PatrickJ$Strollo,$Jr,$MD,$FACP,$FCCP,$FAASM … · Outline:$Benefits$of$CPAP$ • Background$ •...
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CPAP Benefits for OSA
Patrick J Strollo, Jr, MD, FACP, FCCP, FAASM Professor of Medicine and Clinical and Transla<onal
Science Medical Director, UPMC Sleep Medicine Center
University of Pi.sburgh / CTSI / Clinical + Transla<onal Science Ins<tute
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Disclosure: Patrick J Strollo, Jr., MD Research Support • Federal
– R01 HL107370 – RO1 DK096028-‐02 – RO1 HL120354-‐01A1 – 1UH2HL125103-‐01 – 5UL1TR000005-‐09
• State – PA DOH MD-‐02-‐384
• Industry – Research Grant Philips-‐Respironics, Inc. – Research Grant ResMed, Corp. – Inspire Medical Systems – Na<onal Football League – PinMed
• Founda<on – American Sleep Medicine Founda<on
Industry advisory: -‐ ResMed -‐ Philips-‐Respironics -‐ Emmi Solu<ons -‐ Jazz Pharmaceu<cals
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Outline: Benefits of CPAP
• Background • Metabolic / Type II DM • Neurocogni<ve / Accidents • Cardiovascular • Healthcare u<liza<on • Summary / Conclusions
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Untreated OSA Results in Major Economic Cost
4
The Price of Fa<gue, Harvard Medical School, Division of Sleep Medicine, 2010 healthysleep.med.harvard.edu/file/20
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Sleep Apnea is Associated with Significant Co-morbidities
Cardiovascular Complications
Metabolic Complications
Neuro-cognitive Complications
* Non-‐propor<onal Venn diagram
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Outline: Benefits of CPAP
• Background • Metabolic / Type II DM • Neurocogni<ve / Accidents • Cardiovascular • Healthcare u<liza<on • Summary / Conclusions
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Effect of CPAP on Insulin Sensi<vity
• Subjects 34 m / 6 f • Age 53.8 + 11.8 • BMI 32.7 + 6.9 • No Diabetes • Insulin sensi<vity measured
by euglycemic clamp
Insulin
Sen
si<v
ity In
dex
Baseline 2 Days 3 Months 0 2 4 6 8 10 12
AJRCCM 2004 169:156-‐62
p < 0.001
p < 0.001 n.s.
Greatest effect on subset BMI < 30
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Impact of CPAP on HbA1c: Analysis of UK THIN Database
Diabetes Care 2014;37:1263–1
n = 150 n = 150
CPAP adherence was a mean of 5.8 to 6 1.0 h per night (range 4.0–7.2) for 11 pa<ents*
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Associa<on of OSA in REM Sleep With Reduced Glycemic Control in Type 2 DM: Rx Implica<ons
• Aim: To quan<fy the impact of OSA in REM versus NREM sleep on HbA1C in subjects with type 2 DM
• Design: Prospec<ve cohort. All par<cipants underwent PSG, and glycemic control was assessed by HbA1C
• Results: n = 115 (65 women) 55.2 + 9.8 yrs, BMI 34.5 + 7.5 kg/m2. Mul<variate linear regression model, REM AHI was independently associated with increasing levels of HbA1C (P =0.008).
• Conclusions: OSA during REM sleep may influence long-‐term glycemic control. The metabolic benefits of CPAP therapy may not be achieved with the typical adherence of 4 h per night.
