Apnicure Winx, User Manual, Page: 56 / 60

50
TABLE 6: EPWORTH SLEEPINESS SCALE
Primary Endpoint Cohort ITT Cohort
Subgroup 1* Subgroup 2** Subgroup 1* Subgroup 2**
No. of Subjects 40 17 47 21
Baseline ESS 12.1 ± 5.1 9.4 ± 7.0 11.4 ± 5.2 9.5 ± 6.3
Day 28 ESS 8.6 ±5.2 8.5 ± 5.9 8.4 ± 5.0 8.2 ± 5.5
Change from Baseline -3.5 ± 4.6 -0.9 ± 2.9 -3.0 ± 4.4 -1.3 ± 2.7
p-value (t-test) <0.0001 0.1938 <0.0001 0.0428
* Subgroup 1: subjects were treatment naive or off OSA treatment two weeks prior to completing Baseline Sleep Questionnaire survey
** Subgroup 2: subjects were on OSA treatment time of Sleep Questionnaire survey
Values = mean ± standard deviation
Forty-seven ITT Cohort subjects that completed the ESS were treatment naïve or stopped using their OSA treatment at least two weeks prior to their
first visit, and therefore had untreated-baseline ESS scores (Subgroup 1). Twenty-two ITT Cohort subjects completed the ESS without stopping their
OSA treatment for two weeks, and therefore their baseline ESS scores reflected the results of prior treatment (Subgroup 2). One subject had missing
data thus was not included in the analysis. With treatment, improvement in ESS was seen in Subgroup 1 and maintenance of ESS was observed in
Subgroup 2. (See Table 6)
Compliance
Analysis of device usage compliance was performed using data recorded electronically by the console on the ITT Cohort that completed their 28-day
take home evaluation. In 69 subjects the median usage per day was 5.95 hours. The median percentage of days that subjects used the device for more
than 4 hours was 85.7%.
Safety
Safety data were obtained from 143 subjects in the ATLAST study. There were no serious device-related adverse events. None of the device-related
adverse events were rated as severe or progressed in severity with time or continued use. All adverse events resolved without medical intervention
(other than occasional OTC medications) and without consequence.
PN 12149-B.indd 50 4/23/13 11:53 AM