1. Dealing with Sleepiness in Transportation Workers FACP, FACOEM Stefanos N. Kales MD, MPH, FACP, FACOEM MEDICAL DIRECTOR EMPLOYEE HEALTH & INDUSTRIAL MEDICINE CAMBRIDGE HEALTH ALLIANCE ASSOCIATE PROFESSOR, HARVARD MEDICAL SCHOOL ASSOCIATE PROFESSOR and DIRECTOR OCCUPATIONAL & ENVIRONMENTAL MEDICINE RESIDENCY, HARVARD SCHOOL OF PUBLIC HEALTH

2. Funding –Harvard School of Public Health, NIOSH Education and Research Center (ERC) –American College of Occupational and Environmental Medicine (ACOEM) –Federal Motor Carrier Safety Administration (FMCSA), U.S. Department of Transportation (DOT) –Respironics, Inc. –Consultant to Novartis

3. Bus Driver Rear-Ends Parked Bus 55-year-old male, 12 years school bus driver Students: “Driver ’ s head resting on steering wheel” while students boarding “Frequently dozed off at red lights and bus stops”

4. Fitness for Duty BMI 37 kg/m 2 Neck circumference >17 in Uncontrolled Hypertension (Stage 2) Polysomnography –Apnea-hypopnea index (AHI)=73 –Nadir SpO 2 =69% –28% sleep time SpO 2 <90%

5. “My uncle never crashed, but he frequently had to stop his truck and nap…. MD who did his DOT exam never asked about OSA or to have a sleep study. This went on for months until I finally convinced him to be tested… Thank God, Uncle Joe retired.” Uncle Joe’s Dump Truck Siestas

6. Why are Sleepy Drivers Important? Roughly 8-14 million Commercial Drivers License (CDL) holders in US Large proportion of motor vehicular crashes due to fatigue and/or sleep disorders. Estimates range from 10% to 30%.

7. Why are Sleepy Drivers Important? Large truck crashes: 50% lead to death or incapacitating injury > 5,300 deaths & >104,000 injuries/year from bus/truck crashes (DOT 2003-2007) (about One tenth of numbers for Flu in US)

8. Factors Affecting Operators & Sleepy Crashes Sleep Deprivation Poor Sleep Hygiene Travel/shift work Altitude Alcohol/Drugs Sleep medication Other Sleep disorders Obstructive Sleep Apnea Clinical Sleep Disorders

9. Dagan et al 2006 Israeli truck drivers with BMI >/=32 100% denied all symptoms of OSA/EDS 78% PSG-confirmed OSA & EDS by MSLT

10. Epworth SS = 0 Snow Plow Scott- CDL Form

11. Also had Severe OSA, Untreated Snow Plow Scott- PCP Progress Note

12. Intervention: Unrestricted sleep, sleep restricted to 4 hours, and vodka to achieve BAC 0.05 g/dL. Conclusion: OSA Patients more vulnerable than healthy persons to EtOH & sleep restriction on driving performance. Ann Intern Med. 2009;151:447-455. Results: OSA more steering deviations, slower braking, more crashes

14. Mexican Hat, Utah Jan 2008 Bus ran off the road killing 9 & injuring 43 NTSB: driver fatigue likely root cause Sleep apnea “trouble” using CPAP Altitude sickness & URI also likely interfered with his sleep

15. OSA Increases the Risk of Crash by 2-11 Fold

16. BMI > 29: RR of OSA >10 BMI >/=32: Chance of OSA ~75% 1980: 15% of US adults Obese 2000: 30% Obese 2018: 43% Will Be Obese

17. OSA prevalence in U.S. is 2-10% OSA prevalence in commercial drivers 17-28%

18. During naps, sleep latency & wake time were significantly lower in obese However, during nighttime testing, obese patients demonstrated significantly higher wake time Arch Intern Med. 1998.

19. BIXLER, E.O. et al. 2005. Excessive daytime sleepiness in a general population sample: the role of sleep apnea, age, obesity, diabetes and depression. J. Clin. Endocrinol. Metab.

