slides - slide 1

53
University of Pennsylvania School of Nursing Strategies for Promoting Continuous Positive Airway Pressure (CPAP) Use in the Treatment of Obstructive Sleep Apnea Terri E. Weaver, PhD, RN, FAAN Ellen and Robert Kapito Professor in Nursing Science Chair, Division of Biobehavioral and Health Sciences School of Nursing Division of Sleep Medicine and Center for Sleep and Respiratory Neurobiology, Department of Medicine School of Medicine University of Pennsylvania [email protected]

Upload: medresearch

Post on 12-Jun-2015

614 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: slides - Slide 1

University of Pennsylvania School of Nursing

Strategies for Promoting Continuous Positive Airway Pressure (CPAP) Use in the

Treatment of Obstructive Sleep Apnea

Terri E. Weaver, PhD, RN, FAANEllen and Robert Kapito Professor in Nursing ScienceChair, Division of Biobehavioral and Health Sciences

School of NursingDivision of Sleep Medicine and

Center for Sleep and Respiratory Neurobiology,Department of Medicine

School of MedicineUniversity of [email protected]

© Weaver, 2009

Page 2: slides - Slide 1

Disclosures Research Grants: Protech; Respironics, Inc.;

Respironics Sleep and Respiratory Research Foundation; Cehpalon, Inc.

Consultant: Apnex Medical, Cephalon, Inc.

FOSQ License Agreements: Sanofi-Aventis Pharmaceutical, Merck & Co., Inc., Sleep Solutions, N.V. Organon, Aspire Medical, Inc., Apnex Medical, Ventus Medical, GlaxoSmithKline, Philips Respironics, Inc., Cephalon, Inc.

Page 3: slides - Slide 1

Objectives

To define optimal adherence to CPAP treatment

To describe the nature of CPAP useTo discuss the “myths” regarding why

patients don’t adhere to treatmentTo present strategies to enhance CPAP use

Page 4: slides - Slide 1

CPAP Acts as an Airway Stent

Courtesy Dr. Richard Schwab

CPAP Settings

0 cm H20

5 cm H20

10 cm H20

15 cm H20

Page 5: slides - Slide 1

CPAP is an effective treatment

Clinical trials have shown that in severe OSA (RDI>30) CPAP improves excessive daytime sleepiness and to some degree functional status

Limited research on effect of CPAP in mild (RDI=5-15) or moderate (RDI=16-30) disease, especially randomized controlled trials

Representing 15% US population, unclear whether CPAP treatment improves functional status, excessive daytime sleepiness and mood in those with milder OSA

AHISleep

ArchitectureSubjective Sleepiness

Objective Sleepiness

Neuro-cognitiveand Mood

Quality of Life

Cardiovascular Risk Reduction

SevereOSAS + +/- + +/- +/- +/- +/-Mild/

ModerateOSAS

+ +/- +/- - +/- +/- +/-

Courtesy of Dr. Neil Freedman Gay, P et al. SLEEP 2006;29:381- 401

Page 6: slides - Slide 1

What should be the nightly duration or dose?

Page 7: slides - Slide 1

Nightly Duration of CPAP Determines Improvement in Daytime Sleepiness

Stradling & Davies, SLEEP, 2000

Page 8: slides - Slide 1

Impact of CPAP on Neurobehavior

5.21 h

3.42 h

Zimmerman et al., Chest, 2006

P = 0.02N = 58

Page 9: slides - Slide 1

< = 2 >2 - <4 < = 4 - <5 > = 5 - <6 > = 6 - <7 > =70

0.1

0.2

0.3

0.4

0.5

0.6

0.7

Hours CPAP Use to Obtain Normal Values

ESS (n = 137)

MSLT (n = 136)

FOSQ (n = 147)

Hours CPAP Use

% P

ati

en

ts w

ith

No

rma

l V

alu

es

Weaver, et al. Sleep 2007

Proportion of Subject with Normal Response Relative to Nightly CPAP Use

Page 10: slides - Slide 1

Functional Outcomes of Sleep Questionnaire

30-item disease-specific functional status measure for disorders of daytime sleepiness

How difficult is it for you to (task)...because you are sleepy or tired?

