Continuous Negative External Pressure for the Treatment of Primary Snoring

Continuous Negative External Pressure (cNEP) for the Treatment of Primary Snoring: A Pilot Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Snoring
• Intervention / Treatment: Device: cNEP

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cNEP; silicone collar applied to anterior neck	Device: cNEP; soft silicon collar applied to anterior neck with negative pressure; Other Names: continuous negative external pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in snoring duration	duration of snoring as a percent of total sleep time compared to baseline	two weeks after initiation of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in apnea-hypopnea index (AHI)	mean AHI compared to baseline	two weeks after initiation of treatment
change in snoring intensity	mean dBC compared to baseline	two weeks after initiation of treatment
Treatment-emergent adverse events	tabulation of all adverse events during the clinical trial	two weeks
change in Epworth Sleepiness Scale (ESS)	mean ESS compared to baseline (total range 0-24; lower score means less sleepy)	two weeks after initiation of treatment
Short Form Survey 36 (SF-36)	mean SF-36 compared to baseline	one week time frame, administered two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Snorer's sleep	CGI "usual sleep score" vs baseline (score range "very much better to very much worse"	previous week, assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Bed partner's complaints about snoring	CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more"	previous week, assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Acceptability of cNEP	CGI "bed partner complaints about your snoring" scale vs baseline (score range "complained very much less, to "complained very much more"	"overall experience to date", assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Bed partner's impression of snorer's sleep	CGI scale comparing snorer's sleep to baseline (score range "very much better to very much worse"	previous week, assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scales: bed partner's sleep	CGI scale comparing bed partner's sleep to baseline (score range "very much better to very much worse"	previous week, assessed one and two weeks after initiation of treatment
Clinical Global Impression (CGI) Scale: Bed partner's overall relationship with snorer	CGI scale comparing bed partner's overall relationship wtih snorer to baseline (score range "very much better to very much worse"	previous week, assessed one and two weeks after initiation of treatment

Collaborators and Investigators

• Sponsor: Sommetrics, Inc.
• Investigators: Principal Investigator: Reena Mehra, MD, Cleveland Clinic Lerner College of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: primary snoring; bed partner; home sleep testing
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: SOM-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes