1. SLEEP APNEA AND THE COMMERCIAL DRIVER What’s New?
Kimberly Mebust, M.D.
Executive Medical Director
MultiCare Sleep Disorders Centers

2. Obstructive Sleep Apnea (OSA)
Recently, a primary care physician working in an urgent care setting evaluated a 35-year-old woman complaining of ear pain. She was diagnosed with otitis externa from trauma. She stated that she wore ear plugs each night because of her husband’s snoring.
Additional questioning revealed that her husband snored loudly with frequent pauses and gasps, which frightened her. Her husband was seen and examined by his primary care physician. He weighed over 250 pounds and had a shirt collar size of 18. A diagnosis of probable sleep apnea was made and the husband was referred for a polysomnogram.
Primary care physicians are commonly the first healthcare professional to have the opportunity to see patients with sleep apnea and their spouses. The informed physician can dramatically improve the patient’s quality of life. This talk will help you better understand the nature of the disorder, how it presents, and how to treat it.

3. Sleep Apnea Is a Breathing Disorder That Disrupts Sleep

4. There are Two Primary Types of Sleep Apnea
Obstructive Sleep Apnea and Central Sleep Apnea
Related breathing disorders:
Mixed Sleep Apnea
Upper Airway Resistance Syndrome

5. 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

6. Prevalence of Obstructive Sleep Apnea
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

7. What are the Symptoms of Sleep Apnea
Excessive daytime sleepiness
Snoring
Pauses in breathing

8. Pathophysiology of Apnea
This slide shows the effect of sleep on the upper airway in a sleep apnea patient. In the figure on the left, the patient is awake and the airway is narrowed but patent. The upper airway dilator muscles are responsible for maintaining the patency of the airway despite the reduced size of the airway, which may be due to fat deposition from obesity or structural abnormalities such as retrognathia. Note that collapse, shown on the right, may occur anywhere along the upper airway, from the retropalatal space to the hypopharynx, and often occurs in multiple places.

9. 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

10. 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

11. 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

12. Polysomnography
This slide shows the setup of equipment on a patient undergoing overnight polysomnography. Note the multiple EEG, EOG, EMG and respiratory electrodes required for full physiologic monitoring.

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

14. Positive Airway Pressure
This slide depicts the therapeutic effect of continuous positive airway pressure (CPAP). In the panel on the left, you can see upper airway closure in an untreated sleep apnea patient. Note that the airway closure is diffuse, involving both the palate and the base of the tongue. In the second panel, CPAP is applied and the airway is splinted open by the positive pressure.
69. Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet 1981;1(8225):

15. Nasal-Aire CPAP interface

16. 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

17. Snore cushion

18. Dental Appliances and Surgery May Be Helpful
Oral devices
UPPP
LAUP

19. Oral Appliance: Mechanics
There are several types of oral appliances available for the treatment of sleep apnea. This slide depicts a mandibular repositioning device. The oral appliance causes the mandible to move forward and the bite to open slightly. The effect of this mandibular repositioning is to enlarge the airway, reduce airway collapsibility and decrease airway resistance.82
The device also anchors the mandible so that contraction of the genioglossus muscle moves the hyoid bone forward rather than just opening the mouth.
Another proposed mechanism is the activation of upper airway muscles, although this has not been proven conclusively. In some patients, oral appliances are an effective treatment for sleep apnea.
82. Schmidt-Nowara W, Lowe A, Wiegand L, Cartwright R, Perez-Guerra F, Menn S. Oral appliances for the treatment of snoring and obstructive sleep apnea: a review. SLEEP 1995;18(6):

20. Uvulopalatopharyngoplasty (UPPP)
This slide depicts the uvulopalatopharyngoplasty (UPPP) surgical technique.
The panel on the left depicts the preoperative upper airway, demonstrating a long soft palate and the presence of palatine tonsils. The incision site is marked with the dotted line.
The panel on the right depicts the postoperative oropharynx, with amputation of the uvula, bilateral palatine tonsillectomy, and trimming and suturing together of the anterior and posterior tonsillar pillars.
89. Fujita S, Conway W, Zorick F, Roth T. Surgical correction of anatomic abnormalities in obstructive sleep apnea syndrome: uvulopalatopharyngoplasty. Otolaryngol Head Neck Surg 1981;89(6):

21. Laser-Assisted Uvulopalatopharyngoplasty (LAUP)
Slide 21
Level 2
This slide depicts a laser-assisted uvulopalatopharyngoplasty procedure.
The laser is shown and the area of resection is outlined. The procedure involves making two lateral incisions in the soft palate which induce retraction of the soft palate, and amputation of the uvula.91
Note that this procedure involves removal of less tissue than with a standard uvulopalatopharyngoplasty. Multiple sessions are frequently required in order to achieve satisfactory results, the elimination of snoring.
91. Carenfelt C. Laser uvulopalatopharyngoplasty in the treatment of habitual snoring. Ann Otol Rhinol Laryngol 1991;100(6):

22. Sleep Apnea
Good Night!

23. 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

24. 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

25. 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

26. 2006 Recommendations In-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)

27. 2006 Recommendations In-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

28. 2006 Recommendations Out-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

29. 2006 Recommendations Out-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

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)

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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)

39. 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

40. 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

41. 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

42. State 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

43. 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

44. 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

45. 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)

46. 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)

47. 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

48. What is Happening NOW?
The Federal Motor Carrier Safety Administration has taken NO action on the recommendations for sleep apnea evaluation

49. 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

50. 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

51. 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

52. 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

53. 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?

54. For More Information Contact:
National Sleep Foundation
1522 K Street, NW, Suite 500
Washington, DC 20009
(202)
or visit
For more information about sleep tips, sleep disorders, and how to combat drowsy driving write to the National Sleep Foundation for free brochures and fact sheets or visit its website at the following address.

55. Resources Philips Respironics website
Contains the link to the Summary of Proposed Federal Motor Safety Administration Guidelines and other resources