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

September 17, 2019 updated by: Sommetrics, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Kaneohe, Hawaii, United States, 96744
        • The Sleep Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cNEP
cNEP treatment
Device: cNEP
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
Other Names:
  • continuous negative external pressure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sommetrics, Inc.

Investigators

  • Principal Investigator: Jamil S Sulieman, MD, The Sleep Lab, Kaneohe, HI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2017

Primary Completion (Actual)

March 28, 2019

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOM-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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