Snoring
Conditions
Brief 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.
Interventions
DEVICEcontinuous negative external pressure (cNEP)
soft silicone collar placed on the anterior neck, to which a negative pressure is introduced
Sponsors
Sommetrics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* previous neck surgery or radiation * carotid artery disease * serious medical or psychiatric illness * pregnancy * silicone allergy * excessive use of alcohol or sedating drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response | one night | snoring decreased by \<50% from baseline |
| Adverse Events | one night | all adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | one night | snoring for \< 5% of total sleep tim |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 42 years |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Adverse Events
all adverse events
Time frame: one night
Population: All four participants were analyzed for adverse events. No participants could be analyzed for efficacy outcomes because of technical difficulties with the measurement instruments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects | Adverse Events | 1 Participants |
Primary
Response
snoring decreased by \<50% from baseline
Time frame: one night
Population: Technical problems with the measurement instruments meant that no analyzable data were collected.
Secondary
Complete Response
snoring for \< 5% of total sleep tim
Time frame: one night
Population: Insufficient enrollment to permit analysis.