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

NCT03375905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-09-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

cNEP

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

Sponsors & Collaborators

  • Sommetrics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jamil S Sulieman, MD · The Sleep Lab, Kaneohe, HI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2019-03-28
Completion
2019-04-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03375905 on ClinicalTrials.gov