Back to resultsHome Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial
Primary Purpose
Obstructive Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continuous negative external pressure
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- must have completed study SOM-012 and been categorized as a "responder"
- the subject agrees to participation by signing an informed consent statement
Exclusion Criteria:
- 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
Sites / Locations
- California Center for Sleep Disorders
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cNEP
Arm Description
continuous negative external pressure will be used nightly by all participants
Outcomes
Primary Outcome Measures
Reduction in baseline apnea hypopnea index from baseline
Reduction in apnea hypopnea index (AHI) from the baseline value of >50% and also <15/hr
Secondary Outcome Measures
Collection of adverse events
Collection of adverse events
Apnea hypopnea index, as measured by home sleep testing
Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03108417
Brief Title
Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial
Official Title
Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be "Responders"
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no eligible subjects were available for recruitment
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sommetrics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cNEP
Arm Type
Experimental
Arm Description
continuous negative external pressure will be used nightly by all participants
Intervention Type
Device
Intervention Name(s)
continuous negative external pressure
Other Intervention Name(s)
cNEP
Intervention Description
continuous negative external pressure will be applied to the anterior neck at night
Primary Outcome Measure Information:
Title
Reduction in baseline apnea hypopnea index from baseline
Description
Reduction in apnea hypopnea index (AHI) from the baseline value of >50% and also <15/hr
Time Frame
End of Week 2 of home use
Secondary Outcome Measure Information:
Title
Collection of adverse events
Description
Collection of adverse events
Time Frame
two week study period
Title
Apnea hypopnea index, as measured by home sleep testing
Description
Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012
Time Frame
two weeks
Other Pre-specified Outcome Measures:
Title
Clinical global impression of cNEP experience
Description
Assessment of the tolerability of cNEP to the subject via a clinical global impression scale
Time Frame
end of week two of home use
Title
Bed partner's views of cNEP via a clinical global impression scale
Description
Determination of the bed partner's views of the subject using cNEP in the home setting using a clinical global impression scale
Time Frame
end of two weeks of home use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must have completed study SOM-012 and been categorized as a "responder"
the subject agrees to participation by signing an informed consent statement
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold Kram, MD
Organizational Affiliation
California Center for Sleep Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Center for Sleep Disorders
City
Alameda
State/Province
California
ZIP/Postal Code
94501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial
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