Oral Pressure Therapy Improves ObstrucIve Sleep Apnea Atul Malhotra, M.D.1, Richard K. Bogan, M.D.2, Mehran Farid‐Moayer, M.D.3, Philip M. Becker, M.D.4, Rochelle Goldberg, M.D.5, D. Alan Lankford, Ph.D.6, Lawrence C. Siegel, M.D.7,8, Jed Black, M.D.8, Andrew Goldberg, M.D.9, Ian M. Colrain, Ph.D.10,* 1Brigham and Women’s Hospital, Boston, MA 2SleepMed of South Carolina, Columbia, SC, 3Peninsula Sleep Center, Burlingame, CA, 4Sleep Medicine Associates of Texas, Dallas, TX, 5Sleep HealthCenters, Phoenix, AZ, 6Sleep Disorders Center of Georgia, Atlanta, GA, 7ApniCure, Redwood City, CA, 8Stanford University, Stanford, CA, 9University of California, San Francisco, CA, 10SRI InternaUonal, Menlo Park, CA, *study PI METHODS ABSTRACT RATIONALE: No treatment for obstructive sleep apnea (OSA) is completely effective and fully tolerated. This study examined the
safety, effectiveness, and tolerability of a novel non-invasive oral pressure therapy (OPT) system (Winx, ApniCure, Inc.) designed to
reduce airway obstruction. The system is comprised of a bedside console, a soft polymer mouthpiece, and a flexible tube connecting
the mouthpiece to the console. The console contains a pump that creates vacuum pulling the soft palate anteriorly and stabilizing
the tongue to reduce obstruction during sleep.
METHODS: Thirty consecutively enrolled subjects (22 men), BMI 32.1±3.8 kg/m2 (mean±SD), 53.3±8.2 years (range 37-71), with mild
moderate, or severe OSA underwent laboratory polysomonography at baseline (one night with (Tx1) and one without treatment in
randomized order) and again following 28 nights of treatment (Tx28). Apnea-hypopnea index (AHI, /hr) was calculated using
American Academy of Sleep Medicine criteria by a blinded scorer. Symptomatic response was assessed using Epworth Sleepiness Scale
(ESS) and a modified Functional Outcomes of Sleep Questionnaire (mFOSQ). Mouthpiece usage was assessed automatically by the
console (hours turned on and oral pressure). Statistical analysis was based on differences between control and treatment nights.
RESULTS: Two subjects withdrew before completion of 28 nights of treatment due to oral tissue discomfort and irritation. There
were no serious or severe adverse events. AHI was significantly reduced in the whole group. (Table 1) Clinical success defined a priori
as AHI reduction ≥ 50% and treatment AHI ≤ 20 was observed in 14/30 subjects (3/7 mild, 4/9 moderate, 7/14 severe). In these 14
subjects, AHI was reduced from 31.0 (18.8-45.1) to 5.7 (4.6-9.1) (median (interquartile range)) and for eleven of them, treatment AHI
was < 10. ESS and mFOSQ were maintained in subjects undergoing OSA therapy immediately prior to baseline and improved in those
untreated in the prior two weeks. (Table 1) Subjects completing the 28-night take-home period averaged usage on 94% of nights. The
system was on 6.4±1.0 hours per night and used 6.0±1.0 hours per night. At the conclusion of study participation, 78% of subjects
indicated they would use the system to treat their OSA.
TABLE 1.
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Six centers, Good Clinical Practice
Subjects with mild to severe OSA, with or without prior CPAP use
•  Exclusions: poor nasal patency, OSA surgery history, central sleep apnea, severe
cardiovascular disease, BMI > 40
PSG obtained at baseline (without OSA treatment for at least 2 weeks) and with treatment
(Tx1) in random sequence. PSG repeated with treatment (Tx28) after 28 nights of usage.
•  Respiratory inductance plethysmography, nasal airflow cannula, oral airflow
thermistor, finger oximeter, video body position
•  PSG scored blindly using AASM recommended criteria by one scorer
Symptomatic measures: Epworth Sleepiness Scale (ESS) and a modified Functional
Outcomes of Sleep Questionnaire (mFOSQ)
•  Sub-analysis by use of prior OSA treatment at time of baseline symptom measurement
Subjects’ opinion of therapy scored on Likert scale.
Usage recorded objectively by console
Analysis cohort had total sleep time (TST) > 4 hours at baseline and Tx1
Sub-analysis cohort using prospectively defined clinical success criteria of AHI reduction
(Tx1 vs baseline) ≥50% and Tx1 AHI ≤20
Statistics: paired t-test and signed rank test
RESULTS CONCLUSIONS: Oral pressure therapy was safe in all subjects. Clinically significant improvement in AHI and symptomatic measures
were achieved in an easily identified sub-group. Nightly usage was high in frequency and duration and subjects indicated preference
for this system over alternatives for treatment of OSA. OPT shows promise as a new, well tolerated non-invasive therapy for OSA.
RESEARCH FUNDING SOURCE: ApniCure, Inc.
Am J Respir Crit Care Med 2012;185:A6810.
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15 Oral Pressure Therapy (OPT) is a novel approach to treating obstructive sleep apnea
(OSA).
The OPT system (WinxTM, ApniCure, Inc., Redwood City, CA) comprises a bedside
console, a soft polymer mouthpiece, and a flexible tube connecting the mouthpiece to
the console. The console creates vacuum pulling the soft palate anteriorly and
stabilizing the tongue to reduce obstruction during sleep.
