An interventional study of cNEP in Snoring, sponsored by Sommetrics, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by Sommetrics, Inc. · Not applicable, Interventional, and Treatment
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.
Key Snorer Inclusion Criteria:
Key bed partner Inclusion criteria
Key snorer exclusion criteria:
Key bed partner exclusion criteria:
-known sleep disorder
silicone collar applied to anterior neck
Device: cNEP
soft silicon collar applied to anterior neck with negative pressure
Also known as: continuous negative external pressure
change in snoring duration
duration of snoring as a percent of total sleep time compared to baseline
Time frame: two weeks after initiation of treatment
change in apnea-hypopnea index (AHI)
mean AHI compared to baseline
Time frame: two weeks after initiation of treatment
change in snoring intensity
mean dBC compared to baseline
Time frame: two weeks after initiation of treatment
Treatment-emergent adverse events
tabulation of all adverse events during the clinical trial
Time frame: two weeks
change in Epworth Sleepiness Scale (ESS)
mean ESS compared to baseline (total range 0-24; lower score means less sleepy)
Time frame: two weeks after initiation of treatment
Short Form Survey 36 (SF-36)
mean SF-36 compared to baseline
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: "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"
Time frame: 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"
Time frame: 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"
Time frame: previous week, assessed one and two weeks after initiation of treatment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Sommetrics, Inc.