Robert P. Skomro MD, FRCPC, D.ABSMRobert P. Skomro MD, FRCPC, D.ABSMAssociate Professor Associate Professor

Division of Respiratory, Critical Care and Sleep Division of Respiratory, Critical Care and Sleep MedicineMedicine

University of SaskatchewanUniversity of SaskatchewanSaskatoonSaskatoon

Level I: Standard polysomnography: Minimal requirements include Level I: Standard polysomnography: Minimal requirements include recording of EEG, EOG, chin EMG, ECG, airflow, respiratory effort, and recording of EEG, EOG, chin EMG, ECG, airflow, respiratory effort, and oxygen saturation. Body position must be documented or objectively oxygen saturation. Body position must be documented or objectively measured. Trained personnel must be in constant attendance and able measured. Trained personnel must be in constant attendance and able to intervene. Leg movement recording is desirable but optional. to intervene. Leg movement recording is desirable but optional.

Level II: Comprehensive portable polysomnography: Same as for level Level II: Comprehensive portable polysomnography: Same as for level I, except heart rate instead of ECG is acceptable, and having trained I, except heart rate instead of ECG is acceptable, and having trained personnel present and able to intervene is not required for all studies. personnel present and able to intervene is not required for all studies.

Level III: Modified portable sleep apnea testing: Minimum Level III: Modified portable sleep apnea testing: Minimum requirements include recording of ventilation (at least 2 channels of requirements include recording of ventilation (at least 2 channels of respiratory movement, or respiratory movement and airflow), ECG or respiratory movement, or respiratory movement and airflow), ECG or heart rate, and oxygen saturation. Personnel are needed for heart rate, and oxygen saturation. Personnel are needed for preparation, but the ability to intervene is not required for all studies preparation, but the ability to intervene is not required for all studies

Level IV: Continuous (single or dual) bioparameter recording: Only 1 or Level IV: Continuous (single or dual) bioparameter recording: Only 1 or 2 physiologic variables need be recorded. The ability to intervene is 2 physiologic variables need be recorded. The ability to intervene is not required.not required.

1995

Obesity Trends* Among U.S. Adults 1990, 1995, 2005

(*BMI 30, or about 30 lbs overweight for 5’4” person)

2005

1990

Composite of Wisconsin, Composite of Wisconsin, Pennsylvania, and Spain:Pennsylvania, and Spain:

1/ 5 adults with mild OSA, 1/ 15 at least 1/ 5 adults with mild OSA, 1/ 15 at least moderate OSAmoderate OSA

Young et al Am J Respir Crit Care Young et al Am J Respir Crit Care Med 2002;165:1217-1239Med 2002;165:1217-1239. .

OSA AFFECTS 2-3% OF CHILDRENOSA AFFECTS 2-3% OF CHILDREN

Flemons et al estimate that 5.1% of adults will Flemons et al estimate that 5.1% of adults will develop OSA over 8 years:develop OSA over 8 years:

0.6% per year0.6% per year

OSA incidence alone will require 600 studies per OSA incidence alone will require 600 studies per 100,000 population per year100,000 population per year

What about repeat studies ?What about repeat studies ?

Type 3 in-home unattended- 4 Type 3 in-home unattended- 4 studies studies Data loss 3-18%Data loss 3-18% Sensitivities 75-100%Sensitivities 75-100% Specificities 58-93% Specificities 58-93% False positives 2-31%,false negatives False positives 2-31%,false negatives

0-45%0-45%

LR+ 1.8-9.0, LR- 0.13-0.43LR+ 1.8-9.0, LR- 0.13-0.43Adapted from B.BoehleckeAdapted from B.Boehlecke

Type 3 in-laboratory - 9 studies Type 3 in-laboratory - 9 studies Data loss 3-9%Data loss 3-9% Define TP by PSG (AHI >15 when Define TP by PSG (AHI >15 when

reported) reported) Best sensitivities 86-100%Best sensitivities 86-100% Best specificities 88-100% Best specificities 88-100% False positives 0-22%,false negatives 0-False positives 0-22%,false negatives 0-

