Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea

Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03375905

Enrollment

Registered

2017-12-18

Start date

2017-12-07

Completion date

2019-04-26

Last updated

2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

ethnic Japanese

Brief summary

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.

Interventions

DEVICEcNEP

subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* both parents ethnically Japanese, or one parent Japanese and the other east-Asian * PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and \<80% of apneas and hypopneas are obstructive * cNEP collar fits and is well-tolerated Key

Exclusion criteria

* BMI \>34 * abnormalities in neck structure * sleep disturbance other than obstructive sleep apnea * serious medical illness * pregnancy

Design outcomes

Primary

Measure	Time frame	Description
proportion of sustained responders	two weeks after initiation of treatment	reduction of AHI of \>50% and to \<15/hr from qualifying PSG

Secondary

Measure	Time frame	Description
AHI comparison with qualifying PSG	one day, on three separate study occasions	apnea-hypopnea index
ODI comparison with qualifying PSG	one day, on three separate study occasions	oxygen desaturation index
SpO2 <90% comparison with qualifying PSG	one day, on three separate study occasions	oxygen desaturation index \<90%
proportion of initial responders	at PSG 1, one day	reduction of AHI of \>50% and to \<15/hr from qualifying PSG
CGI of satisfaction with the cNEP device	after two weeks of treatment	clinical global impressions of the cNEP device
Treatment-emergent adverse events	two weeks	tabulation of treatment-emergent adverse events
CGI of sleep	three months, and two weeks, respectively	clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026