Update on Home Sleep Studies Is there a Home for Portable Monitoring? Samuel T. Kuna, MD Center for Sleep and Respiratory Neurobiology University of Pennsylvania and Pulmonary, Critical Care & Sleep Section Philadelphia VAMC
Sleep Disorder Center
Lack of Evidence Validating In-Lab PSGs Scoring by pattern recognition of qualitative signals Lack of association of primary PSG outcome (AHI) with clinical symptoms and outcomes Disease severity classification based on AHI formulated by concensus Lack of uniform scoring criteria for hypopneas
Types of Sleep Studies Type 1 Attended in-lab polysomnography Type 2 Comprehensive portable polysomnography Minimum of 7 channels including EEG, EOG, chin EMG, ECG/HR, airflow, respiratory effort and O2 saturation Type 3 Modified portable sleep apnea testing Minimum of 4 channels including ECG/HR, O2 saturation and at least 2 channels of respiratory movement or respiratory movement and airflow, Type 4 Continuous single or dual bioparameters For example, airflow and/or O2 saturation PAT is classified as a Type 4 monitor ASDA Standards of Practice. Sleep 17:372-7, 1994
Embletta a Type 3 PM Signals Recorded Nasal pressure Snoring Rib cage and abdominal movement Pulse oximetry Body position
Apnea Risk Evaluation System (ARES) a Type 3 PM Signals Recorded O2 saturation/heart Rate Nasal Pressure Respiratory effort Snoring level (microphone) Head position/movement (accelerometers) Westbrook PR. Chest 2005; 128:2166-75
Hispanic Community Health Study A target population of 16,000 persons of Hispanic/ Latino origin, specifically Cuban, Puerto Rican, Mexican, and Central/South American, aged 18-74 years will undergo an extensive clinic exam and assessments to determine baseline risk factors. Annual follow-up interviews will be conducted for 2-4 years to determine health outcomes of interest.
WatchPAT a Type 4 PM Signals Recorded Peripheral arterial tone Heart rate Pulse oximetry Actigraphy
Wizard a Type 4 monitor
Signals Recorded by Most Type 3 PMs Signal EEG (2) EOG (2) Chin EMG ECG Nasal Pressure Snoring Respiratory Belts Pulse Oximetry Body Position Leg Movements PSG PM
AHI on Facility-based PSG vs RDI on Home Type 3 Monitor Ayappa et al. Sleep 27:1171-9, 2004
Night-to-Night Variability of AHI on In-lab PSG (Same equipment and environment, different nights) 100 AHI AHI Night 2 (events/hr) 80 60 40 20 0 FN TN TP 0 20 40 60 80 100 AHI Night 1 (events/hr) FN AHI Night 1 (events/hr) Bliwise et al. Chest 100: 973-6, 1991 Aber et al. Chest 96: 747-51, 1989 Chediak et al. Sleep 19: 589-92, 1996
Difficulty in Validating Home Unattended Type 3 PM Studies to In-Lab PSGs Significant differences among portable monitors within the same class Type 3 and Type 4 monitors underestimate the AHI (recording time vs sleep time) Night-to-night variability of AHI on in-lab PSG Most validation studies have flawed study designs, are underpowered, and used monitors with older technology
CMS National Coverage Decision (NCD) for Sleep Testing for OSA (CAG-00405N; March 3, 2009) The following tests will be covered when used to diagnose OSA in beneficiaries who have clinical signs and symptoms indicative of OSA: Attended, in-lab polysomnography Type I Portable monitor testing performed unattended in or out of a sleep lab facility or attended in a sleep lab facility Type 2 or a Type 3 sleep testing device Type 4 sleep testing device measuring 3 or more channels, one of which is airflow www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=227
CMS NCD for CPAP Therapy for OSA (CAG-00093R2; March 13, 2008) CPAP for adults is covered when OSA is diagnosed using a clinical evaluation and positive results on an attended Type I, and unattended Type 2, 3 or 4 tests, the latter measuring at least 3 channels. A positive test requires an apnea hypopnea index (AHI) or respiratory disturbance index (RDI) of: Greater than or equal to 15 events/hr, or Greater than or equal to 5 events/hr with clinical signs/symptoms of OSA www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=204
These CMS Decisions Will Lead to a Paradigm Shift in OSA Management What portable monitor should I use? Which patients should be tested? How should I incorporate portable monitors into my clinical management of OSA? Will non-sleep specialists be able to perform sleep testing? What s going to happen to my 20 bed sleep center?