21%21%

LR+ 6.4-23.8, LR- 0.03-0.15LR+ 6.4-23.8, LR- 0.03-0.15Adapted from B.BoehleckeAdapted from B.Boehlecke

Type 3 devices Type 3 devices ““Type 3 monitors have utility to both Type 3 monitors have utility to both

reduce and increase the probability reduce and increase the probability that a patient may have sleep apnea that a patient may have sleep apnea in the in the attendedattended setting. The utility in setting. The utility in the the unattendedunattended setting is not as setting is not as well-established”. (Page1573)well-established”. (Page1573)

Type 3Type 3 monitors for use in an monitors for use in an unattendedunattended setting : setting :

Not recommendedNot recommended to decrease or to decrease or

increase the probability that the increase the probability that the patient has an AHI >15patient has an AHI >15

Not recommended for use to rule in Not recommended for use to rule in and rule out OSAand rule out OSA

“ “ Effectiveness of Portable Monitoring Effectiveness of Portable Monitoring Devices of diagnosing Obstructive sleep Devices of diagnosing Obstructive sleep apnea: update and systematic review “ - apnea: update and systematic review “ - September 1,2004September 1,2004

Centers for Medicare and Medicaid ServicesCenters for Medicare and Medicaid Services Decision regarding CPAP coverage Decision regarding CPAP coverage

www.cms.hhs.gov/mcdwww.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=110/viewdecisionmemo.asp?id=110 ““The polysomnography must be performed in a facility The polysomnography must be performed in a facility

- based sleep study laboratory, and not in the home or - based sleep study laboratory, and not in the home or in a mobile facility”.in a mobile facility”.

Adapted from B.BoehleckeAdapted from B.Boehlecke

12 studies reviewed in detail12 studies reviewed in detail Simultaneous in-lab comparison onlySimultaneous in-lab comparison only

Type 3: 2 studies (fair and poor quality ratings)Type 3: 2 studies (fair and poor quality ratings) Type 4: 5 studies (1 fair, 4 poor quality ratings)Type 4: 5 studies (1 fair, 4 poor quality ratings)

Both in-lab and home comparisonsBoth in-lab and home comparisons Type 3: 2 studies (good and fair/poor quality)Type 3: 2 studies (good and fair/poor quality) Type 4: 1 study (fair quality rating)Type 4: 1 study (fair quality rating)

Only in-home studies compared to PSGOnly in-home studies compared to PSG Type 4: 2 studies (fair and poor quality ratings) Type 4: 2 studies (fair and poor quality ratings)

Adapted from B.BoehleckeAdapted from B.Boehlecke

Technical:Technical: Lack of EEG monitoringLack of EEG monitoring

AHI cannot be established as sleep time is unknownAHI cannot be established as sleep time is unknown Failure rate of home monitoringFailure rate of home monitoring A large variety of home monitors – lack of A large variety of home monitors – lack of

standardizationstandardization Inability to perform CPAP titrationInability to perform CPAP titration Scoring – are the automatic scoring systems Scoring – are the automatic scoring systems

reliable ?reliable ?

Scientific:Scientific: Level of evidence Level of evidence Lack of outcome studiesLack of outcome studies Poor external validity – studies not Poor external validity – studies not

including patients with heart and including patients with heart and lung problems, children, women, lung problems, children, women, elderlyelderly

OtherOther Cost effectiveness of home monitoring Cost effectiveness of home monitoring

questionedquestioned Implementation depends on the Implementation depends on the

availability and access to sleep labs in availability and access to sleep labs in the areathe area

Fees: who pays, how much ?Fees: who pays, how much ? Quality controlQuality control

Primary outcome:Primary outcome: AHI at 3 monthsAHI at 3 months

Secondary:Secondary: ESS, SAQLI, CPAP adherenceESS, SAQLI, CPAP adherence

PM FOR THE DIAGNOSIS OF OSA SHOULD BE PERFORMED PM FOR THE DIAGNOSIS OF OSA SHOULD BE PERFORMED ONLY IN CONJUNCTION WITH A COMPREHENSIVE SLEEP ONLY IN CONJUNCTION WITH A COMPREHENSIVE SLEEP EVALUATION. EVALUATION.