20. Stoohs et al. Sleep 1994

21. US DOT Modal Administrations * http://www.fra.dot.gov/downloads/safety/hazmatch2.pdf

22. FMCSA Guideline for OSA * Narcolepsy and sleep apnea account for about 70% of EDS. Persistent or chronic sleep disorders causing EDS can be a significant risk to the driver and the public. The examiner should consider general certification criteria at the initial and follow-up examinations: –Severity and frequency of EDS –Presence or absence of warning of attacks –Possibility of sleep during driving –Degree of symptomatic relief with treatment –Compliance with treatment. * http://www.fmcsa.dot.gov/rules-regulations/topics/medical/faqs.aspx?FAQTypeSub=1010&FaqQ=#question2

23. FMCSA Guideline for OSA* ”Drivers should be disqualified until the diagnosis of sleep apnea has been ruled out or has been treated successfully, [unless] a CMV driver agree to continue uninterrupted therapy such as CPAP and undergo objective testing as required.” “A driver with a diagnosis of (probable) sleep apnea or a driver who has Excessive Daytime Somnolence (EDS) should be temporarily disqualified until the condition is either ruled out by objective testing or successfully treated.” * http://www.fmcsa.dot.gov/rules-regulations/topics/medical/faqs.aspx?FAQTypeSub=1010&FaqQ=#question2

24. FMCSA Regulations: “no established …respiratory dysfunction likely to interfere with the ability to control and drive a commercial motor vehicle safely.”

25. FAA Guidelines for OSA * 2010 Guide for Aviation Medical Examiners: page 71

26. FAA Guidelines for OSA AME Assisted Special Issuance (AASI) is a process that provides Examiners the ability to re-issue an airman medical certificate under the provisions of an Authorization for Special Issuance of a Medical Certificate (Authorization) to an applicant who has a medical condition that is disqualifying under Title 14 of the Code of Federal Regulations (14 CFR) part 67. An FAA physician provides the initial certification decision and grants the Authorization in accordance with Title 14 of the Code of Federal Regulations. The Authorization letter is accompanied by attachments that specify the information that treating physician(s) must provide for the re-issuance determination.

27. FAA Guidelines for OSA Examiners may re-issue an airman medical certificate under the provisions of an Authorization, if: 1. An authorization granted by the FAA; 2. a current report (performed within last 90 days) from the treating physician that references the present treatment, whether this has eliminated any symptoms and with specific comments regarding daytime sleepiness. 3. Maintenance of Wakefulness Test (MWT) will be required if questions on non-compliance or no response. The Examiner must defer to the Aerospace Medical Certification Division (AMCD) or Regional Flight Surgeons if: 1. There is any question concerning the adequacy of therapy; 2. The applicant appears to be non-compliant with therapy; 3. The MWT demonstrates sleep deficiency; or 4. The applicant has developed some associated illness, such as right-sided heart failure.

28. Deficiency in FAA Guidelines Does not screen for presence of OSA Does not ask questions concerning a history of OSA or symptoms (i.e. EDS) No guidance to AMEs for risk factors for sleep disorders that maybe related to OSA

29. Federal Railroad Administration (FRA) on OSA FRA requirement exam includes only tri-annual vision and hearing testing Additional medical exam is required when a) post- offer b) promotion to a safety-critical position, or c) when fitness-for-duty is questioned Most railroads have no written standards Only 3 entities (1 Class One Railroad Norfolk Southern + 2 commuter railroads: NJ Transit, Metro-North) require periodic medical exams * *http://www.fra.dot.gov/downloads/safety/hazmatch4.pdf *http://www.fra.dot.gov/Downloads/safety/hazmatexsum.pdf

30. USCG non-military on OSA

31. * http://www.fra.dot.gov/downloads/safety/hazmatch2.pdf

32. Joint Task Force OSA Guidelines Adapted from :Screening Recommendations for Commercial Drivers With Possible or Probable Sleep Apnea from Hartenbaum et al. J Occup Environ Med. 2006;48(9 Suppl):S4-S37. Drivers meeting one or more of the six criteria are considered to have OSA or probable OSA. Historical Findings 1. Snoring, excessive daytime sleepiness, witnessed apneas 2. MVA likely related to sleep disturbance (run off road, at-fault, rear-end collision) 3. Previous OSA diagnosis Epworth Sleepiness Scale 4. ESS score > 10 Physical Examination Findings 5. Sleeping in examination or waiting room 6. Two or more of the following a. BMI >/= 35 kg/m 2 b. NC > 17 inches in men, 16 inches in women c. Hypertension (new, uncontrolled, or unable to control with < 2 medications)

33. “New study supports mandatory screenings, prohibition of ‘doctor shopping’.”

