Snoring
Conditions
Keywords
primary snoring, bed partner, home sleep testing
Brief 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. 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.
Interventions
DEVICEcNEP
soft silicon collar applied to anterior neck with negative pressure
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in snoring duration | two weeks after initiation of treatment | duration of snoring as a percent of total sleep time compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in snoring intensity | two weeks after initiation of treatment | mean dBC compared to baseline |
| Treatment-emergent adverse events | two weeks | tabulation of all adverse events during the clinical trial |
| change in Epworth Sleepiness Scale (ESS) | two weeks after initiation of treatment | mean ESS compared to baseline (total range 0-24; lower score means less sleepy) |
| Short Form Survey 36 (SF-36) | one week time frame, administered two weeks after initiation of treatment | mean SF-36 compared to baseline |
| Clinical Global Impression (CGI) Scale: Snorer's sleep | previous week, assessed one and two weeks after initiation of treatment | CGI usual sleep score vs baseline (score range very much better to very much worse |
| change in apnea-hypopnea index (AHI) | two weeks after initiation of treatment | mean AHI compared to baseline |
| Clinical Global Impression (CGI) Scale: Acceptability of cNEP | overall experience to date, assessed one and two weeks after initiation of treatment | CGI bed partner complaints about your snoring scale vs baseline (score range complained very much less, to complained very much more |
| Clinical Global Impression (CGI) Scale: Bed partner's impression of snorer's sleep | previous week, assessed one and two weeks after initiation of treatment | CGI scale comparing snorer's sleep to baseline (score range very much better to very much worse |
| Clinical Global Impression (CGI) Scales: bed partner's sleep | previous week, assessed one and two weeks after initiation of treatment | CGI scale comparing bed partner's sleep to baseline (score range very much better to very much worse |
| Clinical Global Impression (CGI) Scale: Bed partner's overall relationship with snorer | previous week, assessed one and two weeks after initiation of treatment | CGI scale comparing bed partner's overall relationship wtih snorer to baseline (score range very much better to very much worse |
| Clinical Global Impression (CGI) Scale: Bed partner's complaints about snoring | previous week, assessed one and two weeks after initiation of treatment | CGI bed partner complaints about your snoring scale vs baseline (score range complained very much less, to complained very much more |
Countries
United States
Outcome results
None listed