CLINICAL SLEEP EVALUATIONS USING PM MUST BE CLINICAL SLEEP EVALUATIONS USING PM MUST BE SUPERVISED BY A PRACTITIONER WITH BOARD SUPERVISED BY A PRACTITIONER WITH BOARD CERTIFICATION IN SLEEP MEDICINE OR AN INDIVIDUAL CERTIFICATION IN SLEEP MEDICINE OR AN INDIVIDUAL WHO FULFILLS THE ELIGIBILITY CRITERIA FOR THE SLEEP WHO FULFILLS THE ELIGIBILITY CRITERIA FOR THE SLEEP MEDICINE CERTIFICATION EXAMINATION. MEDICINE CERTIFICATION EXAMINATION.

IN THE ABSENCE OF A COMPREHENSIVE SLEEP IN THE ABSENCE OF A COMPREHENSIVE SLEEP EVALUATION, THERE IS NO INDICATION FOR THE USE OF EVALUATION, THERE IS NO INDICATION FOR THE USE OF PM.PM.

PROVIDED THAT THE RECOMMENDATIONS OF PROVIDED THAT THE RECOMMENDATIONS OF 1.1 HAVE BEEN SATISFIED, PM MAY BE USED AS 1.1 HAVE BEEN SATISFIED, PM MAY BE USED AS AN ALTERNATIVE TO POLYSOMNOGRAPHY (PSG) AN ALTERNATIVE TO POLYSOMNOGRAPHY (PSG) FOR THE DIAGNOSIS OF OSA IN PATIENTS WITH FOR THE DIAGNOSIS OF OSA IN PATIENTS WITH A HIGH PRETEST PROBABILITY OF MODERATE A HIGH PRETEST PROBABILITY OF MODERATE TO SEVERE OSA. TO SEVERE OSA.

PM SHOULD NOT BE USED IN THE PATIENT PM SHOULD NOT BE USED IN THE PATIENT GROUPS DESCRIBED IN 1.2.1, 1.2.2, AND 1.2.3 GROUPS DESCRIBED IN 1.2.1, 1.2.2, AND 1.2.3 (THOSE WITH COMORBIDITIES, OTHER SLEEP (THOSE WITH COMORBIDITIES, OTHER SLEEP DISORDERS, OR FOR SCREENING).DISORDERS, OR FOR SCREENING).

PM is not appropriate for general screening of asymptomatic PM is not appropriate for general screening of asymptomatic populations.populations.

PM MAY BE INDICATED FOR THE DIAGNOSIS OF OSA IN PM MAY BE INDICATED FOR THE DIAGNOSIS OF OSA IN PATIENTSPATIENTSFOR WHOM IN-LABORATORY PSG IS NOT POSSIBLE BY VIRTUE FOR WHOM IN-LABORATORY PSG IS NOT POSSIBLE BY VIRTUE OF IMMOBILITY, SAFETY, OR CRITICAL ILLNESS.OF IMMOBILITY, SAFETY, OR CRITICAL ILLNESS.

PM MAY BE INDICATED TO MONITOR THE RESPONSE TO NON-PM MAY BE INDICATED TO MONITOR THE RESPONSE TO NON-CPAPCPAPTREATMENTS FOR OBSTRUCTIVE SLEEP APNEA, INCLUDING TREATMENTS FOR OBSTRUCTIVE SLEEP APNEA, INCLUDING ORAL APPLIANCES, UPPER AIRWAY SURGERY, AND WEIGHT ORAL APPLIANCES, UPPER AIRWAY SURGERY, AND WEIGHT LOSSLOSS

AT A MINIMUM, THE PMS MUST RECORD AT A MINIMUM, THE PMS MUST RECORD AIRFLOWAIRFLOW, ,

RESPIRATORY EFFORT RESPIRATORY EFFORT AND BLOOD OXYGENATION. AND BLOOD OXYGENATION.

THE TYPE OF BIOSENSORS USED TO MONITOR THE TYPE OF BIOSENSORS USED TO MONITOR THESE PARAMETERS FOR IN-LABORATORY PSG THESE PARAMETERS FOR IN-LABORATORY PSG ARE RECOMMENDED FOR USE IN PMS.ARE RECOMMENDED FOR USE IN PMS.

