Back to resultsPilot Study of cNEP for the Treatment of Snoring
Primary Purpose
Snoring
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continuous negative external pressure (cNEP)
Sponsored by
About this trial
This is an interventional treatment trial for Snoring
Eligibility Criteria
Inclusion Criteria:
- sleep test within the previous six months that shows snoring of at least 30 dB for at least 30% of total sleep time
- AHI < 10/hr
Exclusion Criteria:
- previous neck surgery or radiation
- carotid artery disease
- serious medical or psychiatric illness
- pregnancy
- silicone allergy
- excessive use of alcohol or sedating drugs
Sites / Locations
- California Center for Sleep Disorders
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
continuous negative external pressure (cNEP) at various negative pressures
Outcomes
Primary Outcome Measures
Response
snoring decreased by <50% from baseline
Adverse Events
all adverse events
Secondary Outcome Measures
Complete Response
snoring for < 5% of total sleep tim
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02767843
Brief Title
Pilot Study of cNEP for the Treatment of Snoring
Official Title
Pilot Study to Assess the Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Reducing Respiratory Sounds in Individuals With Chronic Snoring
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruiting sufficient number of qualified subjects proved impossible.
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sommetrics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will examine the efficacy and safety of continuous negative external pressure ("cNEP") for the treatment of chronic snoring in people without obstructive sleep apnea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
continuous negative external pressure (cNEP) at various negative pressures
Intervention Type
Device
Intervention Name(s)
continuous negative external pressure (cNEP)
Intervention Description
soft silicone collar placed on the anterior neck, to which a negative pressure is introduced
Primary Outcome Measure Information:
Title
Response
Description
snoring decreased by <50% from baseline
Time Frame
one night
Title
Adverse Events
Description
all adverse events
Time Frame
one night
Secondary Outcome Measure Information:
Title
Complete Response
Description
snoring for < 5% of total sleep tim
Time Frame
one night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
sleep test within the previous six months that shows snoring of at least 30 dB for at least 30% of total sleep time
AHI < 10/hr
Exclusion Criteria:
previous neck surgery or radiation
carotid artery disease
serious medical or psychiatric illness
pregnancy
silicone allergy
excessive use of alcohol or sedating drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold Kram, MD
Organizational Affiliation
California Center for Sleep Disorders, Alameda, CA
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
Pilot Study of cNEP for the Treatment of Snoring
We'll reach out to this number within 24 hrs