5 subscales (score range 1 - 4) alpha = 0.86- 0.91

General Productivity Vigilance

Activity Level Social Outcome

Intimacy and Sexual Relationships• Test-retest reliability: Total score r = 0.90, Subscales r = 0.81

- 0.90 Translated into 51 languages; used in studies worldwide

Weaver et al., SLEEP, 1997

Page 11: slides - Slide 1

FOSQ-10 Development10 questions length decided a priori 5th grade reading levelQuestions from each of original FOSQ

subscales– General Productivity (2)– Activity Level (3)– Vigilance (3)– Social Outcomes (1)– Intimate and Sexual Relationships (1)

Effect sizes of selected questions range from 0.39 to 1.07

Chasens, et al., SLEEP, 2009

Page 12: slides - Slide 1

< = 2 >2 - <4 < = 4 - <5 > = 5 - <6 > = 6 - <7 > =70

0.1

0.2

0.3

0.4

0.5

0.6

0.7

Hours CPAP Use to Obtain Normal Values

ESS (n = 137)

MSLT (n = 136)

FOSQ (n = 147)

Hours CPAP Use

% P

ati

en

ts w

ith

No

rma

l V

alu

es

Weaver, et al. Sleep 2007

Proportion of Subject with Normal Response Relative to Nightly CPAP Use

Page 13: slides - Slide 1

Self-report unreliable

Use across studies averages ~ 5 hrs/night

29-83% reported to be nonadherent

Half the patients are consistent users averaging ~ 6 hrs/night

Weaver & Grunstein, PATS, 2007; Kribbs et al., Am J Resp Crit Care Med; 1993; Weaver et al., Sleep, 1997; Rosenthal et al., Sleep Med, 2000, Stradling & Davies, Sleep, 2000; Campos-Rodriguez et al., Chest, 2005; Lindberg et al., Sleep Med, 2006

6.21 + 1.21

3.45 + 1.94

What do we know about adherence?

Page 14: slides - Slide 1

2

3

4

5

6

7

8

1 2 3 4 5 6 7 8 9

Days of Therapy

Mea

n N

igh

tly

CP

AP

Use

(H

rs)

Intermittent Users

Consistent Users

Series10

10

20

30

40

50

60

70

80

90

> 4h/night < 4h/night

% U

sin

g C

PA

P >

4h

/nig

ht

at D

ay 3

0

CPAP Use on Day 3

No Difference in 10 Yrs – Pattern of Adherence Established Early

Budhiraja, Sleep, 2007Weaver et al., Sleep, 1997

Courtesy of Neil Freedman, MD

Page 15: slides - Slide 1

Is CPAP Adherence a Problem?

An Australian patient was recently informed that he had OSA. He was advised to use CPAP.

He took one look at it and said: “I’ll buy one and put it on my refrigerator so I will stop

eating!”

Courtesy R. Grunstein

Page 16: slides - Slide 1

Myth #1It’s disease severity!

Pre

dic

ted

Pro

ba

bil

ity

of

ES

S<

11

p = > 0.05

Weaver, et al., Sleep, 2007

False!

Page 17: slides - Slide 1

Myth #2It’s the split-night study!

Page 18: slides - Slide 1

The Titration Experience• Split night vs. full night – no

difference in adherence• Attended PSG vs. unattended

(home) PSG– Attended PSG - longer avg. use per

night (5.0 hours vs. 3.9 hours)– Wore CPAP on more nights (76.5%

vs 64.2%) Means et al, Sleep and Breathing, 2004

• “Have you encountered any problems during this first night of CPAP?’’ Yes – 3X more likely to use CPAP < 4h

• Lewis et al, SLEEP, 2004

• Sample (n = 71) mean 5.04 ± 2.59 h/night

• Best predictor - Δ in SE from diagnostic to titration PSG

p < 001 (r = .48) Drake et al., SLEEP, 2003

Δ 2.03 h/night

Page 19: slides - Slide 1

Myth #3It’s the mask!