This study examined the safety, effectiveness, and tolerability of this system.
* Natural breathing through the nose
Natural seal of soft palate
against tongue isolates
airway from oral cavity
Tongue
Oral vacuum
Mouthpiece
* 14.7 14.8 10 RESEARCH POSTER PRESENTATION DESIGN © 2012
www.PosterPresentations.com
Control Tx1 AHI BY BASELINE SEVERITY FOR CLINICAL SUCCESS CRITERIA COHORT (N=25)
Control Tx1 10.7 5.3 3.4 * 9.4 Moderate (n=9) Severe (n=12) EPWORTH SLEEPINESS SCALE (ESS) 13.5 6 7 On Treatment Prior (n=17) Tx28 MODIFIED FUNCTIONAL OUTCOME OF SLEEP QUESTIONNAIRE (mFOSQ)
20 17.6 18 16 * 18.2 18.5 15.5 Moderate (n=17) Severe (n=30) Stage 1 shifts
12.4±6.2
9.6±4.5*
8.8±4.7*
Stage shifts
33.8±11.9
27.9±9.1*
26.6±10.8*
Awakenings
44.4±23.8
37.8±16.1*
34.2±16.9*
Arousal index
43.9±17.8
33.1±15.9*
32.0±13.0*
Sleep efficiency (% TST)
79.6±9.3
78.8±8.8
83.4±7.9*
WASO (min)
75.0±41.4
77.7±39.7
60.5±36.7*
% TST in stage 1
27.8±18.1
21.9±12.5*
21.7±13.5*
%TST in stage 2
49.0±12.6
50.9±11.5
52.2±12.4*
%TST in stage 3
7.2±7.1
8.9±8.5
7.9±6.4
%TST in REM
16.0±7.1
18.3±6.6*
18.1±7.0
% TST supine
61.2±35.8
69.1±32.0*
68.8±32.6*
Control
Tx 1
Tx 28
25
25
20
Stage 1 shifts
12.1±5.4
7.7±3.0*
6.8±3.1*
Stage shifts
33.9±11.2
24.4±5.6*
22.6±7.3*
Awakenings
42.3±17.5
32.8±12.0*
25.5±10.7*
Arousal index
43.6±17.5
23.0±11.0*
26.8±10.8*
Sleep efficiency (% TST)
82.0±8.1
80.6±8.7
86.8±6.8*
WASO (min)
66.1±35.1
71.2±39.9
49.1±33.9*
% TST in stage 1
25.9±12.7
17.6±10.5*
16.5±9.5*
%TST in stage 2
51.7±9.4
52.9±10.2
54.9±8.1*
%TST in stage 3
6.8±6.1
10.2±7.9*
9.6±6.0
%TST in REM
15.7±6.0
19.2±6.1*
19.0±5.4*
% TST supine
59.2±37.5
57.9±36.4
63.0±35.0
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Median usage per night was 6.0 hours.
Median % of nights with more than 4 hours of usage was 87.5%.
79% of subjects agreed with the statement, “I would use the system to treat my sleep
apnea.”
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No serious device-related adverse events or unanticipated adverse device effects
5 subjects withdrew before completing 28 nights of treatment
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3 due to oral tissue discomfort and irritation
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2 due to high AHI with inadequate therapeutic response
CONCLUSIONS AHI, ODI, symptomatic measures, and sleep architecture were significantly improved by OPT.
Nightly usage was high in frequency and duration and subjects indicated interest in using OPT
to treat their OSA. Response to OPT is easily evaluated in individuals. OPT is a new, safe, well
tolerated non-invasive therapy for OSA in appropriate patients.
ACKNOWLEDGEMENTS 14 Mild (n=13) 50
SAFETY (analysis cohort)
51.0 14 60
COMPLIANCE (analysis cohort)
* 8 Control 22.4 23.8 22.1 * 9.1 * Off Treatment Prior (n=38) * 60
21.2 0 * Tx 28
n
5 Tx28 Tx 1
SLEEP ARCHITECTURE FOR CLINICAL SUCCESS CRITERIA COHORT (N=25)
45.6 10 ODI (/hr, 4%) Control
mean±SD, * p<0.05 paired t-test
SYMPTOMATIC MEASURES IN ANALYSIS COHORT
0 © ApniCure, Inc., reproduced with permission
ODI median values, * p<0.05 signed rank test vs control
AHI at Tx1 was ≤10 in 20 subjects (median 4.9)
15 AHI BY BASELINE SEVERITY
8.5 7.6 5.8 0 AHI * 12.1 12.5 40 10 0 * 15 median values
•  p<0.05 signed rank test vs control
20 4.7 5 Mild (n=4) AHI (/hr) 30 * 0.0 0 0 * 5.3 5 10.0 24.4 5 5 10 10 20.0 10 50 Airway
15 20 60 Soft palate
20 30.0 25 25 20 INTRODUCTION • 
30 15 40.0 30 31 SLEEP ARCHITECTURE IN ANALYSIS COHORT
n
25 50.0 SUBJECTS (analysis cohort)
•  60 subjects (43 male)
•  BMI 32.1±4.5 kg/m2 (mean±SD)
•  age 53.6±9.0 years (range 32-80)
35 30 CLINICAL SUCCESS CRITERIA COHORT (N=25)
18.7 20 28 Off Treatment Prior (n=38) On Treatment Prior (n=17) This study was sponsored by ApniCure, Inc.