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The Multiethnic Study of Atherosclerosis- SLEEP STUDY

The Multiethnic Study of Atherosclerosis- SLEEP STUDY. Sleep Disorders Highly Prevalent and Under-Recognized. Short Sleep (< 7hrs): 40% of adults, increasing over time Sleep Apnea: 17% of adult population, increasing with obesity epidemic Insomnia: 20-25% of adults Shift work: 20%

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The Multiethnic Study of Atherosclerosis- SLEEP STUDY

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  1. The Multiethnic Study of Atherosclerosis- SLEEP STUDY

  2. Sleep Disorders Highly Prevalent and Under-Recognized • Short Sleep (< 7hrs): 40% of adults, increasing over time • Sleep Apnea: 17% of adult population, increasing with obesity epidemic • Insomnia: 20-25% of adults • Shift work: 20% • Sleep Apnea and Short Sleep More Prevalent in Poorer and Ethnic Minorities

  3. Sleep Disorders Impact Cardiovascular Health • Hypertension and Cardiovascular Disease • Arousals, sleep fragmentation may be key mediator • Diabetes and Insulin Resistance • Hypoxemia may be key mediator • Incident Stroke and Mortality • OR/RR: 1.5-3.0

  4. Sleep Disordered Breathing (Sleep Apnea, OSA) Repetitive episodes of partial or complete upper airway obstruction during sleep, associated with hypoxemia, snoring, daytime sleepiness

  5. Sleep Apnea Prevalence • Mild Sleep Apnea ~ 1 in 5 US adults • Moderate/Severe Sleep Apnea ~ 1 in 15 US adults • >85% with treatable disease undiagnosed • 2-3:1 Male:Female Predominance

  6. Coronary Artery Disease and OSA OR 2.9 for incident non-fatal CVD after multiple risk factor adjustment who declined CPAP Marin, Lancet 2005

  7. Increased Mortality with SDB > 2-fold Increased Mortality in Men < 70 years Punjabi. PLOS-2009

  8. Short Sleep and Health People getting < 6 hrs per sleep/night are at a more than 30% increased risk for: • Diabetes • Coronary heart disease • Mortality

  9. Shortcomings of Prior Studies • Prior cohort studies have limited objective measures of cardiac or vascular function • Limited data on atherosclerotic risk factors (lipids, inflammatory markers) • Limited minority representation (almost no Asians, few Hispanics) • Both PSG and Actigraphy rarely performed.

  10. Aims of the MESA Sleep Study To test whether ‘poor or disturbed sleep:’ *Sleep Disordered Breathing (SDB) * Sleep Deprivation * Fragmented Sleep * Periodic Limb Movements (RLS) * Shift work Are associated with: Cardiovascular risk factors (lipids, glucose, HTN) Subclinical CVD (heart dysfunction, CAC, IMT) CVD events (coronary artery, stroke)

  11. Opportunities Collecting Sleep Information In MESA Sleep Disorders are common and often unrecognized, especially in under-studied ethnic minorities Sleep Disorders (deprivation, sleep apnea) impact CV health Measuring sleep in MESA will provide indices that may better predict CV risk, providing explanatory information for known ethnic and gender differences in CVD. MESA’s unique measures of cardiac and vascular function combined with sleep measurements will allow an understanding of the role of sleep disorders in the pathogenesis of atherosclerosis, hypertension and congestive heart failure Enhanced use of genotyped material to identify variants for sleep disorders

  12. Exposures Assessment • Sleep Apnea and Hypoxemia • Sleep Duration (average, long, short; consistency) • Sleep Fragmentation: quality and architecture • Sleep Phase: When do you sleep; Circadian rhythm • Leg movements • Daytime Sequel • Sleepiness • Functional Impairment

  13. MESA’s SLEEP MEASUREMENTS • WRIST ACTIGRAPHY • 24/7 patterns of sleep/wake • POLYSOMNOGRAPHY (PSG) • Single night of neurophysiological monitoring-apnea, PLMs, sleep stages • Sleep Journal (Diary) • Subjective bed/wake times • Sleep Health Questionnaire (20 item) • Symptoms- sleep duration, snoring, insomnia, RLS, sleepiness, functional impact of sleep, circadian preference, shift work

  14. Targets and Accrual • 2500 MESA participants • Attempt to over-recruit minorities if participation rate is > 50% • 24-27 month accrual period • Up to 6 month lag from Core Visit • 3 to 6 participants per week