34. n = 456 n = 378n = 78 n = 53 Referred for PSG Screened (+) * Screened (-) n = 13n = 7 n = 20 Total number of subjects with confirmed OSA ‡ n = 33 Lost to follow-up † Total number of drivers examined Underwent PSG and provided PSG results Positive for OSA by PSG n = 25 Not Referred for PSG Positive for OSA by Self-Report Admitted to past OSA diagnosis OSA Screening Flow Chart Parks et al. JOEM 2009

35. Subject Age (years) Gender BMI (kg/m 2 ) NC (inches) ESSSymptomsAHI Minimum O 2 Saturation Diagnosis* CPAP Compliance † 167Male35.2916.511Snoring11584PSG Not Provided 247Male46.1618.51Snoring10478PSG Not Provided 346Male40.6018.54Denied7586PSG Not Provided 452Male35.8917.05Denied7286PSG 3.6 hours/day 532Male35.7718.01Snoring7053PSG Not Provided 642Male38.6918.02Snoring7063PSG Not Provided 720Male35.1219.04Snoring4486PSG 0.13 hours/day 835Male43.1218.751Denied3674PSG Not Provided 945Male36.4417.53Snoring3483PSG 6 hours/day 1039Male37.4618.03Denied3486PSG Refused CPAP 1141Male33.6716.52Snoring3082PSG Not Provided 1241Male41.6518.010Snoring15 ‡ 82 ‡ PSG 1.27 hours/day 1345Female49.1918.251Denied1486PSG Refused CPAP 14 56 Male33.9418.505Denied1168PSG Did not tolerate CPAP 1527Male35.7318.58 Snoring, pauses in breathing 881PSG Not Provided 1653Male35.9818.50 Snoring, daytime sleepiness -- Self-report Not Provided 1727Male37.1017.54Denied-- Self-report Not Provided 1842Male41.9319.00Denied-- Self-report Not Provided 1958Male30.5617.01Denied-- Self-report Not Provided 20 50Male26.14--1Denied-- Self-report Not Provided Mean43.25--37.5217.973.35--48.9178.53-- Median43.50--36.2118.002.50--36.4082.00--

36. CharacteristicScreened (+) for OSA * and Diagnosis Confirmed † (n = 20) Screened (+) for OSA * but Diagnosis Unconfirmed p-value Referred for PSG but Lost to Follow-Up ‡ (n = 33) Not Referred for PSG (n = 25) Men – n (%) 18 (94.7)33 (100)24 (96.0)0.461 Independent Drivers – n (%) 2 (10.5)3 (9.1)7 (28.0)0.105 Age range – years 20-6725-6627-61-- Mean age – years (+/- SD) 43.25 (11.43)43.12 (11.26)42.80 (8.57)0.989 Mean BMI – kg/m 2 (+/- SD) 37.52 (5.22)36.92 (3.86)32.14 (3.69)<0.001 Mean NC – inches (+/- SD) 17.97 (0.78) (n = 19) 17.9 (1.01) (n = 32) 17.27 (0.98) (n = 23) 0.026 Mean SBP – mm Hg (+/- SD) 128.40 (15.24)126.73 (10.95)129.68 (13.05)0.682 Mean DBP – mm Hg (+/- SD) 79.30 (9.14)81.39 (6.07)84.56 (6.89)0.052 Mean ESS – (+/- SD) 3.35 (3.17)3.35 (3.02) (n = 31) 4.04 (3.36) (n = 23) 0.688 Comparison of subjects with + OSA screen: confirmed diagnosis vs. no confirmation of diagnosis by polysomnography.

