SLEEP APNEA AND THE COMMERCIAL DRIVER

What’s New?Kimberly Mebust, M.D.

Executive Medical Director

MultiCare Sleep Disorders Centers

Obstructive Sleep Apnea (OSA)

Sleep Apnea Is a Breathing Disorder

That Disrupts Sleep

There are Two Primary Types ofSleep Apnea

Obstructive Sleep Apneaand Central Sleep Apnea

Related breathing disorders:Mixed Sleep Apnea

Upper Airway Resistance Syndrome

Obstructive Sleep Apnea (OSA) Affects Many People—Most

Undiagnosed• Affects 18 million Americans

• Who is more likely to get OSA:– Obese people– Men, those with large necks, are at risk– Women, in menopause, are at risk– Those with a physical abnormality of the

upper airway

Prevalence of Obstructive Sleep Apnea

• 2.4-3.9 million licensed commercial drivers in the US

• Truck drivers with sleep apnea have up to a 7 fold increased risk of being involved in a motor vehicle crash

What are the Symptoms ofSleep Apnea

• Excessive daytime sleepiness

• Snoring

• Pauses in breathing

Pathophysiology of Apnea

OSA is Associated with Medical/Psychiatric and Safety

Problems• Headaches• Depression• Stroke • Cardiovascular disease

– High blood pressure– Heart Attack– Congestive heart failure– Atrial Fibrillation and other arrhythmias

• Diabetes• Driving drowsy• Accidents at home and work

Prevalence of Obstructive Sleep Apnea Amongst Truck Drivers

• Sponsored by the FMCSA and the American Transportation Research Institute of the American Trucking Association

• Among sample of commercial driver’s license holders:– 17.6% had mild sleep apnea– 5.8% had moderate sleep apnea– 4.7% had severe sleep apnea

OSA Is Diagnosed with an Overnight Sleep Study

• Measures brain waves, body

movements, blood-oxygen levels,

heart rates, snoring, and breathing

• Done at a sleep center or home

Polysomnography

• Continuous Positive Airway Pressure (CPAP) is the gold standard of treatment

Positive Airway Pressure

Nasal-Aire CPAP interface

Lifestyle Changes can Reduce the Severity of Sleep Apnea

• Lose weight

• Avoid alcohol and nicotine

• Do not use sleeping medications

• Try sleeping on your side

Snore cushion

Dental Appliances and SurgeryMay Be Helpful

– Oral devices

– UPPP

– LAUP

Oral Appliance: Mechanics

Uvulopalatopharyngoplasty (UPPP)

Laser-Assisted Uvulopalatopharyngoplasty (LAUP)

Sleep Apnea

Good Night!

Federal Regulations for Sleep Apnea Evaluation/Treatment

• US commercial drivers are required to undergo medical qualification examinations at least every 2 years

• Initial recommendations regarding evaluation and treatment of sleep apnea were introduced in 1991

Federal Regulations for Sleep Apnea Evaluation/Treatment

• Joint Task Force of the American College of Chest Physicians, American College of Occupational and Environmental Medicine and National Sleep Foundation published recommendations for Evaluation and Fitness For Duty for Commercial Drivers with Sleep Apnea in 2006

2006 Recommendations

• Truck drivers are medically qualified to drive IF driver meets either of the following:– No positive findings suggestive of sleep

apnea or any of the numbered in service evaluation factors

– Diagnosis of sleep apnea with documentation of CPAP compliance

2006 RecommendationsIn-Service

• In-Service Evaluation (truck driver can drive while work up in progress for up to 3 months)

• If Driver falls into any one of 5 categories:– History suggestive of sleep apnea (snoring,

sleepiness, witnessed apnea)– Two or more of the following:

• BMI of 35 or greater• Neck circumference of greater than 17 inches n men and 16

inches in women• Hypertension (new, uncontrolled, or unable to control with

less than 2 medications)

2006 RecommendationsIn-Service

• Epworth Sleepiness Scale greater than 10• Previously diagnosed sleep disorder,

compliance claimed, but no recent medical visits/compliance data available for immediate review (must be reviewed with in 3 month period), if found not compliant, then remove from service

• Apnea/hypopnea index more than 5 but less than 30 in a prior sleep study and no excessive daytime sleepiness (Epworth 10 or less), no motor vehicle accidents, no HTN requiring 2 or more agents to control

2006 RecommendationsOut-of-Service

• Immediate evaluation recommended and removal from service for any one of the following:– Observed unexplained excessive daytime sleepiness

