Continuous Negative External Pressure for the Treatment of Primary Snoring

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Negative External Pressure (cNEP) for the Treatment of Primary Snoring: A Pilot Study

Conditions
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Snoring

Intervention / Treatment
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* Device: cNEP


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria: -known sleep disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cNEP<br>silicone collar applied to anterior neck | Device: cNEP<br>* soft silicon collar applied to anterior neck with negative pressure<br>* Other names: continuous negative external pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary snoring, bed partner, home sleep testing