Continuous Negative External Pressure for the Treatment of Primary Snoring

NCT03372070 | Withdrawn FDA Device

• 1 other identifier: SOM-026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

primary snoring; bed partner; home sleep testing

Outcome Measures

Primary Outcomes (1)

• change in snoring duration

  duration of snoring as a percent of total sleep time compared to baseline

  two weeks after initiation of treatment

Secondary Outcomes (11)

• change in apnea-hypopnea index (AHI)

  two weeks after initiation of treatment

• change in snoring intensity

  two weeks after initiation of treatment

• Treatment-emergent adverse events

  two weeks

• change in Epworth Sleepiness Scale (ESS)

  two weeks after initiation of treatment

• Short Form Survey 36 (SF-36)

  one week time frame, administered two weeks after initiation of treatment

Study Arms (1)

cNEP

EXPERIMENTAL

silicone collar applied to anterior neck

Device: cNEP

Interventions

cNEP DEVICE

soft silicon collar applied to anterior neck with negative pressure

Also known as: continuous negative external pressure

cNEP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sommetrics, Inc.: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Reena Mehra, MD

  Cleveland Clinic Lerner College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

US (1)