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Administrative reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cNEP | Experimental | silicone collar applied to anterior neck |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cNEP | Device | soft silicon collar applied to anterior neck with negative pressure |
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| Measure | Description | Time Frame |
|---|---|---|
| change in snoring duration | duration of snoring as a percent of total sleep time compared to baseline | two weeks after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| change in apnea-hypopnea index (AHI) | mean AHI compared to baseline | two weeks after initiation of treatment |
| change in snoring intensity | mean dBC compared to baseline |
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Key Snorer Inclusion Criteria:
Key bed partner Inclusion criteria
Key snorer exclusion criteria:
Key bed partner exclusion criteria:
-known sleep disorder
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| Name | Affiliation | Role |
|---|---|---|
| Reena Mehra, MD | Cleveland Clinic Lerner College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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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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| two weeks after initiation of treatment |
| Treatment-emergent adverse events | tabulation of all adverse events during the clinical trial | two weeks |
| change in Epworth Sleepiness Scale (ESS) | mean ESS compared to baseline (total range 0-24; lower score means less sleepy) | two weeks after initiation of treatment |
| Short Form Survey 36 (SF-36) | mean SF-36 compared to baseline | one week time frame, administered two weeks after initiation of treatment |
| Clinical Global Impression (CGI) Scale: Snorer's sleep | CGI "usual sleep score" vs baseline (score range "very much better to very much worse" | previous week, assessed one and two weeks after initiation of treatment |
| Clinical Global Impression (CGI) Scale: Bed partner's complaints about snoring | CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more" | previous week, assessed one and two weeks after initiation of treatment |
| Clinical Global Impression (CGI) Scale: Acceptability of cNEP | CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more" | "overall experience to date", assessed one and two weeks after initiation of treatment |
| Clinical Global Impression (CGI) Scale: Bed partner's impression of snorer's sleep | CGI scale comparing snorer's sleep to baseline (score range "very much better to very much worse" | previous week, assessed one and two weeks after initiation of treatment |
| Clinical Global Impression (CGI) Scales: bed partner's sleep | CGI scale comparing bed partner's sleep to baseline (score range "very much better to very much worse" | previous week, assessed one and two weeks after initiation of treatment |
| Clinical Global Impression (CGI) Scale: Bed partner's overall relationship with snorer | CGI scale comparing bed partner's overall relationship wtih snorer to baseline (score range "very much better to very much worse" | previous week, assessed one and two weeks after initiation of treatment |