Continuous Negative External Pressure for the Treatment of Primary Snoring

Sommetrics

Status: Withdrawn

Conditions: Snoring

Treatments: Device: cNEP

Study type: Interventional

Funder types: Industry

Identifiers

NCT03372070

SOM-026

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Snorer Inclusion Criteria:

• BMI <35
• if a previously done polysomnogram (PSG) is available, AHI<5
• snoring identified by a previous PSG and/or by the bed partner

Key bed partner Inclusion criteria

• must have regularly slept with the snorer over the previous month and must plan to sleep with the snorer for the duration of the trial
• considers that the snorer's snoring is a problem
• must discontinue use of any snore-masking equipment or ear plug for at least two weeks prior to the initial visit to the study site and agree to refrain from their use for the duration of the trial

Key snorer exclusion criteria:

• sleep disturbance other than snoring
• snoring due primarily to abnormality of the nasopharynx
• use of snoring treatment during the month prior to the initial visit
• neck anatomic or skin abnormalities
• serious medical condition
• excessive drug or alcohol intake

Key bed partner exclusion criteria:

-known sleep disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

cNEP

Experimental group

Description:

silicone collar applied to anterior neck

Treatment:

Device: cNEP