NCT03108417

Brief Summary

This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

March 25, 2017

Last Update Submit

November 15, 2017

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Reduction in baseline apnea hypopnea index from baseline

    Reduction in apnea hypopnea index (AHI) from the baseline value of \>50% and also \<15/hr

    End of Week 2 of home use

Secondary Outcomes (2)

  • Collection of adverse events

    two week study period

  • Apnea hypopnea index, as measured by home sleep testing

    two weeks

Other Outcomes (2)

  • Clinical global impression of cNEP experience

    end of week two of home use

  • Bed partner's views of cNEP via a clinical global impression scale

    end of two weeks of home use

Study Arms (1)

cNEP

EXPERIMENTAL

continuous negative external pressure will be used nightly by all participants

Device: continuous negative external pressure

Interventions

continuous negative external pressureDEVICE

continuous negative external pressure will be applied to the anterior neck at night

Also known as: cNEP
cNEP

Eligibility Criteria

Age22 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must have completed study SOM-012 and been categorized as a "responder"
  • the subject agrees to participation by signing an informed consent statement

You may not qualify if:

  • medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Center for Sleep Disorders

Alameda, California, 94501, 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

  • Jerrold Kram, MD

    California Center for Sleep Disorders

    PRINCIPAL INVESTIGATOR
0

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

March 25, 2017

First Posted

April 11, 2017

Study Start

October 1, 2017

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

US(1)