Stefanos N. Kales MD, MPH, FACP, FACOEM HARVARD UNIVERSITY

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1 Sleep & Transportation Accidents Stefanos N. Kales MD, MPH, FACP, FACOEM HARVARD UNIVERSITY NECOEM / MaAOHN 2017 Newton, MA

2 Stefanos N. Kales MD, MPH, FACP, FACOEM DIVISION CHIEF, OCCUPATIONAL MEDICINE and MEDICAL DIRECTOR EMPLOYEE HEALTH & INDUSTRIAL MEDICINE CAMBRIDGE HEALTH ALLIANCE PROFESSOR of MEDICINE, HARVARD MEDICAL SCHOOL PROFESSOR and DIRECTOR, OCCUPATIONAL MEDICINE RESIDENCY, HARVARD TH CHAN SCHOOL OF PUBLIC HEALTH

3 Sleep & Transportation Accidents X I declare that neither I nor my spouse or partner has a relevant financial relationship with any commercial interest(s) related to the subject matter of the CME program. Learning Objectives: 1. Safety Risks of Fatigue on driving/ operating complex vehicles. 2. Common signs, symptoms and risk factors for obstructive sleep apnea (OSA) and other sleep disorders. 3. Effects that OSA and other sleep disorders may have on health and driving/ operating performance.

4 Safety Risks are a Public Health/Safety Issue MCMIS Fatal & Non-Fatal Crash Events CY 2012 CY 2013 CY 2014* (01/01/ /30/2014) Crashes 130, , ,428 Fatalities 4,397 4,416 3,865 Injuries 80,111 83,444 79,370 FARS Fatal Crash Events CY 2011 CY 2012 CY 2013 Vehicles Involved 3,901 4,098 4,207 Fatalities 4,068 4,228 4,270 Truck Crashes cause about 4,000 Deaths and 80,000 Serious Injuries each year in the US 10-30% of Crashes are Fatigue-related

5 Fatigue = Public Health/Safety Issue OSA is primary medical cause of EDS

8 Dr. Mark Rosekind

9 Medical and Behavioral Determinants of Fatigue and Sleepiness: + represents a factor medically favoring fatigue and sleepiness; - represents a factor medically favoring alertness FACTOR Case (Data) Comments Sleep disorder Other Medical Conditions Associated with Fatigue For example: Obesity, Diabetes Mellitus, Depression. Individual Vulnerability to Sleep Loss Alcohol, Drugs or Medications that promote fatigue EtOH, Sedatives, Hypnotics, othercns depressants Hours awake Acute sleep deficit Chronic sleep deficit Shift work or Jet Lag Time of Day Effect Time on Task Accident Circumstances suggest Fatigue/sleepiness Single vehiclerun offroad. Hitting stoppedvehicle, rear-ending. Lack of braking/evasive maneuvers. Admit sleeping

10 Metro-North crash: New York, December 2013 resulting in 4 deaths and injuries to 59 additional persons. The medical investigation revealed the engineer s post-accident diagnosis of severe, obstructive sleep apnea.

Engineer in Daze before NYC Train Crash Jennifer Peltz

William] Rockefeller had switched just weeks earlier from

in his hours and his circadian rhythms with regard to

11 Engineer in Daze before NYC Train Crash Jennifer Peltz and Jim Fitzgerald, Associated Press [Train driver William] Rockefeller had switched just weeks earlier from the night shift to the day shift, so he did have a change in his hours and his circadian rhythms with regard to sleep. Review of the case- many missed opportunities to diagnose his OSA

12 Rockefeller Schedule & Crash Crash BMI >36; RDI=65; Sedating Anti-Histamine Drive for Sleep Bed Time fatigue Wake-up Start Work Circadian Drive for Wake clock time (HH)

13 Medical and Behavioral Determinants of Fatigue and Sleepiness: + represents a factor medically favoring fatigue and sleepiness; - represents a factor medically favoring alertness FACTOR Case (Data) Comments Sleep disorder Other Medical Conditions Associated with Fatigue + Individual Vulnerability to Sleep Loss + + Severe OSA Obesity Complaints offatigue at PCP OFFICE Alcohol, Drugs or Medications that promote fatigue + Sedating Anti-histamine Hours awake - Acute sleep deficit? Chronic sleep deficit + Likely Shift work or Jet Lag + Time of Day Effect _ Time on Task Accident Circumstances suggest Fatigue/sleepiness + _ Singlevehicle runoffroad. Hitting stopped vehicle, rear-ending. Lack of braking/evasive maneuvers. Admit sleeping

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

15 Mexican Hat, Utah Jan 2008

17 An International Issue

18 What is Obstructive Sleep Apnea? What are the Consequences? Sleep-disordered Breathing: due to intermittent upper airway obstruction Nocturnal symptoms of OSA: disrupted sleep due sleep-disordered breathing: snoring, snorting, pauses in breathing Diurnal symptoms: excessive daytime sleepiness, psychomotor deficits, impaired vigilance, sleep attacks --Weight gain and adverse metabolic issues, DM, CVD, Stroke, Cognitive Issues, Decreased Quality of Life & Life Expectancy

19 Obstructive Sleep Apnea and Risk of Motor Vehicle Crash/Accidents Beyond case investigations and anecdotes, what is the evidence from controlled studies? 1. Effect of Untreated OSA on Crash Risk 2. Does Treatment of OSA Mitigate Crash Risk

