The Future of Sleep Medicine

Barbara Phillips, MD, MSPH, FCCP

April 2, 2011

Disclosures

• Consulting, speaking– Cephalon– Department of Transportation, FMCSA– PriMed funding from ResMed, Respironics

• Leadership position– American College of Chest Physicians– National Sleep Foundation– National Board of Respiratory Care

Sleep Medicine in the Future

• The prevalence and importance of sleep apnea are attracting attention

• Training and credentialing have changed• Diagnostic approaches are simplifying

and multiplying• Reimbursement will continue to fall.• Treatment approaches are changing• The field is vulnerable

Sleep Apnea vs Sleep Disorders

• Prevalence of common sleep disorders– Insomnia: 10-30%– Sleep Apnea: 5%– RLS: 10%– Narcolepsy: 0.05%

• Diagnoses of patients presenting to sleep centers (Coleman II, 2000)

– Sleep apnea: 67.8– RLS: 4.9%– Narcolepsy 3.2%

One Definition of Obstructive Sleep Apnea (OSA)

CPAP will be covered for adults with sleep-disordered breathing if:– AHI (or RDI) > 15 OR– AHI (or RDI) > 5 with (“mild, symptomatic”)

• Hypertension• Stroke• Sleepiness• Ischemic heart disease• Insomnia• Mood disorders

Apnea + Hypopnea Index (AHI), AKARespiratory Disturbance Index (RDI)

And Oxygen Desaturation Index (ODI)

• AHI = Apneas + Hypopneas

Total Sleep Time, in Hours

• RDI = AHI, more or less (may include RERA’s)

• ODI = Number of 4% desats/hr

• SDB = Sleep-Disordered Breathing (What you say when you are not sure what you are

including. May include snoring, RERA’s, oxygen desaturation)

SHHS’s AHI is really an ODI

• All events (apneas and hypopneas) required a 4% oxygen desaturation to be counted because

• It was not otherwise possible to achieve acceptable inter-rater reliability based on flow rate or arousals.

RERA: Respiratory Effort-related Arousal (Guilleminault, 1993)

A sequence of breaths characterized by increasing respiratory effort leading to an arousal from sleep which does not meet criteria for an apnea or hypopnea. These events must fulfill both of the following criteria: 1. Pattern of progressively more negative

esophageal pressure, terminated by a sudden change in pressure to a less negative level and an arousal

2. The event lasts 10 seconds or longer.UARS (Upper Airway Resistance Syndrome):

> 5 RERA’s per hour of sleep

What About “Simple Snoring?”• Snoring in pregnancy is associated with increased

hypertension and growth retardation, controlling for weight, age, smoking (Franklin, Chest, 2000)

• Snoring is associated with cognitive decline (Quesnot, J Am Geriatric Soc, 1999)

• Snoring medical students are more likely to fail exams, controlling for BMI, age, sex (Ficker, Sleep, 1999).

• Snoring is a risk factor for cardiovascular disease in women. (Hu, J Am Coll Cardiol 2000).

• Snoring is a risk for type II diabetes (Al-Delaimy, Am J Epidemiol 2002).

• Snoring women have faster progression of CAD (Leineweber C. Sleep 2004)

Severity Criteria Based on PSG From the American Academy of

Sleep Medicine (Sleep, 1999)

• “Mild” sleep apnea is 5-15 events/hr

• “Moderate” sleep apnea is 15-30 events/hr

• “Severe” sleep apnea is over 30 events/hr

• (“Events” includes apneas, hypopneas, and RERA’s)

Which Patient Has “Mild” OSA?

Patient 1 Patient 2

AHI (events/hr) 40 10

Apnea duration (secs) 10-22 10-90

Lowest Sa02 (%) 90 71

% REM on study 18 0

Arousals/hr 8 80

Cardiac arrhythmias none v tach

Disease is a Spectrum…

Sleep-Disordered Breathing is a Spectrum

Why Sleep Apnea Isn’t Going Away…..

SDB with Aging

Positive Berlin Scores(Heistand et al, Chest 2006)

0

5

10

15

20

25

30

35

18-29 30-49 50-64 > 65

Percentage at high risk by age category

CPAP for OSA: Benefits

• Improved cognitive function• Improved quality of life• Reduced daytime sleepiness• Reduced risk of automobile accidents• Reduced health care costs• Reduced blood pressure• Reduced cardiac arrhythmias• Improved glucose tolerance• Reduced mortality rate• Reversal of impotence

From JNC7…

Marin JLancet2005

Marin J

Lancet

2005

N=1751

Controlling for:

Smoking

ETOH

Weight

Pre-existing heart disease

Age

Hypertension

Lipid-lowering agents

Diabetes

SDB and Death in a Population-Based Study (Young T, Sleep 2008)

Left: Total sample of1522 SHHS participants and 18 year survivalRight: Sample excluding 126 participants who used CPAP

Increased Risk of Crash with OSA (FMCSA, 2007)

CPAP Treatment Reduces Crash Risk (FMCSA 2007)