1. Level I (complete laboratory polysomnography) 1. Level I (complete laboratory polysomnography) remains the accepted standard for evaluation of SDB remains the accepted standard for evaluation of SDB and is the test of choice.and is the test of choice.

2. Level II (full ambulatory polysomnography) and level III 2. Level II (full ambulatory polysomnography) and level III portable monitoring (multichannel cardiorespiratory portable monitoring (multichannel cardiorespiratory recording devices) play a useful role in improving recording devices) play a useful role in improving access to the diagnosis of SDB.access to the diagnosis of SDB.

3. 3. Level II and III studies can be used to confirm theLevel II and III studies can be used to confirm the diagnosis of OSAHS in patients with a moderate to high pretest diagnosis of OSAHS in patients with a moderate to high pretest

probability of this disorder, but are of more limited use in patients 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.with co-morbid disease and for the diagnosis of other forms of SDB.

4.Studies using oximetry alone may have a role in the 4.Studies using oximetry alone may have a role in the initial assessment of SDB, however, their significant initial assessment of SDB, however, their significant limitations in distinguishing different types of SDB must limitations in distinguishing different types of SDB must be fully appreciated before using them to make be fully appreciated before using them to make diagnostic and therapeutic decisionsdiagnostic and therapeutic decisions

55. . The level of experience and training available to The level of experience and training available to interpret the results of sleep monitoring is as important interpret the results of sleep monitoring is as important as the type of sleep monitoring.as the type of sleep monitoring.

6. All sleep monitoring should be conducted with an 6. All sleep monitoring should be conducted with an appropriate quality assurance program and interpreted appropriate quality assurance program and interpreted by a physician trained in the diagnosis of SDB.by a physician trained in the diagnosis of SDB.

Center for Medicare and Center for Medicare and Medicaid Services – USAMedicaid Services – USA March 13, 2008March 13, 2008

CPAP for adults is covered when diagnosed CPAP for adults is covered when diagnosed using a clinical evaluation and a positive:using a clinical evaluation and a positive:

a. polysomnography (PSG) performed in a sleep a. polysomnography (PSG) performed in a sleep laboratory; orlaboratory; or

b. unattended home sleep monitoring device of b. unattended home sleep monitoring device of Type II; orType II; or

c. unattended home sleep monitoring device of c. unattended home sleep monitoring device of Type III; orType III; or

d. unattended home sleep monitoring device of d. unattended home sleep monitoring device of Type IV, measuring at least three channelsType IV, measuring at least three channels

Coverage of CPAP is initially limited to a 12 week Coverage of CPAP is initially limited to a 12 week period for beneficiaries diagnosed with OSA as period for beneficiaries diagnosed with OSA as subsequently described. subsequently described.

CPAP is subsequently covered for those CPAP is subsequently covered for those beneficiaries diagnosed with OSA whose OSA beneficiaries diagnosed with OSA whose OSA improved as a result of CPAP during this 12 week improved as a result of CPAP during this 12 week periodperiod

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

AHI or RDI greater than or equal to 5 and AHI or RDI greater than or equal to 5 and less than or equal to 14 events per hour less than or equal to 14 events per hour with documentedwith documented symptoms of excessive daytime sleepiness, symptoms of excessive daytime sleepiness,

impaired cognition, mood disorders or insomnia, orimpaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, documented hypertension, ischemic heart disease,

or history of stroke.or history of stroke.

• Randomised to home diagnosis Randomised to home diagnosis and therapy using Peripheral and therapy using Peripheral Arterial Tonometry device and Arterial Tonometry device and auto-CPAP or in-lab PSGauto-CPAP or in-lab PSG

• Primary outcome – CPAP Primary outcome – CPAP adherence at 6 weeksadherence at 6 weeks

• Secondary outcomes: ESS, FOSQSecondary outcomes: ESS, FOSQ• No difference in outcomesNo difference in outcomes

1427 screened 1427 screened 193 patients with moderate-to-severe pre- 193 patients with moderate-to-severe pre-

test probability of OSA based on oximetry test probability of OSA based on oximetry Randomised to Randomised to