37. Results - Summary Estimated PPV of JTF Criteria = 20/20 = 100% Subjective Criteria ~ little value Estimated prevalence of OSA in the study population: –12% (95% CI, 8.68-14.56%) – JTF criteria (BMI ≥ 35 kg/m 2) –18% (95% CI, 14.86-21.98%) - BMI ≥ 32 kg/m 2 Loss to follow-up rate 33 of 53 (62%); 95% diagnosed drivers non-compliant with CPAP

38. Talmage et al 2008 198 (13%) of 1443 CDME’s OSA screen + Subjective / Symptom Criteria low utility 134 underwent PSG, 95% had OSA 64 lost to f/u (32%)

40. N=552 MD’s performing CDME’s OSA Screening of Drivers 92% “important or very important” 6% “moderately important” 2% “slightly important or not important”

41. Survey of ACOEM Members Only 42% using the consensus guidelines or other formal protocol. Reasons for not applying guidelines: not aware (36%) too complicated (12%) potential to lose clients (10%) driver inconvenience (10%) Most physicians would consider applying consensus guidelines going forward 39% would do so only based on additional data 22% only if they became the “standard of practice”

42. MEP recommended: BMI >/=33 trigger referral for PSG MRB: BMI cut point >30 trigger referral for PSG MRB Motion carried four to one. Jan 2008

43. MBTA Crash Newton May 2008 Operator of striking train at high risk for undiagnosed OSA Operator failed to respond to signals and several opportunities to slow or stop train Likely because of a micro-sleep episode NTSB 2009

44. NTSB: Sleep apnea, fatigue from schedules contributed to tired “go!” pilots Captain and first officer overflew destination in Hawaii, inadvertently fell asleep while on autopilot 53-year-old pilot was diagnosed (after the incident) with severe obstructive sleep apnea

45. MBTA Newton May 2008: NTSB Recommendations on OSA To all U.S. Rail Transit agencies: Medical exams should elicit prior diagnoses of obstructive sleep apnea or other sleep disorders and presence of risk factors. Identify operators at high risk for OSA or other sleep disorders and require that such operators be evaluated and treated. NTSB 2009

46. All drivers screened by questionnaire and driver fitness medical examination (BMI & BP) Drivers meeting Screening Criteria- Sleep study via network of Clinics across US If sleep study positive, immediate (same morning) education and “Driver-friendly” treatment CPAP compliance tracked by nurses/safety department

47. Results among Drivers with OSA who were treated: Saving of $578/driver/month in medical costs 30% decrease in fatigue-related crashes Higher retention of drivers with company

48. Dunlap v. Logan Trucking Company Truck driver struck another vehicle head-on, killing the other driver. Evidence showed the truck driver falling asleep at the wheel “Sudden Medical Emergency” Defense.

49. Dunlap v. Logan Trucking Company Court concluded: he knew or should have known that falling asleep at the wheel was a potential risk given his health conditions. Both truck driver and employer were found partially liable for the accident.

50. Conclusions OSA prevalence high across studies. Drivers under-report sleep disorders Low compliance with PSGs referrals and CPAP treatment suggest Doctor-Shopping Most OSA cases unreported, undiagnosed, or untreated & contribute to significant public safety risks

51. Conclusions Screening Criteria must be OBJECTIVE and SIMPLE (i.e. single BMI cutoff) Authorities should mandate OSA screening & Prohibit Doctor-shopping Cost, access, wait times, and insurance status are significant barriers to many commercial drivers Employer-based solutions can be very effective Education of MD’s, Drivers, Trucking Companies & Insurers Needed

52. Final Case- School Bus Driver

53. BMI 32 kg/m 2 Neck circumference 17.5 in Uncontrolled Hypertension (Stage1 & 2) Denies All Symptoms; ESS = 0 Polysomnography –AHI=11; Supine AHI and REM AHI both 24 –Nadir SpO 2 =93% –Loud Snoring –Sleep Efficiency 60%

54. Kales et al 2010 Thank You! Discussion / Questions