An interventional study of continuous negative external pressure (cNEP) in Snoring, sponsored by Sommetrics, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Sommetrics, Inc. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
continuous negative external pressure (cNEP) at various negative pressures
Device: continuous negative external pressure (cNEP)
soft silicone collar placed on the anterior neck, to which a negative pressure is introduced
Response
snoring decreased by \<50% from baseline
Time frame: one night
Adverse Events
all adverse events
Time frame: one night
Complete Response
snoring for \< 5% of total sleep tim
Time frame: one night
| Milestone | Subjects |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
snoring decreased by \<50% from baseline
No measurements were reported for this outcome.
all adverse events
| Participants | Subjects |
|---|---|
| Adverse Events | 1 |
snoring for \< 5% of total sleep tim
No measurements were reported for this outcome.
Collected over entire study duration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects | — | 0/4 (0%) | 1/4 (25%) |
| Event | All Subjects |
|---|---|
| minor erythemaSkin and subcutaneous tissue disorders | 1/4 |
all subjects who underwent cNEP usage
| Age, Categorical(Participants) | Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 42 (33 to 57) |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 3 |
| Male | 1 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| United States | 4 |
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Sommetrics, Inc.