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Pilot Study of cNEP for the Treatment of Snoring

Not Applicable
Terminated
Conditions
Snoring
Registration Number
NCT02767843
Lead Sponsor
Sommetrics, Inc.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
4
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Adverse Eventsone night

all adverse events

Responseone night

snoring decreased by \<50% from baseline

Secondary Outcome Measures
NameTimeMethod
Complete Responseone night

snoring for \< 5% of total sleep tim

Trial Locations

Locations (1)

California Center for Sleep Disorders

🇺🇸

Alameda, California, United States

California Center for Sleep Disorders
🇺🇸Alameda, California, United States

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