Back to resultsContinuous Negative External Pressure for the Treatment of Primary Snoring
Primary Purpose
Snoring
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cNEP
Sponsored by
About this trial
This is an interventional treatment trial for Snoring focused on measuring primary snoring, bed partner, home sleep testing
Eligibility Criteria
Key Snorer Inclusion Criteria:
- BMI <35
- if a previously done polysomnogram (PSG) is available, AHI<5
- snoring identified by a previous PSG and/or by the bed partner
Key bed partner Inclusion criteria
- must have regularly slept with the snorer over the previous month and must plan to sleep with the snorer for the duration of the trial
- considers that the snorer's snoring is a problem
- must discontinue use of any snore-masking equipment or ear plug for at least two weeks prior to the initial visit to the study site and agree to refrain from their use for the duration of the trial
Key snorer exclusion criteria:
- sleep disturbance other than snoring
- snoring due primarily to abnormality of the nasopharynx
- use of snoring treatment during the month prior to the initial visit
- neck anatomic or skin abnormalities
- serious medical condition
- excessive drug or alcohol intake
Key bed partner exclusion criteria:
-known sleep disorder
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cNEP
Arm Description
silicone collar applied to anterior neck
Outcomes
Primary Outcome Measures
change in snoring duration
duration of snoring as a percent of total sleep time compared to baseline
Secondary Outcome Measures
change in apnea-hypopnea index (AHI)
mean AHI compared to baseline
change in snoring intensity
mean dBC compared to baseline
Treatment-emergent adverse events
tabulation of all adverse events during the clinical trial
change in Epworth Sleepiness Scale (ESS)
mean ESS compared to baseline (total range 0-24; lower score means less sleepy)
Short Form Survey 36 (SF-36)
mean SF-36 compared to baseline
Clinical Global Impression (CGI) Scale: Snorer's sleep
CGI "usual sleep score" vs baseline (score range "very much better to very much worse"
Clinical Global Impression (CGI) Scale: Bed partner's complaints about snoring
CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more"
Clinical Global Impression (CGI) Scale: Acceptability of cNEP
CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more"
Clinical Global Impression (CGI) Scale: Bed partner's impression of snorer's sleep
CGI scale comparing snorer's sleep to baseline (score range "very much better to very much worse"
Clinical Global Impression (CGI) Scales: bed partner's sleep
CGI scale comparing bed partner's sleep to baseline (score range "very much better to very much worse"
Clinical Global Impression (CGI) Scale: Bed partner's overall relationship with snorer
CGI scale comparing bed partner's overall relationship wtih snorer to baseline (score range "very much better to very much worse"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03372070
Brief Title
Continuous Negative External Pressure for the Treatment of Primary Snoring
Official Title
Continuous Negative External Pressure (cNEP) for the Treatment of Primary Snoring: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative reasons
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2023 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this pilot study is to gain information on the ability of a continuous negative external pressure collar to safely reduce snoring in primary snorers, and if so to determine whether the reduction in snoring has benefits for both the snorer and the bed partner. This clinical trial will involve both the snorer and his or her bed partner, both of whom must qualify and provide informed consent for participation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
Keywords
primary snoring, bed partner, home sleep testing
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
silicone collar applied to anterior neck
Intervention Type
Device
Intervention Name(s)
cNEP
Other Intervention Name(s)
continuous negative external pressure
Intervention Description
soft silicon collar applied to anterior neck with negative pressure
Primary Outcome Measure Information:
Title
change in snoring duration
Description
duration of snoring as a percent of total sleep time compared to baseline
Time Frame
two weeks after initiation of treatment
Secondary Outcome Measure Information:
Title
change in apnea-hypopnea index (AHI)
Description
mean AHI compared to baseline
Time Frame
two weeks after initiation of treatment
Title
change in snoring intensity
Description
mean dBC compared to baseline
Time Frame
two weeks after initiation of treatment
Title
Treatment-emergent adverse events
Description
tabulation of all adverse events during the clinical trial
Time Frame
two weeks
Title
change in Epworth Sleepiness Scale (ESS)
Description
mean ESS compared to baseline (total range 0-24; lower score means less sleepy)
Time Frame
two weeks after initiation of treatment
Title
Short Form Survey 36 (SF-36)
Description
mean SF-36 compared to baseline
Time Frame
one week time frame, administered two weeks after initiation of treatment
Title
Clinical Global Impression (CGI) Scale: Snorer's sleep
Description
CGI "usual sleep score" vs baseline (score range "very much better to very much worse"
Time Frame
previous week, assessed one and two weeks after initiation of treatment
Title
Clinical Global Impression (CGI) Scale: Bed partner's complaints about snoring
Description
CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more"
Time Frame
previous week, assessed one and two weeks after initiation of treatment
Title
Clinical Global Impression (CGI) Scale: Acceptability of cNEP
Description
CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more"
Time Frame
"overall experience to date", assessed one and two weeks after initiation of treatment
Title
Clinical Global Impression (CGI) Scale: Bed partner's impression of snorer's sleep
Description
CGI scale comparing snorer's sleep to baseline (score range "very much better to very much worse"
Time Frame
previous week, assessed one and two weeks after initiation of treatment
Title
Clinical Global Impression (CGI) Scales: bed partner's sleep
Description
CGI scale comparing bed partner's sleep to baseline (score range "very much better to very much worse"
Time Frame
previous week, assessed one and two weeks after initiation of treatment
Title
Clinical Global Impression (CGI) Scale: Bed partner's overall relationship with snorer
Description
CGI scale comparing bed partner's overall relationship wtih snorer to baseline (score range "very much better to very much worse"
Time Frame
previous week, assessed one and two weeks after initiation of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Snorer Inclusion Criteria:
BMI <35
if a previously done polysomnogram (PSG) is available, AHI<5
snoring identified by a previous PSG and/or by the bed partner
Key bed partner Inclusion criteria
must have regularly slept with the snorer over the previous month and must plan to sleep with the snorer for the duration of the trial
considers that the snorer's snoring is a problem
must discontinue use of any snore-masking equipment or ear plug for at least two weeks prior to the initial visit to the study site and agree to refrain from their use for the duration of the trial
Key snorer exclusion criteria:
sleep disturbance other than snoring
snoring due primarily to abnormality of the nasopharynx
use of snoring treatment during the month prior to the initial visit
neck anatomic or skin abnormalities
serious medical condition
excessive drug or alcohol intake
Key bed partner exclusion criteria:
-known sleep disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reena Mehra, MD
Organizational Affiliation
Cleveland Clinic Lerner College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Continuous Negative External Pressure for the Treatment of Primary Snoring
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