Nurse-driven care: auto CPAP + fixed CPAPNurse-driven care: auto CPAP + fixed CPAP In-lab PSG X 2 supervised by sleep medicine In-lab PSG X 2 supervised by sleep medicine

physicianphysician

Main outcome: ESS at 3 monthsMain outcome: ESS at 3 months

At 3 months there were similar At 3 months there were similar decreases in ESSdecreases in ESS 4.02 vs. 4.15; difference, -0.13; 95% 4.02 vs. 4.15; difference, -0.13; 95%

confidence interval: -1.52, 1.25 confidence interval: -1.52, 1.25

No difference in CPAP adherenceNo difference in CPAP adherence

Nurse-driven care less expensive.Nurse-driven care less expensive.

Patients’ characteristics in RCT of Patients’ characteristics in RCT of

Level IIILevel IIIStudy N enrolled/ N screened

Device used Inclusion criteria

Mulgrew2007

79/2135Males 75-79%

Oximetry ESS > 10, SACS > 15, ODI > 15

Berry 2008

106/ not specifiedMales 90%

Watch Pad 100 ESS > 12, and 2 of: snoring, apnea, HTN.

Antic2009

195/1427Males – 72-76%

Oximetry, ESS > 8, age 18-75, ODI > 27

Skomro 2010

102/270Males 66%

Embletta Two of :ESS > 10, apnea and snoring AND age > 18,

• Evidence from 4 RCTs:Evidence from 4 RCTs: Moderate – high pretest probability Moderate – high pretest probability

of OSAof OSA No comorbiditiesNo comorbidities Predominantly malePredominantly male Very selected group:Very selected group:

3.7-37%3.7-37%

Diagnostic PSG + manual CPAP titration = Diagnostic PSG + manual CPAP titration = 2 lab 2 lab nightsnights

Split-night PSG = 1 night Split-night PSG = 1 night Diagnostic PSG + auto-CPAP in the lab = 2 Diagnostic PSG + auto-CPAP in the lab = 2

nights ( but less technician time)nights ( but less technician time) Diagnostic PSG + auto-CPAP at home = 1 nightDiagnostic PSG + auto-CPAP at home = 1 night Diagnostic HM ( in the lab) + auto-CPAP (at Diagnostic HM ( in the lab) + auto-CPAP (at

home) = 1 nighthome) = 1 night Diagnostic HM (Diagnostic HM (at homeat home ) + auto-CPAP ( ) + auto-CPAP (at at

homehome))

1981

2011

SpO2SpO2 Ability to edit automated scoring or to fully manually score Ability to edit automated scoring or to fully manually score

recordingsrecordings Airflow -Nasal PressureAirflow -Nasal Pressure Detection and marking of periods of poor signal qualityDetection and marking of periods of poor signal quality Full disclosure recordingFull disclosure recording Signals needed to differentiate obstructive/central eventsSignals needed to differentiate obstructive/central events Pulse RatePulse Rate User defined event criteriaUser defined event criteria Head/Body PositionHead/Body Position Respiratory Effort - QualitativeRespiratory Effort - Qualitative

Less than 10% failure rateLess than 10% failure rate PSG criteria/parameters used to assess PSG criteria/parameters used to assess

accuracyaccuracy In-home to PSG sensitivity > 0.9, In-home to PSG sensitivity > 0.9,

specificity > 0.8specificity > 0.8 Clinical study - In-home vs. PSG: N> 100 Clinical study - In-home vs. PSG: N> 100 Clinical study - portable device concurrent Clinical study - portable device concurrent

with PSG; N > 40with PSG; N > 40

• Evidence from 2 Systematic Reviews and Evidence from 2 Systematic Reviews and 3 RCTs:3 RCTs: Level II, III, IV devices can be used to confirm Level II, III, IV devices can be used to confirm

the diagnosis of OSA in patients with the diagnosis of OSA in patients with moderate to high pretest probability of this moderate to high pretest probability of this disorder when integrated into a package of disorder when integrated into a package of care that includes the appropriate level of care that includes the appropriate level of physician and allied health professional physician and allied health professional expertise and the backup availability of PSG ( expertise and the backup availability of PSG ( 1B)1B)

