Continuous Negative External Pressure for the Treatment of Primary Snoring

NCT ID: NCT03372070

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2023-01-31

Brief Summary

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.

Conditions

Snoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cNEP

silicone collar applied to anterior neck

Group Type: EXPERIMENTAL

cNEP

Intervention Type: DEVICE

soft silicon collar applied to anterior neck with negative pressure

Interventions

cNEP

soft silicon collar applied to anterior neck with negative pressure

Intervention Type: DEVICE

Other Intervention Names

continuous negative external pressure

Eligibility Criteria

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

• 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

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

-known sleep disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sommetrics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reena Mehra, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Lerner College of Medicine

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

SOM-026

Identifier Type: -

Identifier Source: org_study_id