Diabetes Care 2014 37:3555-‐363
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Associa<on of OSA in REM Sleep With Reduced Glycemic Control in Type 2 DM: Rx Implica<ons
Diabetes Care 2014 37:3555-‐363 Adjusted for age, sex, race, BMI, years of Type 2 DM, and insulin use
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Cumula<ve min of REM and NREM over 8 h of bed<me
Diabetes Care 2014 37:3555-‐363
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Outline: Benefits of CPAP
• Background • Metabolic / Type II DM • Neurocogni<ve / Accidents • Cardiovascular • Healthcare u<liza<on • Summary / Conclusions
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The Apnea Posi<ve Pressure Long-‐term Efficacy Study (APPLES)
Aim: To assess its efficacy on neurocogni<ve func<on in pa<ents with OSA across a range of disease severity. Design: Prospec<ve randomized, double-‐blind, 2-‐arm, sham-‐controlled, mul<center, long-‐term (6 months) trial of CPAP therapy
Sleep 2012 35:1593
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APPLES: No Improvements in Subjec<ve or Objec<ve Sleepiness in Mild to Moderate OSA
Sleep 2012 35:1593
PAP n = 551 Sham n = 535
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APPLES: No Improvements in Neurocognitive function with OSA Rx
• No significant changes in – Agen<on and Psychomotor Func<on
(Pathfinder Number Test) – Verbal Learning and Memory (Buschke
Selec<ve Reminding Test Sum Recall) – Execu<ve and Frontal Lobe Func<on
(Sustained Working Memory Test)
• No differences by severity of OSA • Only transient improvements in
Execu<ve and Frontal Lobe Func<on at 2 mo seen in pa<ents with severe OSA and did not persist at 6 mo
Sleep 2012 35:1593 n = 1098
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CPAP Treatment of Sleepy Pa<ents with Milder OSA: Results of the CATNAP Randomized Clinical Trial
• Sleepy pa<ents with mild and moderately severe OSA had greater func<onal improvement aier 8 weeks of CPAP therapy compared to sham CPAP.
• Compared to placebo, CPAP treatment also produced clinically meaningful changes in mood and self-‐reported day<me sleepiness.
• As a mul<site study conducted at large and smaller clinical prac<ce sites, the results are highly generalizable and indicate the efficacy of this therapy in trea<ng sleepy pa<ents with less severe OSA. AJRCCM 2012 186:677-‐83
*
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Incidence of motor vehicle accidents (MVAs) per 1,000 individuals per year before and aier CPAP
SLEEP 2015;38(3):341–349
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Outline: Benefits of CPAP
• Background • Metabolic / Type II DM • Neurocogni<ve / Accidents • Cardiovascular • Healthcare u<liza<on • Summary / Conclusions
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Sleep 2008 31:1071-78
Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort (n = 1396)
• SDB, irrespec<ve of EDS, was associated with increased mortality. • The striking high CV mortality risk in untreated severe SDB, suggests that SDB Rx should not be con<ngent on day<me sleepiness symptoms
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Cumula<
ve In
cide
nce of Fatal CV Even
ts
Cumula<
ve In
cide
nce of Non
-‐fatal CV Even
ts
AIM: Observa<onal study to compare incidence of fatal and non-‐fatal cardiovascular events in simple snorers, pa<ents with untreated OSA, pa<ents treated with CPAP, and healthy men recruited from the general popula<on. Design: Prospec<ve observa<onal cohort. 264 healthy men, 377 simple snorers, 403 with untreated mild-‐moderate OSA (AHI 5-‐30), 235 with untreated severe OSA (AHI > 30), and 372 with OSA and treated with CPAP
Lancet 2005 365: 1046–53
Months Months
.
Conclusion: In men, severe OSA significantly increases the risk of fatal and non-‐fatal cardiovascular events. CPAP treatment reduces this risk.
Long-‐term cardiovascular outcomes in men with OSA
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OSA is associated with CV Mortality in Women & Treatment Modifies This Risk
Conclusion: Severe OSA is associated with cardiovascular death in women, and adequate CPAP treatment may reduce this risk.
Ann Intern Med. 2012;156:115-‐122.
n = 1116
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24 Hour BP Before and Aier 1 Month of CPAP, Therapeu<c Versus Sub-‐therapeu<c
Mean bloo
d pressure (m
mHg
)
Time from wake and sleep onset (hours)
Mean bloo
d pressure (m
mHg
)
Time from wake and sleep onset (hours)
Before Treatment Aier Treatment
Lancet 2002 359:204 -‐10
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Effect of CPAP on 24-‐h mean blood pressure in OSA
Treatment with CPAP promoted significantly but small reduc<ons in blood pressure in individuals with OSA. Further studies should be performed to evaluate the effects of long-‐term CPAP and the impact on cardiovascular risk.
Journal of Hypertension 2014, 32:1762–1773
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Mean change in 24-‐h DBP from RCTs in Resistant HTN
• The pooled es<mate shows a favorable reduc<on of BP with CPAP treatment in pa<ents with resistant hypertension and OSA.
