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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
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.
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
CPAP Acts as an Airway Stent
Courtesy Dr. Richard Schwab
CPAP Settings
0 cm H20
5 cm H20
10 cm H20
15 cm H20
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
What should be the nightly duration or dose?
Nightly Duration of CPAP Determines Improvement in Daytime Sleepiness
Stradling & Davies, SLEEP, 2000
Impact of CPAP on Neurobehavior
5.21 h
3.42 h
Zimmerman et al., Chest, 2006
P = 0.02N = 58
< = 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
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
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
< = 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
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?
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
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
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!
Myth #2It’s the split-night study!
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
Myth #3It’s the mask!
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
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
• 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
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
Myth #4It’s the pressure!
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
*
*
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
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)
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
Novel Bilevel Pressure Systems(BiFLEX)
Courtesy Dr. Neil Freedman
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
*
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
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
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
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
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
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
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
- 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
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
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])
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
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
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
**
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
Should medications be used to promote CPAP use?
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
Residual Sleepiness
Copyright Cephalon, Inc, 2007;Weaver et al., Sleep, 2007
Nightly CPAP Use > 6 h
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
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
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
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
* ** *
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
Thank you!
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