Effectiveness and Safety of cNEP in Ethnic Japanese With... | NCT03375905

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

NCT03375905

Sponsor

Sommetrics, Inc.

Status

Completed

Last Update Posted

Sep 19, 2019Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

cNEP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 7, 2017Actual

Primary Completion Date

Mar 28, 2019Actual

Completion Date

Apr 26, 2019Actual

First Submitted Date

Dec 7, 2017

First Submission Date that Met QC Criteria

Dec 12, 2017

First Posted Date

Dec 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2019

Last Update Posted Date

Sep 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cNEP	Experimental	cNEP treatment	Device: cNEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cNEP	Device	subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas	cNEP

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
proportion of initial responders	reduction of AHI of >50% and to <15/hr from qualifying PSG	at PSG 1, one day
AHI comparison with qualifying PSG	apnea-hypopnea index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jamil S Sulieman, MD	The Sleep Lab, Kaneohe, HI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Sleep Lab		Kaneohe	Hawaii	96744	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided