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NCT02767843 Clinical Trial

Pilot Study of cNEP for the Treatment of Snoring

Snoring Clinical Trial

Official title:
Pilot Study to Assess the Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Reducing Respiratory Sounds in Individuals With Chronic Snoring

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02767843
Other study ID # SOM-011
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date December 2016

Study information
Verified date April 2024
Source Sommetrics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• continuous negative external pressure (cNEP)
soft silicone collar placed on the anterior neck, to which a negative pressure is introduced

Locations
Country Name City State
United States California Center for Sleep Disorders Alameda California

Sponsors (1)
Lead Sponsor Collaborator
Sommetrics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response snoring decreased by <50% from baseline one night
Primary Adverse Events all adverse events one night
Secondary Complete Response snoring for < 5% of total sleep tim one night
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