(in waiting room or on examination) or confessed excessive sleepiness

– Motor vehicle accident likely related to sleep disturbance, unless evaluated for sleep disorder in the interim

– Epworth Sleepiness Scale of 16+ or FOSQ <18

2006 RecommendationsOut-of-Service

• Previously diagnosed sleep disorder:– Noncompliant with CPAP– No recent follow up with in the recommended

time frame– Any surgical approach with no objective follow

up – Apnea/hypopnea index of >30

2006 Screening Recommendations for Commercial Drivers with

Possible Obstructive Sleep Apnea• Diagnosis should be made by a physician

and confirmed by sleep study, preferably in an accredited sleep lab or by a certified sleep specialist

• A full night study should be done unless a split night study is indicated (for immediate treatment of severe sleep apnea)

2006 Treatment Recommendations

• First line treatment for CMV drivers with sleep apnea should be with positive airway pressure (CPAP or BiPAP or ASV)

• All drivers must use machines that can measure time on pressure

• A minimum acceptable average use of CPAP is 4 hours with in 24 hour period, but longer time is more beneficial

• Treatment should be started with in 2 weeks of study

2006 Treatment Recommendations

• Follow-up by a sleep specialist should be done after 2-4 weeks of treatment

• After approx 1 week of treatment, there should be contact between the patient and CPAP vendor, treating physician/provider (to ask about mask fit, compliance and to download smart card

• Ideally have an AHI</= 5 documented with CPAP with titration study or after surgery or with use of oral appliance, can have AHI </= 10 depending on clinical findings

2006 Treatment Recommendations

• At a minimum of 2 weeks but within 4 weeks of starting treatment, driver should be reevaluated by sleep specialist and compliance and BP measured

• IF driver compliant and BP improving, driver can return to work but should be certified for no longer than 3 months

• Older regulations required treatment for 4-8 weeks before returning to work

2006 Oral Appliance Treatment Recommendations

• Oral appliances should only be used as a primary therapy if AHI less than 30

• Before returning to service, must have follow up sleep study demonstrating AHI ideally less than 5 but can be 10 or less while wearing oral appliance

• All reported symptoms of sleepiness must be resolved and blood pressure must be improving or controlled

2006 Treatment Recommendations Using Weight Loss or Surgery

• Follow up sleep study with AHI ideally less than 5 ( but can be 10 or less) required to document efficacy

2006 Ongoing Assessment

• After patients have been on CPAP treatment for 3 months, they need to be seen by the physician to document compliance again

• After this, they must be certified annually• Retesting may not be required if sleep apnea is

adequately controlled using subjective reports and compliance data from machine– Multiple sleep latency testing no longer required

Sleep Apnea Screening Problems

• Talmadge et al. Journal of Occupational and Environmental Medicine 50:324, 2008– During screening evaluations with

questionnaires, no one answered yes to the questions on snoring and witnessed apnea

– Conclusion: • Cannot rely on any self-reporting for symptoms of

sleep apnea• An objective, independent method of identifying

patients with sleep apnea is needed

Do Truck Drivers Treat Their Sleep Apnea?

• Philip Parks, MD, MPH et al published study in Journal of Occupational and Environmental Medicine March 2009

• Over 15 months, 456 commercial drivers were examined from 50 different employers– 78 (17%) met screening criteria for suspected

sleep apnea (these drivers tended to be older, more obese, and have relatively high blood pressure)

Do Truck Drivers Treat Their Sleep Apnea?

• Of the 78 drivers, 53 were referred to have a sleep study– 33 did not comply with the referral and were

lost to follow-up– 20 were confirmed to have sleep apnea– Only ONE with confirmed sleep apnea

complied with treatment recommendations– Concern: It is possible that many of the 14

million American truck drivers have undiagnosed or untreated sleep apnea

What is Next?

• Increased risk of motor vehicle crashes for noncommercial drivers if there is:– Abnormal Epworth Sleepiness Scale– Degree of severity of sleep apnea based upon

AHI– Degree of oxygen desaturations in sleep– Body Mass Index (BMI)

• BMI independently predicts increase risk of crashes regardless of whether the person has sleep apnea or not

What’s Next?

