, PM MAY BE USED AS AN ALTERNATIVE TO POLYSOMNOGRAPHY (PSG) FOR THE DIAGNOSIS OF OSA IN PATIENTS WITH A HIGH PRETEST PROBABILITY OF MODERATE TO SEVERE OSA. • PM SHOULD NOT BE USED IN THE PATIENT GROUPS DESCRIBED IN 1.2.1, 1.2.2, AND 1.2.3 (THOSE WITH COMORBIDITIES, OTHER SLEEP DISORDERS, OR FOR SCREENING).

  18. AAMS 2007 guidelines • PM is not appropriate for general screening of asymptomatic populations. • PM MAY BE INDICATED FOR THE DIAGNOSIS OF OSA IN PATIENTS FOR WHOM IN-LABORATORY PSG IS NOT POSSIBLE BY VIRTUE OF IMMOBILITY, SAFETY, OR CRITICAL ILLNESS. • PM MAY BE INDICATED TO MONITOR THE RESPONSE TO NON-CPAP TREATMENTS FOR OBSTRUCTIVE SLEEP APNEA, INCLUDING ORAL APPLIANCES, UPPER AIRWAY SURGERY, AND WEIGHT LOSS

  19. AAMS 2007 guidelines • AT A MINIMUM, THE PMS MUST RECORD • AIRFLOW, • RESPIRATORY EFFORT • AND BLOOD OXYGENATION. • THE TYPE OF BIOSENSORS USED TO MONITOR THESE PARAMETERS FOR IN-LABORATORY PSG ARE RECOMMENDED FOR USE IN PMS.

  20. Canadian Thoracic Society OSA Guidelines 1. Level I (complete laboratory polysomnography) remains the accepted standard for evaluation of SDB and is the test of choice. 2. Level II (full ambulatory polysomnography) and level III portable monitoring (multichannel cardiorespiratory recording devices) play a useful role in improving access to the diagnosis of SDB.

  21. 3. Level II and III studies can be used to confirm the diagnosis of OSAHS in patients with a moderate to high pretest probability of this disorder, but are of more limited use in patients with co-morbid disease and for the diagnosis of other forms of SDB. 4.Studies using oximetry alone may have a role in the initial assessment of SDB, however, their significant limitations in distinguishing different types of SDB must be fully appreciated before using them to make diagnostic and therapeutic decisions

  22. Canadian Thoracic Society OSA Guidelines 5. The level of experience and training available to interpret the results of sleep monitoring is as important as the type of sleep monitoring. 6. All sleep monitoring should be conducted with an appropriate quality assurance program and interpreted by a physician trained in the diagnosis of SDB.

  23. CMMS CPAP Coverage Decision • Center for Medicare and Medicaid Services – USA • March 13, 2008

  24. CMMS 2008 • CPAP for adults is covered when diagnosed using a clinical evaluation and a positive: a. polysomnography (PSG) performed in a sleep laboratory; or b. unattended home sleep monitoring device of Type II; or c. unattended home sleep monitoring device of Type III; or d. unattended home sleep monitoring device of Type IV, measuring at least three channels

  25. CMMS decision • Coverage of CPAP is initially limited to a 12 week period for beneficiaries diagnosed with OSA as subsequently described. • CPAP is subsequently covered for those beneficiaries diagnosed with OSA whose OSA improved as a result of CPAP during this 12 week period

  26. CMMS 2008 • AHI or RDI greater than or equal to 15 events per hour, or • AHI or RDI greater than or equal to 5 and less than or equal to 14 events per hour with documented • symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or • documented hypertension, ischemic heart disease, or history of stroke.

  27. Berry et al. • Randomised to home diagnosis and therapy using Peripheral Arterial Tonometry device and auto-CPAP or in-lab PSG • Primary outcome – CPAP adherence at 6 weeks • Secondary outcomes: ESS, FOSQ • No difference in outcomes

  28. Antic NA et al. • 1427 screened • 193 patients with moderate-to-severe pre- test probability of OSA based on oximetry • Randomised to • Nurse-driven care: auto CPAP + fixed CPAP • In-lab PSG X 2 supervised by sleep medicine physician • Main outcome: ESS at 3 months

  29. Antic NA et al. • At 3 months there were similar decreases in ESS • 4.02 vs. 4.15; difference, -0.13; 95% confidence interval: -1.52, 1.25 • No difference in CPAP adherence • Nurse-driven care less expensive.

  30. Patients’ characteristics in RCT of Level III

  31. Patient selection for Level III • Evidence from 4 RCTs: • Moderate – high pretest probability of OSA • No comorbidities • Predominantly male • Very selected group: 3.7-37%

  32. Evolution of diagnosis and treatment of OSA 1981 2011 Diagnostic PSG + manual CPAP titration = 2 lab nights Split-night PSG = 1 night Diagnostic PSG + auto-CPAP in the lab = 2 nights ( but less technician time) Diagnostic PSG + auto-CPAP at home = 1 night Diagnostic HM ( in the lab) + auto-CPAP (at home) = 1 night Diagnostic HM (at home ) + auto-CPAP (at home)

  33. Parameters for In-home Unattended Limited Channel Devices for the Diagnosis of OSA (Westbrook, J Clin Sleep Med. 2007 April 15; 3(3): 318–320).– survey of 175 AASM members • SpO2 • Ability to edit automated scoring or to fully manually score recordings • Airflow -Nasal Pressure • Detection and marking of periods of poor signal quality • Full disclosure recording • Signals needed to differentiate obstructive/central events • Pulse Rate • User defined event criteria • Head/Body Position • Respiratory Effort - Qualitative

  34. Quality of the Validation of the In-home Unattended Limited Channel • Less than 10% failure rate • PSG criteria/parameters used to assess accuracy • In-home to PSG sensitivity > 0.9, specificity > 0.8 • Clinical study - In-home vs. PSG: N> 100 • Clinical study - portable device concurrent with PSG; N > 40

  35. CTS 2011 Update • Evidence from 2 Systematic Reviews and 3 RCTs: • Level II, III, IV devices can be used to confirm the diagnosis of OSA in patients with moderate to high pretest probability of this disorder when integrated into a package of care that includes the appropriate level of physician and allied health professional expertise and the backup availability of PSG ( 1B)

  36. CTS 2011 • These devices should be used only with caution in patients with co-morbid diseases and for the diagnosis of other forms of SDB (2C) • The limitations of overnight oximetry in distinguishing between different types of SDB must be fully appreciated before they are used to make diagnostic and therapeutic decisions (1B)

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