Page 20: slides - Slide 1

Adherence and Technological Interface

Adherence higher with mask vs. nasal pillow, or full face mask

Fewer adverse effects, less sleep difficulty and air leak occurred with nasal pillows Massie et al., Chest, 2003

No difference in adherence between oral interface and nasal mask

Anderson et al., Sleep, 2003; Khanna & Kline, Sleep Med, 2003; Beecroft et al., Chest, 2003

No conclusive evidence supporting technology interface or level of pressure

37% report mask related side effects, Those reporting mask effects had higher use

Weaver et al., SLEEP, 1997; Drake et al, SLEEP, 2003

Page 21: slides - Slide 1

Oracle CPAP Mask 66% chose typical mask-less invasive, less feeling

claustrophobic, less choking or gagging 27% chose Oracle mask - lack of head gear, mouth

breathers, get more air, more comfortable 7% oronasal mask- mouth breathers, didn’t like

Oracle mask

Beecroft CHEST, 2003

Page 22: slides - Slide 1

• Higher claustrophobia scores twice likely poor adherence (mean CPAP use < 2 hours per night)

• Claustrophobia scores decreased over time in some

15% scores > 25

Chasens et al., Western J Nurs Res, 2005

Page 23: slides - Slide 1

Does the Nose Make a Difference? Nasal Area and CPAP Use

Li, H.Y., et al., SLEEP, 2005 Morris et al., Am J Rhinology, 2006

Page 24: slides - Slide 1

Myth #4It’s the pressure!

Page 25: slides - Slide 1

Auto-Titrating vs. Fixed Mode

• Pressure not issue• Less trouble getting to

sleep• Better quality sleep• Less pressure

discomfort with auto-titrating device

• Better quality of life– Vitality, Mental Health

• Adherence findings not consistent

0

50

100

150

200

250

300

350

Min/24 hr % nights

Auto-Titrating

Fixed Mode

Massie et al., Am J Respir Crit Care Med, 2003

*

0

2

4

6

8

10

12

Med Pressure Residual AHI

Auto-Titrating

Fixed Mode

*

*

* P<0.05

*

*

Page 26: slides - Slide 1

C-Flex Adjusts Pressure Relief Based on Expiratory Flow

• C-Flex provides expiratory pressure relief, determined by:- Expiratory flow

- Patient adjustable, C-Flex setting (1, 2, or 3)• Pressure relief is proportional to flow (i.e. more exhalation effort equals more

relief)• Returns to baseline pressure before inhalation

I

E

Courtesy Dr. Neil Freedman

Page 27: slides - Slide 1

Flexible Pressure vs. CPAP

Wk 2 – 4 – Flexible Pressure 4.2 ± 2.4

hrs vs. – CPAP 3.5.± 2.8 hrs

Wk 9 – 12– Flexible pressure 4.8 ±

2.4hrs vs.– CPAP 3.1.± 2.8 hrs

Main Effect for Group

(p<.01)– 4.8(C-Flex) vs. 3.5 (CPAP)

Self-Efficacy improved both groups and related to adherence – No difference between groups

Aloia et al, Chest, 2005

CPAP Group (n 41) and the C-Flex Group (n 48)

Page 28: slides - Slide 1

Current CFlex Conclusions:C-Flex = CPAP

0

1

2

3

4

5

6

7

8

CPAP PRCPAP

• Equal improvements in Epworth Sleepiness Scale

• Equal reductions in AHI• Similar pressures• No benefits in higher

pressure patients (CPAP > 9 cm H2O)

Nilius, G et al. Chest 2006

Mea

n H

ours

/Nig

ht

Equal Compliance

Courtesy Dr. Neil Freedman

Page 29: slides - Slide 1

Novel Bilevel Pressure Systems(BiFLEX)

Courtesy Dr. Neil Freedman

Page 30: slides - Slide 1

Novel Bilevel Pressure Systems(BiFLEX)

• No Advantage in Initial Treatment vs CPAP

• May Improve Compliance in CPAP Non-Compliant

Gay, et al. Sleep 2003

0

1

2

3

4

5

6

7

8

CPAP BiFlex

Com

plia

nce

(Hou

rs/D

ay)