• The effect sizes are larger than those previously reported in pa<ents with OSA without resistant hypertension
J Hypertens 2014 32:2341–2350
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Outline: Benefits of CPAP
• Background • Metabolic / Type II DM • Neurocogni<ve / Accidents • Cardiovascular • Healthcare u<liza<on • Summary / Conclusions
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Hospital Stays: Men Physician Claims: Men
SLEEP 1999 22:740-‐47 SLEEP 2006 29:1307-‐11.
Physician claims: Women Ambulatory clinic visits: Women
Healthcare U<liza<on with OSA 2 Years Aier Diagnosis and Treatment
Diagnosis
Diagnosis
Diagnosis
Diagnosis
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Outline: Benefits of CPAP
• Background • Metabolic / Type II DM • Neurocogni<ve / Accidents • Cardiovascular • Healthcare u<liza<on • Summary / Conclusions
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Summary
• Observa<onal data demonstrate a posi<ve treatment effect on: – Metabolic risk – Insulin sensi<vity / HbA1c
– Neurocogni<ve risk – FOSQ / MVA – Cardiovascular risk – Fatal and Nonfatal MI – Healthcare U<liza<on
• Randomized Control Trials – Cardiovascular risk – Blood pressure / Cardiac remodeling
– Mortality / Morbidity?
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OSA RCTs: CV Outcomes (Secondary Preven<on)
Study Popula<on Interven<on n Recruitment Status
CANPAP Systolic HF CPAP vs UC 258 Complete
RICCADSA Revascularized CAD
CPAP vs UC* * Four groups
400 Complete
SAVE CAD CPAP vs UC 2717 Complete
SERVE-‐HF Systolic HF ASV vs UC ~1200 Complete
ADVENT -‐HF
Systolic HF ASV vs UC 860 Ac<ve
UC = Usual Care
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CPAP Therapy and Adherence PAP therapy when used consistently results in decreased day<me sleepiness*, improved HRQOL, and decreased vascular risk. Recent studies of CPAP therapy inves<gated adherence:
• APPLES Study – largest RCT in sleep medicine to date (1,516 subjects enrolled) and CPAP adherence rate was 39% at 6-‐months use of CPAP therapy (174 of 443)
• Home PAP Study – Evalua<on of standard OSA care vs. home-‐base diagnos<cs and <tra<on. Results of 3-‐month follow-‐up: CPAP adherence was 39% (Lab <tra<on); CPAP adherence was 50% (Home <tra<on)
Conclusion: • CPAP is first-‐line therapy and effec<ve when consistently used by OSA pa<ents.
• Alterna<ve therapy op<ons for moderate or severe OSA pa<ents who are nonadherent to PAP are desirable
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0
5
10
15
20
25
30
0 10 20 30 40 50 60 70 80 90 100
Epw
orth
Sle
epin
ess
Scal
e
Apnea – Hypopnea Index
The Relationship of Self Reported Sleepiness to Sleep Apnea
n = 4653
Non-Sleepy Sleep Apnea
Sleepy Sleep Apnea
J Clin Sleep Med 2010 6:196-204
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Future Research & Management
• Diagnos<c classifica<on – Clinical phenotypes – Sleepy vs Non-‐Sleepy Endotypes
• Management – U<lity of Advanced Posi<ve Pressure Devices – Op<mal treatment dura<on*
• Impact of co-‐morbid condi<ons – Cardiac compromise (R & L* Heart Failure) – Insomnia – Insufficient sleep (independent of sleep fragmenta<on) – Obesity
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NATURE 2010 463: 258-259
Thank You
University of Pi.sburgh / CTSI / Clinical + Transla<onal Science Ins<tute
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Physiologic Phenotyping in OSA
• Upper Airway Anatomy/Collapsibility: – Posi<ve Airway Pressure, Dental appliances, Upper Airway Surgery.
• The Upper Airway Response: – Unilateral Hypoglossal Nerve S<mula<on
• Arousal Threshold to a Respiratory S<mulus: – Hypno<cs (eszopiclone and trazodone)
• Loop Gain (Ven<latory Control Instability): – Both oxygen and acetazolamide can lower loop gain.