2009 CMS Reimbursement Fees Metropolitan Philadelphia Type 1 CPT 95810; 95811 $842 - $928 Professional $178 - $192 Technical $664 - $736 Type 2 G code G0398 (unattended, home) $260 Type 3 G code G0399 (unattended, home) $248 CPT 95806 (unattended) $248 Professional $84 Technical $164 Type 4 HPCS code G0400 $222 www.cms.hhs.gov/pfslookup/02_pfssearch.asp?agree=yes&next=accept
Ambulatory Management Pathway Patients with Suspected OSA Sleep Clinic Evaluation In-lab (split night) polysomnogram Home sleep study AHI < 15 AHI > 15 on in-lab AHI > 15 on home AHI < 15 polysomnogram sleep study Clinic F/U In-lab manual CPAP titration Home AutoCPAP titration In-lab PSG Set home CPAP to in-lab CPAP titration Set home CPAP to AutoCPAP titration Home CPAP set-up CPAP adherence Functional Outcomes
Increasing the Utility of Portable Monitor Diagnostic Testing Minimize the number of negative studies Use in a patient population with a high pre-test probability of OSA minimizes the need for in-lab testing of patients with negative results Minimize the number of failed studies High failure rate inefficient, diverts patients to in-lab testing, and drives up cost Perform home unattended autocpap titration studies to identify the optimal CPAP setting
Alternate Methods of Titrating CPAP 360 Patients with Suspected OSA Diagnostic PSG AHI 30; ESS 12 Manual In-lab Titration (n = 107) To eliminate hypopneas, snoring and flow limitation Home Autoadjust (n = 106) One night at home with AutoSet-T. Repeat x2 prn Predicated Formula (n = 115) BMI, AHI, and Neck Circumference with domestic adjustment Outcome Measures following 12 weeks CPAP treatment: In-lab PSG (AHI), ESS, FOSQ, SF-36, EuroQOL Masa et al. AJRCCM 170: 1218-24, 2004
Nurse-led Care for Moderate-Severe OSA Assessed for eligibility (n = 1426) Randomized (n = 195) Standard MD/ PSG Pathway (n = 95) Nurse Led Pathway (n = 100) 3 month F/U (n = 84) 3 month F/U (n = 90) Antic et al. AJRCCM 179:501-8, 2009
Physician Polysomnography Home oximetry Nurse Ambulatory Diagnostic PSG CPAP titration PSG Physician visit Fixed CPAP commencement Nurse visit at set-up, 1 and 3 months Auto-CPAP CPAP commencement at fixed pressure Specialist Nurse visit at baseline, 1 and 3 months ESS, FOSQ, SF-36, MWT Neurocognitive Assessment CPAP adherence Antic et al. AJRCCM 179:501-8, 2009
Bootstrapped Joint Distribution of Incremental Costs and Effects per Patient Incremental effect (ESS per patient A vs B) -3-2 -1 0 1 2 3 - $1,000 - $1,200 Incremental cost (Aust $ per patient) Antic et al. AJRCCM 179:501-8, 2009
Veterans Sleep Apnea Treatment Trial Patients with Suspected OSA Sleep Clinic Evaluation In-lab (split night) polysomnogram Home sleep study AHI < 15 AHI > 15 on in-lab AHI > 15 on home AHI < 15 polysomnogram sleep study Clinic F/U In-lab manual CPAP titration Home AutoCPAP titration In-lab PSG Set home CPAP to in-lab CPAP titration Set home CPAP to AutoCPAP titration Home CPAP set-up CPAP adherence Functional Outcomes Medical Care Cost
Portable Spirometer Peak Flow Meter
Future Research Needed for Portable Monitor Testing Standardize the monitors and signals measured Perform adequately powered, high-quality studies to assess the monitors: In the home setting In patients with other cardiopulmonary diseases, different ethnic groups, and the elderly Assess the use of portable monitors on clinical outcomes (e.g. PVT, ESS, FOSQ) rather than AHI Perform prospective studies to assess the costeffectiveness of ambulatory management of OSA