SLEEP 2011 Abstract Supplement

B. Clinical Sleep Science I. Sleep Disorders – Breathing
0422
CLINICAL EFFICACY OF A NASAL EXPIRATORY POSITIVE
AIRWAY PRESSURE (EPAP) DEVICE FOR THE TREATMENT
OF OBSTRUCTIVE SLEEP APNEA
Massie C, Hart RW
Chicago Sleep Group, Elk Grove Village, IL, USA
Introduction: PROVENT® Therapy (Ventus Medical Inc.) is a novel
and effective nasal EPAP treatment for patients with OSA. It is well
tolerated, easy to use and less cumbersome than traditional therapies.
Methods: Eligible patients in this community based sample had OSA
and were treatment naive, or they had tried and failed CPAP. A total of
123 patients were offered nasal EPAP. Polysomnography was recommended
if patients intended to use nasal EPAP as a primary treatment,
OSA severity was moderate to severe, or OSA severity was mild and
accompanied by medical co-morbidities.
Results: Of the 123 patients offered nasal EPAP, 64% were CPAP failures,
32% were treatment naive and 4% had tried therapies other than
CPAP. There were no differences in age (51 yrs ± 10), gender (72% men)
or BMI (32 ± 6) between the entire sample and those patients with PSG
data. Follow-up is pending for 53 patients. In the analysis of the remaining
70 patients, 41 (59%) accepted therapy after an initial trial. Eleven
are continuing with nasal EPAP therapy based on physician evaluation
and subjective symptom relief. Polysomnographic data were available
for 30 patients. Treatment success was defined as a reduction in AHI ≥
50% or an AHI < 10. Twenty four patients (80%) were effectively treated.
The median AHI was reduced from 17.1 to 4.9 (p < .0001). There
was a trend toward lower mean Epworth scores [7.2 to 5.5 (p=0.07)].
Conclusion: Nasal EPAP is an effective and well tolerated initial treatment
option for patients with mild to moderate OSA or for patients who
cannot tolerate CPAP.
Support (If Any): This study was supported in part by Ventus Medical
Inc.
0423
NASAL EPAP THERAPY FOR SLEEP APNEA: ESTIMATION
OF TREATMENT RESPONSE
Schweitzer PK 1 , Colrain IM 2,3 , Rosenthal L 4 , Berry RB 5 , Rapoport DM 6 ,
Walsh JK 1,7
1
Sleep Medicine and Research Center, St Luke’s Hospital, Chesterfield,
MO, USA, 2 Human Sleep Research Program, SRI International,
Menlo Park, CA, USA, 3 Department of Psychology, The University of
Melbourne, Parkville, VIC, Australia, 4 Sleep Medicine Associates of
Texas, Dallas, TX, USA, 5 Division of Pulmonary, Critical Care, and
Sleep Medicine, University of Florida, Gainesville, FL, USA, 6 Division
of Pulmonary, Critical Care, and Sleep Medicine, NYU School of
Medicine, New York, NY, USA, 7 Department of Psychology, Saint
Louis University, St. Louis, MO, USA
Introduction: Studies of a novel EPAP device (PROVENT, Ventus
Medical) have shown improved sleep disordered breathing in OSA patients
overall but the number of patients with meaningful treatment response
is unclear. The current analysis was undertaken to better estimate
the proportion of patients meeting a standard definition of treatment
response and to investigate predictors of response across five studies.
Methods: Data from studies involving 199 subjects with AHI > 5
(AASM scoring) or > 10 (Chicago scoring) who had 1 baseline and 1-3
EPAP PSGs were evaluated. Treatment response was defined as a decrease
in AHI ≥ 50% and AHI < 10 (AASM scoring) or < 20 (Chicago
scoring).
Results: EPAP decreased AHI (29.9 ± 24.9 to 16.9 ± 21.0), percent stage
N1 (24.0 ± 16.4 to 21.6 ± 15.1), and arousal index (26.5 ± 24.3 to 19.3
± 21.0; P < .007 for all). Forty-seven percent met treatment response
criteria (Responders) and an additional 11% showed a decrease in AHI
≥ 50%. Mean AHI with EPAP was 4.7 ± 3.3 for Responders and 27.8 ±
24.0 for all others. At baseline, Responders had lower AHI (21.3 ± 12.4
vs 37.6 ± 30.3, P < .001) and BMI (31.7 ± 6.4 vs 33.6 ± 6.4, P = .03)
and a trend for a higher REM/nonREM AHI ratio (4.1 ± 10.4 vs 2.2 ±
3.0, P = .07). Responders did not differ from other subjects in sex, age,
neck size, Mallampati rating, CPAP pressure requirements, or baseline
Epworth, FOSQ, or supine/non-supine AHI ratio. Regression analysis
found that AHI was the only significant predictor of treatment response.
Responders comprised 54% of subjects with mild, 68% with moderate,
and 25% with severe OSA.
Conclusion: EPAP produced a meaningful treatment response in 47%
of OSA patients and decreased AHI at least 50% in an additional 11%.
Lower baseline AHI was associated with a positive treatment response.
0424
RETROSPECTIVE CASE SERIES ANALYSIS OF A NASAL
EXPIRATORY POSITIVE AIRWAY PRESSURE (EPAP)
DEVICE TO TREAT OBSTRUCTIVE SLEEP APNEA IN A
CLINICAL PRACTICE
Adams G 1,2,3
1
Sleep, Pulmonary, Critical Care Medicine, Sleep Medicine Specialists,
PLLC, Sarasota, FL, USA, 2 Medical Director, Sleep Disorders Center,
Sarasota Memorial Hospital, Sarasota, FL, USA, 3 Clinical Assistant
Professor, Florida State University Medical School, Sarasota, FL, USA
Introduction: Continuous positive airway pressure (CPAP) is considered
the gold standard treatment for patients with obstructive sleep apnea
(OSA). However, other treatment alternatives for OSA are needed
to provide increased compliance and additional choices for patients and
prescribing physicians. Prior studies have reported that a nasal expiratory
positive airway pressure (EPAP) device (PROVENT® Therapy,
Ventus Medical, Inc) significantly reduced the apnea-hypopnea index
(AHI) as well as improved oxygenation and subjective daytime sleepiness.
This retrospective analysis was conducted to evaluate real-world
patient acceptance and outcomes of this new therapeutic option in a
clinical setting.
Methods: Patients with a diagnosis of obstructive sleep apnea (AHI
> 10/hour) were approached to try nasal EPAP. 97% of the patients
were either CPAP failures or current CPAP users. Patients received 10
nights of sample devices for in-home acclimation evaluation. Patients
that acclimated were asked to return for efficacy confirmation using
standard in-lab polysomnography (PSG). During the PSGs, adjunctive
therapy (e.g. chin straps, positional therapy) was used, when necessary,
to achieve optimal efficacy. Patients with demonstrated efficacy were
given a prescription for nasal EPAP.
Results: At a single center, 151 patients sampled nasal EPAP and 131
are in the analysis group (16 patients pending follow up and 4 status
unknown). Of the analysis group, 98 patients (75%) acclimated to the
device. Effectiveness (AHI < 10) was achieved in 80.7% of all patients
and 90.6% of mild/moderate OSA patients. AHI was reduced to < 5 in
56.3% of all patients (63.9% of mild/moderate OSA patients). The median
AHI was reduced from 25.8 to 4.2 (p