  15. Measurements Polysomnography: Overnight in-home monitoring (electroencephalograms, electrooculograms, airflow by thermocouple, thoracic and abdominal excursions, finger pulse oximetry, and ambient light sensor). Definitions: AHI (Apnea Hypopnea Index) Average number of Hypopneas and Apneas per hr of sleep Events must be  10 sec with a  4% Oxygen desaturation Arousal Index Average number of Arousals per hr of sleep Sleep Efficiency % of total time in bed spent asleep

  16. Polysomnography Considered “gold standard” Precise neurophysiological monitoring of multiple channels of data EEG, oximetry, airflow, effort, ECG, legs

  17. Profusion Signal Display

  18. Sleep Disordered Breathing

  19. Actigraphy • Devices used to measure movement • Wrist: Sleep-wake estimation • Piezoelectric Sensors measure digitized acceleration signals over 30 to 60 sec. • Algorithms convert average movement to sleep – wake “epochs” • Can be worn for days to weeks • Light (lux) data collected • 3 wavelengths • Time off wrist identified

  20. Periodic Limb Movements in Sleep • Leg or legs jerk every 20-40 seconds • Clustered in repetitive episodes • May cause arousals from sleep • > 5 episodes with arousal per hour of sleep CVD, Mortality, ADHD

  21. Sleep Diaries (Journals) • Used for > 30 yrs • Direct recording vs recall • Enhanced reliability –data over several nights • High correlation between diary sleep duration and: • Actigraphy (r=.95) • Lower correlation compared to single item Q (r=.27) • Used to help edit the actigraphy data

  22. MESA-Sleep Protocol Overview • In-home Sleep visit (1-180 days after Exam 5) • Prior to in-home Sleep visit (in clinic): • Set up equipment and supplies for in-home sleep visit • Actigraph • Somte PSG • Evening of in-home visit (in participant’s home): • Describe sleep procedures and obtain informed consent (?) • Review use of diaries and administer Sleep Questionnaire • Demonstrate actigraph and record first entry of sleep diary • Hook up participant for PSG/Complete signal verification form • Perform signal verification & check for any medical alerts • Provide instructions for equipment use and retrieval of equipment Begin PSG recording • Morning after in-home sleep visit (in participant’s home): • Retrieve Sleep Questionnaire and PSG equipment/Inquire regarding problems/Remind to continue to wear actigraph and complete diary

  23. Central Training • August 23-25 2010, Cleveland, OH • 12 Site RAs/Coordinators • Reading Center/Industry • Didactics • Sleep Background, Technical Approaches, Working In the Home, Data Transmission, Urgent Referrals • Practice, practice, practice……. • PSGs, actigraphy • Every participant observed to successfully perform actigraphy • One person/site observed for a certified PSG

  24. Quality Assurance Central Training and Defined protocol Certification Monitoring/feedback of adherence to protocol and performance From Home Form: Impedance values, Notes of any unusual events Completeness of Sensor Checks Duration of home visit From Local Data Retrieval Form: Number of channels with data Number of channels without Majority with “artifact” Number of channels > 3 hrs oximetry + airflow Number of studies needing to be repeated From RC Quality grade for each signal Quality grade for study interpretability Team work! —Monthly support calls

  25. Certification Requirements • Sleep Written Protocol Exam • PSG • Observed centrally and answer oral exams (or observed by a centrally trained tech) • 2 overnight non-participant practice study with good data. • All corresponding paperwork correctly completed. • Correct transmission to RC • Actigraphy • Describe Actiwatch procedure • Configure/initialize the watch properly • Retrieve and transfer data

  26. Urgent Referrals (action/review within 10 days of study) Sleep Apnea: AHI > 50 Severe Hypoxemia: %time < 85% > 10% TST Cardiac: New A-fib; Known A-fib with HR out of range (<50 or >120 for 2 consecutive mins); HR without A-fib: <30 or>150 for 2 consecutive mins;2nd or 3rd degree heart block; Acute ST segment; 3 beats or more VT

  27. Feedback • Weekly receipts and quality grades to sites • Studies scored within 4 weeks of receipt • Weekly sleep reports to CC • Generate merged ppt letter • Urgent Referrals within 72 hours of receipt • Site and CC

  28. To Do’s Complete supply orders Use each device at least once Complete written exams and certification IRB Translate questionnaires Practice questionnaire administration Suggested pilot

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