• These devices should be used only with caution in patients These devices should be used only with caution in patients with co-morbid diseases and for the diagnosis of other forms of with co-morbid diseases and for the diagnosis of other forms of SDB (2C)SDB (2C)

• The limitations of overnight oximetry in distinguishing between The limitations of overnight oximetry in distinguishing between different types of SDB must be fully appreciated before they different types of SDB must be fully appreciated before they are used to make diagnostic and therapeutic decisions (1B)are used to make diagnostic and therapeutic decisions (1B)

Data loss – in our center <10%.Data loss – in our center <10%. Automated scoring not accurateAutomated scoring not accurate Indeterminate study results (esp. if separate Indeterminate study results (esp. if separate

thresholds for + and – used to increase thresholds for + and – used to increase sensitivity/specificity)sensitivity/specificity)

Can’t perform “split night” studiesCan’t perform “split night” studies Can’t determine sleep architecture/quality, freq or Can’t determine sleep architecture/quality, freq or

types of arousals, other abnormalitiestypes of arousals, other abnormalities Misdiagnoses esp. if co-morbid conditions presentMisdiagnoses esp. if co-morbid conditions present

Reasonable PPV for moderate and severe OSAReasonable PPV for moderate and severe OSA Poor NPVPoor NPV Require a repeat in 5-15 %Require a repeat in 5-15 % Should not be used without proper assessment of Should not be used without proper assessment of

pre-test probability of OSApre-test probability of OSA i.e by qualified sleep medicine consultanti.e by qualified sleep medicine consultant

Should not be applied to patients with comorbiditesShould not be applied to patients with comorbidites Should be scored by a qualified technician and Should be scored by a qualified technician and

interpreted by a qualified sleep medicine physicianinterpreted by a qualified sleep medicine physician

• Level III devices are already Level III devices are already widely used in diagnosis of OSA in widely used in diagnosis of OSA in parts of Canada, USA, Europeparts of Canada, USA, Europe

• Current guidelines from AASM, Current guidelines from AASM, CTS define their diagnostic role CTS define their diagnostic role and limitationsand limitations

• Dissemination and Dissemination and implementationimplementation

InclusionInclusion criteriacriteria - 18 – 65 years of age- 18 – 65 years of age - Epworth Sleepiness Scale - Epworth Sleepiness Scale >> 1010 - Berlin score- Berlin score - BMI > 30- BMI > 30 - Symptoms of snoring and apnea- Symptoms of snoring and apnea - Ability to use home testing- Ability to use home testing

Exclusion CriteriaExclusion Criteria - Cardiac disease/CHF- Cardiac disease/CHF - Respiratory disease, obesity hypoventilation- Respiratory disease, obesity hypoventilation - Sleeping disorder- Sleeping disorder - Currently on CPAP, BiPAP or- Currently on CPAP, BiPAP or supplemental O2supplemental O2 - Safety sensitive occupation- Safety sensitive occupation - Upper airway or palatal surgery- Upper airway or palatal surgery

Physician Referral to Sleep Disorders CenterPhysician Referral to Sleep Disorders Center

Sleep Physician AssessmentSleep Physician Assessment

High Likelihood OSA High Likelihood OSA Low Likelihood OSALow Likelihood OSA

Embletta In-Home MonitoringEmbletta In-Home Monitoring Sleep Lab PSG TestingSleep Lab PSG Testing

Positive Positive Negative Negative

Auto CPAP TrialAuto CPAP Trial

Positive CPAP ResponsivePositive CPAP Responsive CPAP UnresponsiveCPAP Unresponsive

Clinic Follow-upClinic Follow-up

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

In a subset of patients with OSA, in-home testing In a subset of patients with OSA, in-home testing is feasibleis feasible

Up to 38% may qualify for home testingUp to 38% may qualify for home testing Preliminary data shows that of those who qualify Preliminary data shows that of those who qualify

69% can be diagnosed and treated at home69% can be diagnosed and treated at home Patients prefer home testing to PSG.Patients prefer home testing to PSG.

Univ. of Saskatchewan

Thank you