Semin Respir Crit Care Med 2014;35:621–628
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Obstruc<ve Sleep Apnea and Type II Diabetes
• Up to 40% of people with OSA have diabetes, the incidence of new diabetes in people with OSA is not known.1
• In people who have diabetes, the prevalence of OSA may be up to 23%2
• The prevalence of some form of sleep disordered breathing may be as high as 58%.3
• Overweight and obesity may play a role, recent studies show an associa<on between the two condi<ons that is independent of overweight/ obesity.
• OSA may have effects on glycemic control in people with type 2 diabetes.
1Eur Respir J 22(1): 156-‐160, 2003 2Thorax 61(11): 945-‐950, 2006 3Diabetes Care 26(3): 702-‐709, 2003
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OSA and Cardiovascular Disease
• Primary HTN: 35% prevalence • Drug-‐resistant HTN: 65 to 80% prevalence
– Most common secondary cause
• Coronary Artery Disease: 30% prevalence • Heart failure: 21-‐37% prevalence • Atrial Fibrilla<on: OSA present 5 X more likely • Stroke: 60% prevalence
Circula<on 2012;126:1495-‐1510
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Interven<onal RCTs
• No published large scale interven<onal RCTs on benefit of OSA treatment on CVD/Mortality
• RICCADSA: Randomized Interven<on with CPAP in Coronary Artery Disease and Sleep Apnoea – 400 CAD ppts: 100 each to 1) non-‐sleepy OSA/CPAP, 2) non-‐sleepy OSA/no CPAP, 3) sleepy OSA/CPAP, 4) CAD but no OSA
– Follow-‐up for 3 years for CVD morbidity and mortality
Scand Cardiovasc J. 2009 Feb;43(1):24-‐31
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Sleep Apnea Cardiovascular Endpoints Study
• Mul<na<onal randomized, controlled trial to determine the
effects of nasal con<nuous posi<ve airway pressure (CPAP) in preven<ng cardiovascular (CV) disease in high risk pa<ents with moderate-‐severe obstruc<ve sleep apnea (OSA)
• Par<cipants randomized to CPAP or Op<mal medical care • Follow-‐up for 3-‐5 years (avg 4 yrs) • 2717 randomized by Dec 2013 • Sites (n = 89) in China, Australia, New Zealand, India, USA,
Spain and Brazil • Primary Endpoint: Composite of CV death, MI, HF, and
ischemic stroke (hospitaliza<on)
Jointly funded by Philips Respironics (unrestricted grant) and the Australian Na<onal Health and Research Council. Equipment Grants from ResMed & Compumedics NCT00738179
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Aim: Demonstrate that ASV therapy over minimum two years can improve morbidly and mortality in HF patients with predominately CSA Design: RCT with n = > 1300 (78 centers)
• Control arm: Optimal medical care
• Active arm: Optimal medical care plus ASV
Status: Enrolment complete (2013)
Funded by ResMed NCT00733343
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HF patients ≥ 18 yrs of age with LVEF ≤ 45% on optimal HF therapy, undergo a sleep study
ADAPTIVE-‐SERVO VENTILATION FOR TREATMENT OF OSA AND CSA IN HEART FAILURE
AHI ≥ 15 (≥ 50% obstructive = OSA, >50% central = CSA)
Randomization
Control – no ASV, n = 430 ASV – titrated on sleep study to eliminate OSA and/or CSA, n = 430
Baseline QOL, NT-pro-BNP, 6MWT, LVEF, LVEDV and LV mass
• 1 month clinic visit, sleep study and QOL • 3 month clinic visit • 6 month clinic visit, QOL, NT-pro-BNP, 6MWT, LVEF, LVEDV and LV mass • 6 monthly clinic visits and QOL until end of trial at 60 months • Primary outcome is the composite endpoint of deaths, and CV hospitalizations over the follow-up period • Endpoint is 540 primary events which we estimate will require a 3-year accrual time with minimum and maximum follow up times of 2 and 5 years • 2 interim analyses after 50% (n=270) and 75% (n=405) of the predicted number of primary events have occurred
Jointly funded by CIHR and an unrestricted grant fro PHILIPS/RESPIRONICS NCT01128816
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Effects of Con<nuous Posi<ve Airway Pressure on Cardiac Remodeling