• Can treatment with CPAP improve daytime sleepiness?– One study has suggested that CPAP can

reduce crash risk, as marked by a reduction in the Epworth Sleepiness Scale in noncommercial drivers

– To date, there have been no other studies providing data to demonstrate treatment reduces crash risk

2008-2009State of Regulations

• Federal Motor Carrier Safety Administration Medical Advisory Board – Called upon by congress to develop evidence based

guidelines for criteria for all medical conditions relevant to commercial drivers

– Established a medical expert panel on sleep apnea– Developed new standards for physicians doing

physical exams for drivers– Proposed web-based national registry of commercial

drivers

Issues at stake

• Regulations have come about for public safety

• Need to strike a balance between the commercial driver industry and public safety– Detection and treatment needed without the

mandate to stop working– Cannot rely on self reporting as part of

screening

Expert Panel Recommendations For Obstructive Sleep Apnea and Commercial Motor Vehicle Driver Safety

January 2008

• Lengthy 37 page document outlining specific guidelines for certification, evaluation, diagnosis, and treatment

• Changes from 2006:– Treatment for only 1 week required with

compliance data and improvement of symptoms as opposed to 2-4 weeks

– Oral appliance not acceptable for treatment since compliance cannot be measured

Expert Panel Recommendations For Obstructive Sleep Apnea and Commercial Motor Vehicle Driver Safety

January 2008

• Changes from 2006– Weight loss surgery acceptable for treatment as long

as CPAP used, weight loss occurs, repeat sleep study shows AHI >/= 10 and no longer sleepy

– Facial bone and tracheostomy ENT surgeries acceptable as long as follow-up sleep study done indicating AHI>/= 10 and patient continues to have yearly re-evaluations (since high incidence of reoccurrence of sleep apnea)

Expert Panel Recommendations For Obstructive Sleep Apnea and Commercial Motor Vehicle Driver Safety

January 2008

• BMI (Body Mass Index) recommended for use as screening for presence of obstructive sleep apnea– Expert panel subgroup voted using BMI of 33 or more

the trigger for evaluation for sleep apnea (24% of commercial drivers)

– Medical Advisory Board voted to use 30 or more instead (estimated 42% of commercial drivers)

– For those with BMI 30 or more, driver gets a conditional certification pending sleep study (max one month)

Expert Panel 2008 Recommendations

• Old guidelines did not feel home sleep studies acceptable, but now new guidelines approve the use as long as oxygen saturations, nasal pressure, and sleep/wake time are measured but concern that drivers would place the device on someone else and collect false data

What is Happening NOW?

• The Federal Motor Carrier Safety Administration has taken NO action on the recommendations for sleep apnea evaluation

NEW REGULATION CONCERNS 2009

– Owners of transportation companies are frightened because of liability (one company in US successfully sued because driver with OSA not on CPAP)

– Drivers are frightened about losing job• “Don’t ask, don’t tell appears to be the current

policy

– Need to strike a balance to protect the driver and to protect the public

What Will Regulation of Commercial Drivers With Sleep Apnea Look Like in the Future?

• Proposal to establish a National Registry of Certified Medical Examiners to ensure that physical qualification exams of commercial drivers are standardized

• The Medical Examiner would electronically submit name and numerical identification for each driver examined so that drivers will not “doctor shop” in order to get certified to drive

Summary

• Obstructive sleep apnea is a common problem• Obstructive sleep apnea may result in driving

drowsy and put the commercial driver and others at risk

• Efforts should be made to evaluate drivers for the presence of sleep disorders, especially obstructive sleep apnea

• Barriers for diagnosis, treatment, and certification need to be further evaluated

Summary--Problems

• Currently many certifying physicians do not know the guidelines so need education to perform certification properly at the least

• Commercial drivers may avoid relating symptoms to their physicians because of the fear that they will be pulled off of the job for weeks to months, or longer– So need to allow an acceptable way for drivers to relate

symptoms in order for work up to be done– Work up and return to work path must be easy and quick

• Documentation of compliance with treatment using smart machines and web-based databases is needed for oversight of treatment

The Ultimate Question

• Will the federal government (Federal Motor Safety Administration) ultimately mandate sleep apnea screening

• Or• Will there be other methods put into place

to provide the necessary screening and oversight of the transportation industry in sleep apnea evaluation, treatment and compliance with therapy?

For More Information Contact:

National Sleep Foundation1522 K Street, NW, Suite 500

Washington, DC 20009(202) 347-3471

or visit www.sleepfoundation.org

Resources

• Philips Respironics website– http://www.trucking.respironics.com/FMCSA– Contains the link to the Summary of Proposed

Federal Motor Safety Administration Guidelines and other resources

– www.fmcsa.dot.gov/rules-regulations/TOPICS/mep/report/Sleep-