Pilot Study of cNEP for the Treatment of Snoring

Sommetrics

Status: Terminated

Conditions: Snoring

Treatments: Device: continuous negative external pressure (cNEP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02767843

SOM-011

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

treatment

Experimental group

Description:

continuous negative external pressure (cNEP) at various negative pressures

Treatment:

Device: continuous negative external pressure (cNEP)