The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
The Sleep Lab
Kaneohe, Hawaii, United States
proportion of sustained responders
reduction of AHI of \>50% and to \<15/hr from qualifying PSG
Time frame: two weeks after initiation of treatment
proportion of initial responders
reduction of AHI of \>50% and to \<15/hr from qualifying PSG
Time frame: at PSG 1, one day
AHI comparison with qualifying PSG
apnea-hypopnea index
Time frame: one day, on three separate study occasions
ODI comparison with qualifying PSG
oxygen desaturation index
Time frame: one day, on three separate study occasions
SpO2 <90% comparison with qualifying PSG
oxygen desaturation index \<90%
Time frame: one day, on three separate study occasions
CGI of sleep
clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment
Time frame: three months, and two weeks, respectively
CGI of satisfaction with the cNEP device
clinical global impressions of the cNEP device
Time frame: after two weeks of treatment
Treatment-emergent adverse events
tabulation of treatment-emergent adverse events
Time frame: two weeks
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