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 1

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. 2

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

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 4

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 ? 5

AASM/ACCP/ATS Review Results (Chest Oct.2003) 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 Adapted from B.Boehlecke 6

AASM/ACCP/ATS Review Results 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 Adapted from B.Boehlecke 7

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) 8

Executive Summary (Am J Respir Crit 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 9

Position of CMS - USA “ 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”. Adapted from B.Boehlecke 10

Update for Agency Health Care Research and Quality September 2004 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) Adapted from B.Boehlecke 11

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 ? 12

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 13

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 14

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Mulgrew et al. Study results Primary outcome: AHI at 3 months Secondary: ESS, SAQLI, CPAP adherence 17

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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. 20

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). 21

PM MAY BE INDICATED FOR THE DIAGNOSIS OF OSA IN PATIENTS 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 22

AT A MINIMUM, THE PMS MUST RECORD 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. 23

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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. 25

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 26

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. 27

CMMS CPAP Coverage Decision Center for Medicare and Medicaid Services – USA March 13, 2008 28

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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 30

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 31

AHI or RDI greater than or equal to 15 events per hour, or 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. 32

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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 34

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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 36

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. 37

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Patients’ characteristics in RCT of Level III Study N enrolled/ N screened Device used Inclusion criteria Mulgrew 2007 79/2135 Males 75-79% Oximetry ESS > 10, SACS > 15, ODI > 15 Berry 2008 106/ not specified Males 90% Watch Pad 100 ESS > 12, and 2 of: snoring, apnea, HTN. Antic 2009 195/1427 Males – 72-76% Oximetry, ESS > 8, age 18-75, ODI > 27 Skomro 2010 102/270 Males 66% Embletta Two of :ESS > 10, apnea and snoring AND age > 18, 43

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% 44

Evolution of diagnosis and treatment of OSA 1981 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) 2011 45

Airflow -Nasal Pressure 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 46

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 47

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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) 49

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) 50

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Home Study Potential Disadvantages Data loss – in our center <10%. Automated scoring not accurate Indeterminate study results (esp. if separate thresholds for + and – used to increase sensitivity/specificity) Can’t perform “split night” studies Can’t determine sleep architecture/quality, freq or types of arousals, other abnormalities Misdiagnoses esp. if co-morbid conditions present 52

Level III monitors - summary Reasonable PPV for moderate and severe OSA Poor NPV Require a repeat in 5-15 % Should not be used without proper assessment of pre-test probability of OSA i.e by qualified sleep medicine consultant Should not be applied to patients with comorbidites Should be scored by a qualified technician and interpreted by a qualified sleep medicine physician 53

Future of diagnosis of OSA ? Level III devices are already widely used in diagnosis of OSA in parts of Canada, USA, Europe Current guidelines from AASM, CTS define their diagnostic role and limitations Dissemination and implementation 54

The Sleep Well Program: In-Home Testing and Treatment for Obstructive Sleep Apnea 55

- 18 – 65 years of age Inclusion criteria Patient Selection Inclusion criteria - 18 – 65 years of age - Epworth Sleepiness Scale > 10 - Berlin score - BMI > 30 - Symptoms of snoring and apnea - Ability to use home testing 56

Exclusion Criteria - Cardiac disease/CHF Patient Selection Exclusion Criteria - Cardiac disease/CHF - Respiratory disease, obesity hypoventilation - Sleeping disorder - Currently on CPAP, BiPAP or supplemental O2 - Safety sensitive occupation - Upper airway or palatal surgery 57

Sleep Well Flow Process Physician Referral to Sleep Disorders Center Sleep Physician Assessment High Likelihood OSA Low Likelihood OSA Embletta In-Home Monitoring Sleep Lab PSG Testing Positive Negative Auto CPAP Trial Positive CPAP Responsive CPAP Unresponsive Clinic Follow-up 58

Data available on 317 patients – one month f/u. Outcomes Data available on 317 patients – one month f/u. - Successful: RDI>5 + autoCPAP trial + compliance > 4 hours after 4 weeks 218 (69%) - Unsuccessful: 58 (18%) - Declined/Refused/No Show 41 (13%) 59

In a subset of patients with OSA, in-home testing is feasible Summary In a subset of patients with OSA, in-home testing is feasible Up to 38% may qualify for home testing Preliminary data shows that of those who qualify 69% can be diagnosed and treated at home Patients prefer home testing to PSG. 60

Univ. of Saskatchewan Thank you 61