Pilot Study of cNEP for the Treatment of Snoring

Sommetrics, Inc.4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Snoring

Interventions

continuous negative external pressure (cNEP)DEVICE

soft silicone collar placed on the anterior neck, to which a negative pressure is introduced

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

California Center for Sleep Disorders

Alameda, California, United States

Outcomes

Primary Outcomes

Response

snoring decreased by \<50% from baseline

Time frame: one night

Adverse Events

all adverse events

Time frame: one night

Secondary Outcomes

Complete Response

snoring for \< 5% of total sleep tim

Time frame: one night

Data from ClinicalTrials.gov

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