Continuous Negative External Pressure for the Treatment of Primary Snoring

September 30, 2019 updated by: Sommetrics, Inc.

Continuous Negative External Pressure (cNEP) for the Treatment of Primary Snoring: A Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cNEP
silicone collar applied to anterior neck
Device: cNEP
soft silicon collar applied to anterior neck with negative pressure
Other Names:
  • continuous negative external pressure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in snoring duration
Time Frame: two weeks after initiation of treatment
duration of snoring as a percent of total sleep time compared to baseline
two weeks after initiation of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in apnea-hypopnea index (AHI)
Time Frame: two weeks after initiation of treatment
mean AHI compared to baseline
two weeks after initiation of treatment
change in snoring intensity
Time Frame: two weeks after initiation of treatment
mean dBC compared to baseline
two weeks after initiation of treatment
Treatment-emergent adverse events
Time Frame: two weeks
tabulation of all adverse events during the clinical trial
two weeks
change in Epworth Sleepiness Scale (ESS)
Time Frame: two weeks after initiation of treatment
mean ESS compared to baseline (total range 0-24; lower score means less sleepy)
two weeks after initiation of treatment
Short Form Survey 36 (SF-36)
Time Frame: one week time frame, administered two weeks after initiation of treatment
mean SF-36 compared to baseline
one week time frame, administered two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Snorer's sleep
Time Frame: previous week, assessed one and two weeks after initiation of treatment
CGI "usual sleep score" vs baseline (score range "very much better to very much worse"
previous week, assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Bed partner's complaints about snoring
Time Frame: previous week, assessed one and two weeks after initiation of treatment
CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more"
previous week, assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Acceptability of cNEP
Time Frame: "overall experience to date", assessed one and two weeks after initiation of treatment
CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more"
"overall experience to date", assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Bed partner's impression of snorer's sleep
Time Frame: previous week, assessed one and two weeks after initiation of treatment
CGI scale comparing snorer's sleep to baseline (score range "very much better to very much worse"
previous week, assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scales: bed partner's sleep
Time Frame: previous week, assessed one and two weeks after initiation of treatment
CGI scale comparing bed partner's sleep to baseline (score range "very much better to very much worse"
previous week, assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Bed partner's overall relationship with snorer
Time Frame: previous week, assessed one and two weeks after initiation of treatment
CGI scale comparing bed partner's overall relationship wtih snorer to baseline (score range "very much better to very much worse"
previous week, assessed one and two weeks after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sommetrics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reena Mehra, MD, Cleveland Clinic Lerner College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOM-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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