Ballard et al. J Clinical Sleep Med 2007

0

20

40

60

80

100

% U

sin

g T

her

apy

> 4

hrs

/Day

CPAP BiFLex

* P = 0.03

*

Page 31: slides - Slide 1

Humidification – Conflicting data Warm humidification better use Placebo controlled trial no benefit on initial titration Routine application of humidification no better for

reducing side effects than “as needed” basis

The addition of heated humidification is indicated to improve CPAP utilization (Standard)

Massie et al., Chest, 1999; Neill et al, Eur Resp J, 2003; Duong et al., Eur Respir J, 2005; Mador et al., Chest, 2005

Page 32: slides - Slide 1

Myth #4 It’s a psychological disorder

Not supported by literature:

• Depression• Anxiety• Stress• Social desirability

Supported by literature:• Patient’s idea to seek tx• Active but not passive coping

– Confrontive coping– Planful problem solving

• Outcome expectancies and self-efficacy plus knowledge and social support

• Maladaptive behaviors– Emotional reactions– Social isolation

Hoy et al., Am J Resp Crit Care Med, 1999; Stepnowsky et al, Sleep, 2002; Stepnowsky et al, Sleep Med, 2002, Aloia et al, J Clin Sleep Med, 2005; Wells et al., Psychsom Med, 2007; Lewis et al., SLEEP, 2004; Poulet et al., 2009

Page 33: slides - Slide 1

Cognitions Related to CPAP:Perceived Risk

N = 213

Perceived Risks

Percentage perceived OSA as risk for negative outcomes

Responding High or Very High Falling asleep during day 72% Having high blood pressure 64% Having heart attack 59% Difficulty concentrating 54% Falling asleep driving 52% Being depressed 49% Having an accident 46% Having problem with sexual desire or performance

38%

Weaver et al., SLEEP, 2003

Page 34: slides - Slide 1

Cognitions Related to CPAP:Perceived Benefit

CPAP Outcome Expectancies

Percentage perceived CPAP would produce positive outcomes

Responding Somewhat True or Very True I will feel better 92% I will not snore 85% I will be more active 85% Bed partner will sleep better 77% Improve job performance 76% Decrease chance of driving accident

71%

Improve relationships 67% Be more alert 66% Improve desire and sexual performance

53%

Weaver et al., SLEEP, 2003

Page 35: slides - Slide 1

Cognitions Related to CPAP: Perceived Self-Efficacy

CPAP Self-Efficacy I would use CPAP even if...

Percentage perceived could wear CPAP even if confronted with

obstacles Responding Somewhat True or Very

True Took longer to get ready for bed

85%

I traveled 77% Feel embarrassed 75% Had to wear tight mask 68% It were a bother 68% Had to pay for some of cost 63% It made my nose stuffy 58% Made me feel claustrophobic 49% Disturbed my bed partner’s sleep

48%

Weaver et al., Sleep, 2003

Decreased use in Week 1 if affected sexual relations

Page 36: slides - Slide 1

What Patients SayNonadherent participants had negative

experiences during initial exposureFew experienced benefits, unsuccessful or

absence of problem-solving efforts – influenced perceived ability to use CPAP over the long-term

When CPAP identified as important – applied “tricks and techniques” to successfully use CPAP

Sawyer, et al., J Qual Res, in press

Page 37: slides - Slide 1

Adherence to Medication

• Patients treated with CPAP not more adherent than those who do not use CPAP

• Nonadherence to CPAP not an indictor of nonadherent behavior

• Females and those with

co-morbidies most adherent

Villar, SLEEP, 2009

Page 38: slides - Slide 1

- 365

MedicationAdherence (Exposure)

Initial CPAP Adherence (Outcome)

(7 days)365 Days

Gap

Simvastatin 20 mg/day

90 8060 9045

% Refill Adherence = 78%

0

1111111111111111111111111000000000011111

Lipid Lowering Medication Adherence

Initiation of CPAP for OSA

Platt et al., SLEEP, in press

Page 39: slides - Slide 1

70% (IQR 48-81)