Sleep Medicine in the Future

• The prevalence and importance of sleep apnea are attracting attention

• Training and credentialing have changed• Diagnostic approaches are simplifying,

and multiplying• Reimbursement will fall. A lot. • Treatment approaches are changing• The field is vulnerable

Two Issues for MD’s:Training and Credentialing

• Training (Fellowships)– More than 70 ACGME-accredited Sleep

Fellowships exist (www.acgme.org)

• Credentialing (Board Certification)– Two rounds of ABIM-recognized sleep

board examinations have been given (November 2007 and 2009)

– There is one more “grandfathering” round in 2011

– Then ACGME fellowship training will be required

Who is Eligible? (www.abim.org)

• The examination is open to diplomates in internal medicine, pediatrics, neurology, family medicine, psychiatry, or otolaryngology.

• CMS is establishing a physician specialty code for Sleep Medicine.

Training and Credentialing for Sleep Techs

• Currently, there is a chronic shortage of qualified sleep techs.

• Sleep tech licensing bills that require a RPSGT or RT credential have proliferated.

• Competition and acrimony have escalated between accrediting bodies– The NBRC now offers a Sleep Disorders Specialist

tech examination for RT’s (SDS).– AASM has announced a plan for a certifying exam

for techs.

How is the NBRC examination different than the RPSGT examination?

• The Specialty Examination for Respiratory Therapists Performing Sleep Disorders Testing and Therapeutic Intervention is for respiratory therapists already having earned the CRT or RRT credentials.

• Content of this specialty examination is focused on sleep focused testing and intervention conducted by respiratory therapists and requires respiratory therapy education for eligibility.

Comparison of the SDS and RPSGT Exam

What the Future Holds

• The NBRC has been accredited by the National Commission of Certifying Agencies (NCCA).

• This opens the door to acceptance as a credential for sleep laboratory accreditation through the AASM and the Joint Commission.

• The AASM’s entry on the scene will shake things up.

• This may help reduce the tech shortage. 35

Sleep Medicine in the Future

• The prevalence and importance of sleep apnea are attracting attention

• Training and credentialing have changed• Diagnostic approaches are simplifying,

and multiplying• Reimbursement will continue to fall. • Treatment approaches are changing• The field is vulnerable

How does this sound to YOU?

• “You have a life-threatening condition that can cause car crash, hypertension, stroke, cognitive dysfunction and many other consequences. Effective treatment is available. And, after several weeks, a couple of nights in the sleep laboratory, and several thousand dollars, we may be able to get you started on that treatment.”

Portable Monitoring (or oximetry) is to in-lab PSG as…

• CXR is to CT scan (lung cancer)

• Pre-post spirometry is to methacholine challenge (asthma)

• Fasting glucose is to oral glucose challenge test (diabetes)

Counting up sleepers..?

Just how do we do it…?

Really quite simple. There’s nothing much to it.

We find out how many, we learn the amount

By an Audio Telly-o-Tally-o Count.

We have a machine in a plexiglass dome

Which listens and looks into everyone’s home.

Theodore Geisel, 1962

Outcomes of Home-Based Diagnosis and Treatment of Obstructive Sleep Apnea

Chest 2010; 138: 257-263

• Home testing and autoCPAP resulted in the same results in sleepiness, adherence, blood pressure and QoL as in-lab testing.

• “It is really not about the technology; it is about the initial and then chronic care of the patient….” (Dr N Collop, editorial)

The Use of Clinical Prediction Formulas in the Evaluation of Obstructive Sleep Apnea

(Rowley J, Sleep 2000)

• Crocker et al, Am Rev Respir Dis 1990– age, BMI, witnessed apneas, hypertension

• Maislin et al, Sleep 1995– sex, BMI, age, snorting, snoring, witnessed

apneas

• Flemons et al, Am J Respir Crit Care Med, 1994– Neck circumference, hypertension, habitual

snoring, choking

• Viner et al Ann Intern Med 1991– Sex, age, snoring, BMI

The Berlin Questionnaire(Netzer et al. Ann Intern Med 1999)

• N=100• Multicenter trial• Berlin questionnaire: queries about snoring,

sleepiness, obesity, hypertension• Being identified as “high risk” predicted an

RDI > 5 – sensitivity 86 %– specificity 77 %– PPV 89 %

CPAP as a Therapeutic Trial (Senn O Chest 2006, n= 33)

• Autotitrating CPAP, 4-15 cm H20, was used as the therapeutic trial

• A successful trial was “yes” to– Are you willing to continue CPAP treatment?– Was objective CPAP use > 2 hours/night?

• All underwent PSG; sleep apnea was considered an AHI of > 10

• Excluded were those with CHF, OHS, underlying lung disease, prior CPAP Rx, psych or illness, language problems

• Those who were diagnosed with OSA on basis of TT had same outcomes as in-lab diagnosed.

A Few More Observations

• Most folks wind up on 10 + 2 cm H20 CPAP.

• Heavier people need more pressure

• Checking the mask may be more cost-effective than repeating the titration

• There is no substitute for following the patient clinically!

