SnoringNCT02767843
Pilot Study of cNEP for the Treatment of Snoring
A study testing continuous negative external pressure (cNEP) in people with Snoring, run by Sommetrics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Snoring
- What is being tested?
- continuous negative external pressure (cNEP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 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
Who cannot join
- previous neck surgery or radiation
- carotid artery disease
- serious medical or psychiatric illness
- pregnancy
- silicone allergy
- excessive use of alcohol or sedating drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
California Center for Sleep Disorders
Alameda, California, 94501
About this study
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
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.
- Conditions
- Snoring
- Being tested
- continuous negative external pressure (cNEP)
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous negative external pressure (cNEP)Device
soft silicone collar placed on the anterior neck, to which a negative pressure is introduced
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | continuous negative external pressure (cNEP) at various negative pressures Receives: Device: continuous negative external pressure (cNEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
snoring decreased by <50% from baseline
Measured: one night
Adverse Events
all adverse events
Measured: one night
Secondary outcomes (1)
Complete Response
snoring for < 5% of total sleep tim
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionDec 2016
Why it stopped: Recruiting sufficient number of qualified subjects proved impossible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sommetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerrold Kram, MD, Principal investigator, California Center for Sleep Disorders, Alameda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767843
- Sponsor's protocol ID
- SOM-011
- Status last verified
- Apr 2024
- First submitted
- 9 May 2016
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02767843
- Acronym / sponsor ID
- SOM-011
- Conditions
- Snoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting sufficient number of qualified subjects proved impossible.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sommetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: continuous negative external pressure (cNEP)continuous negative external pressure (cNEP) at various negative pressures |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- previous neck surgery or radiation
- carotid artery disease
- serious medical or psychiatric illness
- pregnancy
- silicone allergy
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 |
|---|---|---|
| continuous negative external pressure (cNEP)soft silicone collar placed on the anterior neck, to which a negative pressure is introduced | Device | treatment |
Primary outcome
Response
Time frame: one night
snoring decreased by <50% from baseline
Adverse Events
Time frame: one night
all adverse events
1 secondary outcome
Complete Response
Time frame: one night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jerrold Kram, MD principal investigator
California Center for Sleep Disorders, Alameda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous negative external pressure (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?
The sponsor lists 2 inclusion and 6 exclusion criteria. 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: stopped early, as of the sponsor's last update on 7 May 2024. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response (time frame: one night). The study lists 2 primary outcomes in all. 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 7 May 2024.