% Refill for lipid-lowering therapy

Adjustedprobability

of CPAP use ≥ 4 h/day*

99% (IQR 96-100)(n=60) (n=57)

“Low” “High”

* Adjusted for age, race, AHI, Epworth Sleepiness Scale,

BMI, Charlson Index, first day of

use

Probability of Adequate CPAP Adherence by Medication Adherence Subgroup

0.8

0.6

0.4

0.2

0

Platt et al., SLEEP, in press

Page 40: slides - Slide 1

Association Adherence & Socioeconomic Status

Retrospective analysis of VA patients with AHI >5 N=266

Census block group-level data from 2000 census data were matched to 9-digit zip

Median CPAP use equaled 3.9 h Participants in neighborhoods with

higher socioeconomic status had substantially higher odds of adhering to CPAP treatment

Adjusted odds ratio [OR] = 1.4 for each SD increase in SE status index [95% CI, 1.2–1.7, P < 0.001])

Page 41: slides - Slide 1

How to Improve AdherenceWhat Didn’t Work

• Telephone calls alone• Education, telephone support, and

early review of CPAP use did not make a difference

• Auto-CPAP• Bilevel

Likar et al., Chest, 1997; Chervin et al., Sleep, 1997; Haniffa et al., Cochrane Review, 2005; Fitzpatrick et al., Am Rev Respir Dis, 2003; Fletcher & Luckett,. Am Rev Respir Dis, 1991; Massie et al., Am J Resp Crit Care Med, 2003; Jean Wiese, Sleep Med, 2005; Hoy et al., Am J Resp Crit Care Med, 1999; Hui et al., Chest, 2000; DeMolles et al., Med Care, 2004

Page 42: slides - Slide 1

How to Improve AdherenceWhat Did Work

Education • Video presentation

Provider contact• Computer-based follow-up• Bed partner?

Self-titration Flexible pressure ? Intensive support education that included the spouse

• 3 nights of CPAP titration in the laboratory• Multiple home visits over 1 month

Cognitive behavioral therapyLikar et al., Chest, 1997; Chervin et al., Sleep, 1997; Haniffa et al., Cochrane Review, 2005; Fitzpatrick et al., Am Rev Respir Dis, 2003; Fletcher & Luckett,. Am Rev Respir Dis, 1991; Massie et al., Am J Resp Crit Care Med, 2003; Jean Wiese, Sleep Med, 2005; Hoy et al., Am J Resp Crit Care Med, 1999; Hui et al., Chest, 2000; DeMolles et al., Med Care, 2004; Richards, D., et al., Sleep, 2007, Ballard et al., JCSM, 2007

Page 43: slides - Slide 1

Change in Adherence After Behavioral Intervention

0

2

4

6

8

Hours/night

Experimental 5.2 6.3 7.8

Control 5.2 5 4.6

Week 1 Week 4 Week 12

Controls; Same contact - No OSA or CPAP information

Session 1: Review symptoms Review PSG with CPAP Discuss advantages/

disadvantages of treatmentSession 2: Examine compliance data first

wk Discuss changes with

treatment Troubleshoot discomfort Discuss realistic expectations

of treatment Review treatment goals

* P< 0.04

Aloia et al, Sleep and Breathing, 2001

**

Page 44: slides - Slide 1

After 28 days CPAP use: (p<0.05)

• More usual therapy did not take machine home

• Mean nightly use 5.38 (CBT) vs. 2.51 h/night

• CBT higher proportion using CPAP > 4h/night 50% vs. 15%

• Greater self-efficacy• Higher scores for social

support

Richards et al.,SLEEP, 2007

• Randomized trial n=48/group• Usual treatment – masking

fitting, information• Group CBT (10/group with

partners) – 2, 1h sessions– Slide presentation and booklet

on normal sleep, health consequences of OSA, effectiveness of CPAP treatment

– CPAP machine on display, handled, but did not wear mask

– Relaxation techniques

Page 45: slides - Slide 1

Should medications be used to promote CPAP use?