An Outrageous Premise

• The CPAP titration is a highly over-rated, overpriced, overused, frequently unsuccessful gimmick whose main function is to keep sleep lab beds full.

• Fewer titrations will be done, and this will be mostly for those with CSA.

Sleep Medicine in the Future

• The prevalence and importance of sleep apnea are attracting attention

• Training and credentialing have changed• Diagnostic approaches are simplifying,

and multiplying• Reimbursement will continue to fall. • Treatment approaches are changing• The field is vulnerable

2011 Reimbursement for Common Sleep Codes

The PSG Gravy Train

Enjoy the ride while it lasts!PRWestbrook

Sleep Medicine in the Future• The prevalence and importance of sleep

apnea are attracting attention

• Training and credentialing have changed

• Diagnostic approaches are simplifying, and multiplying

• Reimbursement will continue to fall.

• Treatment approaches are changing, and compliance with CPAP will improve

• The field is vulnerable

Coverage Beyond the 1st 3 MonthsContinued coverage of a PAP device beyond the

first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating physician must conduct a clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy.

Education Improves CPAP Adherence

• Education and visits improved adherence, but APAP did not (Damjanovic Eur Respir J, 2009)

• Patients value education about CPAP more than health care providers do (Brostrom A, Pat Educ Couns, 2009)

• Education can improve adherence in previously non-compliant patients (Ballard RD, JCSM, 2007)

• CBT can improved adherence (Richards D, Sleep 2007)

• Education improved adherence in a large number of French patients (Meurice JC, Sleep Med, 2007)

• Video education may help! (Wiese J, Sleep Med 2005)

Autotitrating CPAP(Ayas N, Sleep 2004)

• Most commonly, increases pressure to eliminate vibration of palate and soft tissue.

• Now costs about the same as “straight” CPAP.• May improve compliance.• Results in lower pressure over all.• Can obviate the need for in-lab titration, in many

cases.• Is supplanting in-lab titration

Compliance: APAP = CPAPMeurice

Series

Konermann

d’ Ortho

Hudgel

Teschler

Randerath

Massie

Planes

Combined

Use of APAP-CPAP (Hrs/day)10-1 2 3

Ayas, NT et al.Sleep 2004;27:249-53

-2

What About Blowers?

The autoadjusting, bilevel, ASV, self-cleaning, downloadable, full color, titratable, automatic transmission $6000 PAP machine has yet to prove itself, and maybe never will.

For Blowers, Simpler May be Better

Adjustable PM Positioner

Oral Appliances(Kushida C, Sleep 2006)

Indicated for patients with mild-to-moderate obstructive sleep apnea who

prefer oral appliances to CPAP do not respond to CPAP are not appropriate candidates for CPAP fail treatment attempts with CPAP (Kushida Sleep 2006)

Not as effective as CPAP Lower blood pressure 3-4 mmHg (Otsuka Sleep

Breath 2006)

Outperformed surgery in the only head-to-head trial.

Preferred to CPAP in head-to-head trials.

Do Oral Appliances Work?Cochrane Database Syst Rev. 2006 Jan 25;(1):CD001106.

“CPAP is effective in reducing symptoms of sleepiness and improving quality of life measures in people with moderate and severe obstructive sleep apnoea (OSA). It is more effective than oral appliances in reducing respiratory disturbances in these people but subjective outcomes are more equivocal. Certain people tend to prefer oral appliances to CPAP where both are effective. This could be because they offer a more convenient way of controlling OSA.”

• Nasal valves– Decreased AHI from 43 to 27, improved

Epworth in a small group of CPAP “failure” patients (Walsh JK, Sleep Med 2011)

– Reduced AHI by about 50% (compared with 10% for sham) in RCT of 250 people (Berry RB, Sleep 2011)

Sleep Medicine in the Future

• The prevalence and importance of sleep apnea are attracting attention

• Training and credentialing have changed• Diagnostic approaches are simplifying,

and multiplying• Reimbursement will continue to fall. • Treatment approaches are changing• The field is vulnerable

Who Will Practice Sleep Medicine?

• Sleep apnea is too prevalent to be managed by specialists.

• Many other sleep disorders lack established diagnostic criteria or treatment outcomes.

• Sleep apnea is well-managed by pulmonologists…who may not be interested in psychiatry. Or another examination.

• The field could split. Or dissipate.

The Future of Sleep Medicine? • Sleep apnea management will become bread

and butter primary care, like COPD or asthma.

• Portable monitoring and other tests will become the standard.

• Titrations will be rare. • Increasingly, the diagnosis of sleep apnea will

be made outside of sleep laboratories, maybe empirically on clinical grounds

• We will make less money.• Those patients who do go to the sleep center

will need precise, sophisticated testing; fewer, more sophisticated labs will exist.

Additional Resources

• www.sleepfoundation.org• www.aarc.org• http://www.aarc.org/sections/sleep/index.asp• http://www.abim.org/cert/aqsleep.shtm• www.chestnet.org• www.acgme.org• www.aasmnet.org• https://www.cms.hhs.gov• www.dot.fmcsa.gov