A-‐D, Serial improvement in RAVI (A), RVEDD (B), RVEDVI (C), and LVMI (D) by either transthoracic echocardiography (A, B) or cardiac MRI (C, D)
LVMI = lem ventricular mass index; RAVI = right atrial volume index; RVEDD = right ventricular enddiastolic diameter; RVEDVI = right ventricular end-‐diastolic volume index CHEST 2012; 141(3):674–681
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Observational trials in untreated OSA is associated with
• Prevalent1 and incident2,3 hypertension • Prevalent and incident CAD4 and CHF5
• Cardiac arrhythmias6 and sudden death7 • Stroke8 • Pulmonary HTN9
1JAMA 2000 283(14): 1829-1836 2 AJRCCM 2009 179:1159-1164 3JAMA. 2012 307(20):2169 4Circ 2010 122:325-60 5AJRCCM 2001 163:19-25 6AJRCCM 2006 170:910-16 7NEJM 2005 352:1206-14 8AJRCCM 2010 182: 269-77 9Prog Cardiovasc Dis 2009 51:369-70
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Progress in ADVENT-‐HF
• 33 ac<ve sites ini<ated in: – Canada, – USA – Spain, – Germany – UK – Italy – Brazil
• 271 pa<ents randomized as of August 26, 2014 (about 50% of predicted rate)
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Conclusions • Substan<al progress has been made in the past 25-‐30 years in our understanding of the OSA/CVD rela<onship
• Accumula<ng evidence implicates SDB as an independent risk factor for hypertension, CHD and Stroke
• Risk may not be the same for all segments of the popula<on
• Treatment appears to mi<gate the risk in some clinical popula<ons
• Unclear whether treatment is beneficial in pa<ents without symptoms
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Sleep Apnea / Hypopnea
Clin Chest Med 2003 24:307–313
Differential susceptibility to daytime sleepiness
Differential susceptibility to vascular risk
The variable effect of OSA on physiologic outcomes
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Impact of CPAP CVD
• Hypertension – Does treatment of OSA reduce incident hypertension? – In whom does treatment of OSA significantly lower BP?
• Coronary Heart Disease/CHF/Stroke – Does treatment of OSA decrease risk of CHD/CHF/Stroke? – What treatments will be effec<ve?
• Mortality – Does treatment of OSA decrease mortality risk?
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CPAP Might Prevent HTN or CVD in Non-Sleepy OSA Patients
• Pa<ents with mostly severe OSA recruited • Benefits seen only if adherent to CPAP
Barbe F, et al. JAMA 2012: 307:2161.
© 2015 American Academy of Sleep Medicine 11
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CPAP Might Improve Blood Pressure in Non-Sleepy OSA Patients with Hypertension
• Pa<ents with mostly severe OSA recruited • Benefits seen only poten<ally seen if adherent to CPAP (>5.65h/night)
Barbe F, et al. JAMA 2012: 307:2161.
© 2015 American Academy of Sleep Medicine 12
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OSA is only associated with mortality in those with severe OSA
Sleep Heart Health Study
Amer adjustments for age, race, BMI, smoking status, blood pressure, prevalent hypertension, diabetes, and CVD.
© 2015 American Academy of Sleep Medicine
Wisconsin Cohort
Table 6 —Mortality Risk* With Untreated Sleep-Disordered Breathing (n = 1396)** Baseline AHI All-cause Cardiovascular category mortality mortality Hazard Ratio Hazard Ratio
(95% CI) (95% CI) None: 0 - < 5 Reference Reference
Mild: 5 - < 15 1.4 (0.7, 2.6) 1.3 (0.4, 4.1) Moderate: 15 - < 30 1.7 (0.7, 4.1) 1.5 (0.3, 7.3) Σεϖερε: 30 3 8 (1 6 9 0) 5 2 (1 4 9 2) P trend = 0.004 P-trend = 0.03
*Hazard ratios adjusted for age, age2, sex, body mass index, and body mass index2
**126 persons who reported usual use of continuous positive air πρ σσυρε Χ Α Π) 4 νιγη σ περ ω εε ερε εξχλυδεδ φροµ σ µπλε AHI denotes number of apnea and hypopnea events per hour of σλεεπ ΧΙ δενοτ σ χον ιδνχε ιντ ρϖαλ
Punjabi NM, et al. PLoS Medicine 2009; Young TB, et al. Sleep 2008; 31: 1071.
