NCT03375905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

December 7, 2017

Last Update Submit

September 17, 2019

Conditions

Obstructive Sleep Apnea

Keywords

ethnic Japanese

Outcome Measures

Primary Outcomes (1)

  • proportion of sustained responders

    reduction of AHI of \>50% and to \<15/hr from qualifying PSG

    two weeks after initiation of treatment

Secondary Outcomes (7)

  • proportion of initial responders

    at PSG 1, one day

  • AHI comparison with qualifying PSG

    one day, on three separate study occasions

  • ODI comparison with qualifying PSG

    one day, on three separate study occasions

  • SpO2 <90% comparison with qualifying PSG

    one day, on three separate study occasions

  • CGI of sleep

    three months, and two weeks, respectively

  • +2 more secondary outcomes

Study Arms (1)

cNEP

EXPERIMENTAL

cNEP treatment

Device: cNEP

Interventions

cNEPDEVICE

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

Also known as: continuous negative external pressure
cNEP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sleep Lab

Kaneohe, Hawaii, 96744, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jamil S Sulieman, MD

    The Sleep Lab, Kaneohe, HI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 18, 2017

Study Start

December 7, 2017

Primary Completion

March 28, 2019

Study Completion

April 26, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

US(1)