20 Tregear et al. JCSM Obstructive Sleep Apnea and Risk of Motor Vehicle Crash: Systematic Review and Meta-Analysis. Reviewed 18 eligible studies (only 2 involving commercial drivers). Untreated OSA Increases the Risk of Crash by 1.2 to 5 Fold CPAP Decreases the Risk (Other Studies)

21 OSA Increases the Risk of Crash by ~2.5 Fold

Criteria- Sleep study via network of Clinics across US If sleep study positive, immediate

23 All drivers screened by questionnaire (SomniSage) and driver fitness medical examination (occ health conducts secondary review of all CDME exams) Drivers meeting Screening Criteria- Sleep study via network of Clinics across US If sleep study positive, immediate (same morning) education and Driverfriendly treatment APAP compliance tracked by nurses/safety department

24 Cases (drivers with OSA, n=1,613) were matched to controls (drivers screened as low probability of OSA) on driving experience-at-hire and job tenure at the time of the case s polysomnogram (PSG). Cases were grouped by treatment adherence: Full Compliance (n=682), Partial Compliance (n=571), or No Compliance (n=360).

25 Burks SV, et al. Non-Adherence with Employer-Mandated Sleep Apnea Treatment and Increased Risk of Serious Truck Crashes. SLEEP 2016

Figure 2: Predicted cumulative hazard of a preventable DOT-reportable crash by study sub-group (The predicted cumulative risk of having a preventable DOT-reportable crash as a function of job tenure.

26 Figure 2: Predicted cumulative hazard of a preventable DOT-reportable crash by study sub-group (The predicted cumulative risk of having a preventable DOT-reportable crash as a function of job tenure. For a driver who was inexperienced-at-hire and had a PSG/matching date at 26 weeks of tenure, broken out by treatment compliance subgroups for cases. Predictions are from the first robustness test model, the multivariate Andersen-Gill time-to-crash model on driver-week data.) Burks SV, et al. Non-Adherence with Employer-Mandated Sleep Apnea Treatment and Increased Risk of Serious Truck Crashes. SLEEP 2016

27 Burks SV, et al. Non-Adherence with Employer-Mandated Sleep Apnea Treatment and Increased Risk of Serious Truck Crashes. SLEEP How do the results translate to plain numbers? 3 Fleets of 1,000 drivers each operating for 1 year (about 100,000 miles): Never-adherent drivers will have 70 preventable, DOT-reportable crashes; Fully Adherent Drivers with OSA 14 similar crashes Control Drivers 14 similar crashes Untreated OSA leads to 56 additional, preventable crashes/ 1,000 drivers

28 Garbarino et al.: Work accidents in OSA Risk of occupational accidents in workers with obstructive sleep apnea: systematic review and meta-analysis. SLEEP 2016

29 Why is OSA so Common Now?

31 Who is at Risk for OSA? From Pack AI

34 US Federal Regulations Federal Agency Regulation/Recommendation Required / Recommended Reporting specifically related to OSA BMI Threshold for PSG Referral FMCSA No established medical history or clinical diagnosis of respiratory or neurological dysfunction likely to interfere with the ability to control and drive a commercial motor vehicle safely Do you have sleep disorders, pauses in breathing while asleep, daytime sleepiness, loud snoring? none FRA Minimum required standards reflect only hearing and vision. Recommended medical examinations include screening for sleep disorders none FAA Untreated OSA is a disqualifying medical condition. If a pilot is diagnosed with OSA, an AME must submit all pertinent medical information to the FAA. The FAA will then decide Not specified BMI > 40 (withdrawn) (High BMI is not disqualifying by itself) US Coast Guard Are of sound health; have no physical limitations that would hinder or prevent performance of duties or pose a risk of sudden incapacitation Relies on self-disclosure of a sleep apnea diagnosis. none

36 Bus Collision with Stopped Truck at Deaths & 31 Injuries (Interstate 10, CA, Oct. 23, 2016) Truck Driver fell asleep stayed stopped. 50 yo M # BMI=45 No Illness/Injury/MEDS 2-YR cert (later revoked, criminal c/o no exam done) (2017, BMI=46, 2-yr Cert) NTSB/HAR-17/04 Bus Driver Fatigued, took no evasive action. 59 yo M # BMI=38 No Illness/Injury/MEDS + Glu Urine (NO BS taken) Next Day Glu - 2-YR cert (Chiro) Post-Mortem: HgA1C=11.4%, U Glu >250

37 NTSB-Investigated Accidents: Preliminary Data Reports: N= 93 34% Highway / 66% Rail Cause= Operator Error: N=71 (78%) FATIGUE / OSA: 22% All accidents 28% Operator Error

38 Workplace-specific data have arrived and untreated OSA at least doubles the risk of accidents. Now, is the time for action that will improve the public safety and transport operators health.

39 This supplemental training course will cover: 1. Sleep Health and Safety; 2. Role of the Medical Examiner; 3. OSA and Other Sleep Disorders; 4. Common Sleep Medications.

40 Thank You! Discussion / Questions Kales et al 2017

Rest Stop #101. Sleep & Fatigue-What s the difference and what to do about it.

Rest Stop #101. Sleep & Fatigue-What s the difference and what to do about it. Rest Stop #101 This Photo by Unknown Author is licensed under CC BY-NC-ND Sleep & Fatigue-What s the difference and what to do about it. Presented by Mary Convey, Director of Key Accounts & Risk Mitigation