SnoringNCT03372070
Continuous Negative External Pressure for the Treatment of Primary Snoring
A study testing cNEP in people with Snoring, run by Sommetrics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Snoring
- What is being tested?
- cNEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Snoring
- Being tested
- cNEP
- Keywords
- primary snoring, bed partner, home sleep testing
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cNEPDevice
Also called continuous negative external pressure
soft silicon collar applied to anterior neck with negative pressure
| Study group | Role | What they receive |
|---|---|---|
| cNEP | Experimental | silicone collar applied to anterior neck Receives: Device: cNEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in snoring duration
duration of snoring as a percent of total sleep time compared to baseline
Measured: two weeks after initiation of treatment
Secondary outcomes (11)
change in apnea-hypopnea index (AHI)
mean AHI compared to baseline
Measured: two weeks after initiation of treatment
change in snoring intensity
mean dBC compared to baseline
Measured: two weeks after initiation of treatment
Treatment-emergent adverse events
tabulation of all adverse events during the clinical trial
Measured: two weeks
change in Epworth Sleepiness Scale (ESS)
mean ESS compared to baseline (total range 0-24; lower score means less sleepy)
Measured: two weeks after initiation of treatment
Short Form Survey 36 (SF-36)
mean SF-36 compared to baseline
Measured: one week time frame, administered two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Snorer's sleep
CGI "usual sleep score" vs baseline (score range "very much better to very much worse"
Measured: previous week, assessed one and two weeks after initiation of treatment
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"
Measured: previous week, assessed one and two weeks after initiation of treatment
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"
Measured: "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
CGI scale comparing snorer's sleep to baseline (score range "very much better to very much worse"
Measured: previous week, assessed one and two weeks after initiation of treatment
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"
Measured: previous week, assessed one and two weeks after initiation of treatment
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"
Measured: previous week, assessed one and two weeks after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sommetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reena Mehra, MD, Principal investigator, Cleveland Clinic Lerner College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372070
- Sponsor's protocol ID
- SOM-026
- Status last verified
- Sep 2019
- First submitted
- 8 Dec 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Negative External Pressure (cNEP) for the Treatment of Primary Snoring: A Pilot Study
- ClinicalTrials.gov ID
- NCT03372070
- Acronym / sponsor ID
- SOM-026
- Conditions
- Snoring
- Keywords
- primary snoring, bed partner, home sleep testing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sommetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cNEP | Experimental | Device: cNEPsilicone collar applied to anterior neck |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cNEPAlso: continuous negative external pressuresoft silicon collar applied to anterior neck with negative pressure | Device | cNEP |
Primary outcome
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
11 secondary outcomes
change in apnea-hypopnea index (AHI)
Time frame: two weeks after initiation of treatment
change in snoring intensity
Time frame: two weeks after initiation of treatment
Treatment-emergent adverse events
Time frame: two weeks
change in Epworth Sleepiness Scale (ESS)
Time frame: 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
Clinical Global Impression (CGI) Scale: Snorer's sleep
Time frame: 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
Clinical Global Impression (CGI) Scale: Acceptability of cNEP
Time frame: "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
Clinical Global Impression (CGI) Scales: bed partner's sleep
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reena Mehra, MD principal investigator
Cleveland Clinic Lerner College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cNEP in people with Snoring, run by Sommetrics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in snoring duration (time frame: two weeks after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.