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Recruiting sufficient number of qualified subjects proved impossible.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | continuous negative external pressure (cNEP) at various negative pressures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous negative external pressure (cNEP) | Device | soft silicone collar placed on the anterior neck, to which a negative pressure is introduced |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response | snoring decreased by <50% from baseline | one night |
| Adverse Events | all adverse events | one night |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | snoring for < 5% of total sleep tim | one night |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrold Kram, MD | California Center for Sleep Disorders, Alameda, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Center for Sleep Disorders | Alameda | California | 94501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects | Only four subjects completed the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all subjects who underwent cNEP usage
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | continuous negative external pressure (cNEP) at various negative pressures continuous negative external pressure (cNEP): soft silicone collar placed on the anterior neck, to which a negative pressure is introduced |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response | snoring decreased by <50% from baseline | Technical problems with the measurement instruments meant that no analyzable data were collected. | Posted | one night |
|
|
entire study duration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | Only four subjects completed the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | minor erythema, spontaneously resolved |
Early termination due to difficulty of recruitment. Technical problems with measurements, so data were uninterpretable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerrold Kram, MD | California Center for Sleep Disorders | 510.263.3300 | info@californiasleepcenters.com |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Adverse Events | all adverse events | All four participants were analyzed for adverse events. No participants could be analyzed for efficacy outcomes because of technical difficulties with the measurement instruments. | Posted | Count of Participants | Participants | one night |
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|
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| Secondary | Complete Response | snoring for < 5% of total sleep tim | Insufficient enrollment to permit analysis. | Posted | one night |
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| 0 |
| 4 |
| 1 |
| 4 |
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