14
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Factors Affec<ng CPAP Adherence
• Snoring history. • Apnea / hypopnea index ( > 30). • Epworth sleepiness score ( > 10).
Prospective evaluation of CPAP use (n = 1,211)
Adherence at 5 yrs (68%): 3 month use predictive
AJRCCM 1999 159:1108-‐14
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CPAP is not op<mal treatment for some
• Restric<ve to sleep for some pa<ents • Side effects can include sore throat, facial soreness, claustrophobia and disrupted sleep
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Mean Nightly CPAP Use: Consistent vs. Intermittent Users
Sleep 1997 20:278-83
Consistent CPAP Users (n=17)
Intermittent CPAP users (n=15)
Days of Therapy
CPAP Use (hrs)
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Targeted interven<ons using objec<ve measurement can improve adherence
• Increased Adherence to CPAP With a Group Cogni<ve Behavioral Treatment Interven<on: A Randomized Trial (n = 100) • A higher adherence to CPAP therapy was found in the CBT group (2.9 hours
difference) rela<ve to treatment as usual (P < 0.001) at 28 days. • Long-‐term Compliance Rates to CPAP in OSA* A Popula<on-‐Based Study (n =296)
• A popula<on-‐based CPAP program consis<ng of consistent follow-‐up, “troubleshoo<ng,” and regular feedback to both pa<ents and physicians can achieve CPAP compliance rates of > 85% over 6 months (> 3.5 hrs/d).
• Interven<ons to improve compliance in sleep apnea pa<ents previously non-‐compliant with CPAP (n = 204) • A two phase interven<on program, first employing standard interven<ons,
followed by a change to flexible bilevel airway pressure, can achieve improved compliance in pa<ents previously non compliant with CPAP
SLEEP 2007; 30(5):635-640 CHEST 2002; 121:430–435 JCSM 2007; 3:706-12
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An approach to poor compliance with CPAP
Sleep Med Rev 2007 11:195-207
Rhinitis
Leaks Skin lesions Conjunctivitis Noise
Dry Mouth
Lack of Improvement
Involuntary removal asleep
Anxiety / Phobia
Negative social aspects
Thoracic pain, Expiration difficulties, Aerophagia, Cold and pressure sensation
Tooth problems, Sinus problems Ear problems
Review steps 1-4
CBT, Desensitization
Nasal sprays
Mask re-fit
Avoid leaks Humidification Chinstrap FFM
Suboptimal pressure Non-pulmonary sleep disorder
Frequently transient
ENT /OMF
1
2
3
4
5
6
7
8
9
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n = 115 n = 116
CHEST 2001; 120:1923–1929
Prevalence of Insomnia Symptoms in Patients with OSA
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Persistent Sleepiness in OSA treated with CPAP
Sleep Med Rev 2007 11:195-207
Ensure duration of sleep is adequate
Confirm Dx of OSA
Confirm adequate CPAP titration
Data management software: Adherence Control of SDB Leaks Variability*
Exclude co-morbid condition causing EDS: Depression Narcolepsy RLS Poor sleep hygiene
Re-examine treatment goals
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Modafinil as an Adjunc<ve Rx to CPAP
Baseline Week 4
Mea
n Sl
eep
Late
ncy
(min
)
8.6 7.2 7.5 7.4
• Population (n = 177) • Randomized placebo controlled • Intervention => 400 mg Modafinil • Outcome measures ESS CPAP adherence MSLT
AJRCCM 2001 164: 1675-81
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Conclusions
• Obstruc<ve sleep apnea is commonly encountered in the outpa<ent clinic
• It is rela<vely easily diagnosed • It is associated with significant co-‐morbidi<es • Effec<ve treatment is available, but requires chronic disease
management • Input from sleep specialists can be helpful in difficult to treat
cases – Poor adherence posi<ve pressure – Co-‐morbid sleep disorders (i.e. insomnia, restless legs, etc)
– Residual day<me sleepiness
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Focusing the treatment on the primary patient complaint
Obstructive Sleep Apnea / Hypopnea
Trial of positive Pressure
Primary concern: snoring
Primary concern: Vascular risk