Page 46: slides - Slide 1

Randomly assigned patients to receive eszopiclone, 3 mg (n = 80) or matching placebo (n = 80) for first 2 wks treatment

6 months CPAP use*:• Eszopiclone = 64.4% nights, 3.57 h • Placebo = 45.2%, 2.42h

*p<0.05

Lettieri, Ann Intern Med 2009

Page 47: slides - Slide 1

Residual Sleepiness

Copyright Cephalon, Inc, 2007;Weaver et al., Sleep, 2007

Nightly CPAP Use > 6 h

Page 48: slides - Slide 1

0.0

2.5

5.0

7.5

10.0

12.5

15.0

Baseline Latency Sleep Loss Latency

Mea

n S

leep

Lat

ency

(M

inut

es)

Sleep latency remains low and there is a 40% loss of Dopamine & Norepinephrine wake neurons after 8 wk * p < .05

Zhu , et al. J Neurosci. 2007Zhu , et al. J Neurosci. 2007

Irreversible Sleepiness and Wake Neuron Damage in a Murine Model of Sleep Apnea Oxygenation

*

*

**

= control

= hypoxic

TH = Tyrosine Hyrdoxylase Positive Cleaved PARP, a biproduct of caspase-3

Locus Ceruleus

Page 49: slides - Slide 1

Changes in Brain2

• Proinflammatory activation

• Reduced extracellular dopamine levels

• Increased oxidative stress

• Apoptosis• Gliosis

Cortical sections - GFAP-IR1

Control rats - A , CIntermittent hypoxemia - B, D

GFAP-IR = glial fibrillary acidic protein immunoreactivity.

GFAP-IR = glial fibrillary acidic protein immunoreactivity.

Effects of Intermittent Hypoxemia

1. Gozal D, et al. J Neurosci 2001;21:2442-2450. 2. Santamaria J, et al. Sleep Med Rev 2004;11:195-207

Page 50: slides - Slide 1

Efficacy of Modafinil for Residual Sleepiness in Patients with OSA on CPAP Treatment

Daytime Sleepiness

N =

* *

Baseline Week 1 Week 40

4

8

12

16

ES

S S

core

**

Baseline Week 40

2

4

6

8

10

Sle

ep

La

ten

cy (

Min

ute

s)

CPAP + Placebo CPAP + Modafinil

Pack AI, et al. Am J Respir Crit Care Med 2001

* *

**

* P<.001, ** P = .021 for change from baseline vs. CPAP + Placebo

Page 51: slides - Slide 1

Mean CPAP use = 6.2 hours* P < .05 for mean change from baseline vs. CPAP + PlaceboMean CPAP use = 6.2 hours* P < .05 for mean change from baseline vs. CPAP + Placebo

Efficacy of Modafinil for Residual Sleepiness in Patients with OSA on CPAP Treatment

Functional Quality of Life

Activity Level Vigilance

* * * *

Baseline Week 4 Baseline Week 41

2

3

4

Activity Level andVigilance Subscales

CPAP + Placebo (n = 80)

CPAP + Modafinil (n = 77)

Baseline Week 1 Week 45

10

15

20

FOSQ Total Score

CPAP + Placebo (n = 80)

CPAP + Modafinil (n = 77)

Dinges DF, Weaver TE. Sleep Med 2003

* ** *

Page 52: slides - Slide 1

Putting It All Together – Critical ElementsPre- Treatment1. Who referred patient?2. Knowledge of

OSA/Perception of treatment3. Degree & awareness

symptoms4. How do they handle

challenges?5. Assess claustrophobic

tendencies6. Consult otorhinolaryngologist7. Mask selection8. Exposure to treatment9. Spousal involvement

On-Treatment1. Humidification, if

needed2. Phone call/Follow-up

1st wk3. Assessment of use and

outcome4. Perception of

treatment5. Bed partner experience6. Troubleshoot problems

immediately7. Treat residual

sleepiness

Page 53: slides - Slide 1

Thank you!

MerciDankeGrazie

GraciasDank u

Σας ευχαριστούμε

Вы

Obrigado

Tacka dig

谢谢θæŋk

ありがとう أنت شكرت고맙습니다