Primary concern: Daytime Sleepiness
Intolerant of Positive Pressure
Clin Chest Med 2003 24:307–313
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The Future: P4 Medicine
Gene<cs, Genomics, & Proteomics
ü Predic<ve ü Personalized ü Preventa<ve ü Par<cipatory
Systems Biology
Modern Compu<ng Technology
Molecular Oncology 2009 3(1):9-‐17
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NATURE 2010 463: 258-259
Thank You
University of Pi.sburgh / CTSI / Clinical + Transla<onal Science Ins<tute
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PAP Adherence: Benefit of Specialty Care
Pearson χ2 p= 0.01
Using PAP
D/C’ed PAP
MD + Center + (n=307)
95% 5%
MD or Center + (n=99)
93% 7%
MD – Center – (n=38)
79% 21%
• Factors associated with discon<nua<on • Lack of MD cer<fica<on or center accredita<on*
• Nasal conges<on severity
• Factors associated with con<nua<on • Pa<ent educa<on of health risk of OSA
JCSM 2006 2:133-‐142 MD + = Cer<fied in Sleep Medicine Center + = Accredited AASM Center
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CHEST 2012; 141(1):51–57
Conclusions: A be?er understanding of predictors of CPAP adherence may be useful in idenKfying paKents who may benefit from a sleep specialist consultaKon prior to ordering a diagnosKc PSG.
Results: A sleep specialist consultaKon prior to the diagnosKc PSG was associated with 58.2 min more per day ( P = .002)
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Fully adjusted OR: Diagnos<c group OR (95% CI) Snoring Untreated Mild-‐moderate OSA Untreated severe OSA CPAP
1.03 (0.31 -‐ 1.84) 1.15 (0.34 -‐ 2.69)
2.87 (1.17 -‐ 7.51)
1.05 (0.39 -‐ 2.21) Model adjusted for age, diagnos<c group, presence of cardiovascular disease,
hypertension, diabetes, lipid disorders, smoking status, alcohol use, systolic and diastolic blood pressure, blood glucose, total cholesterol, triglycerides, and current use of an<hypertensive, lipid-‐lowering, and an<diabe<c drugs. Variables included in the part adjusted model were those included in the fully adjusted model except hypertension and presence of cardiovascular disease
Marin JM, et al. Lancet 2005; 365: 1046.
OSA is only associated with CVD in those with severe OSA
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• BestAIR: Best Apnea Interven<ons In Research – Prepares for Phase 3 study
• Sham vs CMT as control arms • CBT-‐guided CPAP adherence vs RT-‐guided adherence • Control vs Ac<ve PAP – 24 BP, cardiac func<on, biomarkers
• ABC: Apnea, Bariatric Surgery, and CPAP Trial – Bariatric surgery as a first line treatment (vs CPAP)
• COMET: Compara<ve Effec<veness CPAP Management
– Oral Appliances vs CPAP in women with OSA
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♣ Aim: Demonstrate that MV ASV therapy over minimum two years can improve morbidity and mortality in patients with predominant central sleep apnea and heart
failure (HF) ♣ Design: randomized controlled trial with >1300 evaluable subjects
- Control arm: optimal medical care - Active arm: optimal medical care plus ASV ♣ Status: Enrolment completed in May 2013
♣ Progress: Currently enrolled over 1300 patients in 78 centers ♣ Main sub-study: Demonstrate that MV ASV therapy improves heart failure outcomes such
as left ventricular ejection fraction and quality of life metrics (n=300)
♣ CAT-HF: Cardiovascular improvements with MV ASV therapy in HF ♣ Randomized controlled trial of acute decompensated HF followed for 6 months ♣ n = 200 hospitalized HFrEF and HFpEF with SDB (OSA or CSA) ♣ Endpoint: Primary - survival free from CV hospitalization and improvement in 6MWD ♣ Goal: Incorporation of MV ASV therapy into the ACC/AHA HF guidelines with
SERVE-HF ♣ Randomized controlled study of MV ASV in patients with HF - The confirmatory trial of
efficacy on cardiac function SAVIOR
♣ Scheduled completion Fall 2014 ♣ Study jointly undertaken with our Japanese distributor ♣ Retrospective and prospective components ♣ n = 300* HF “All-comers”