Continuous Negative External Pressure for the Treatment of Primary Snoring

N/AWithdrawnNCT03372070

Sommetrics, Inc.

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Snoring

Interventions

cNEPDEVICE

soft silicon collar applied to anterior neck with negative pressure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

change in snoring duration

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

Time frame: two weeks after initiation of treatment

Secondary Outcomes

change in apnea-hypopnea index (AHI)

mean AHI compared to baseline

Time frame: two weeks after initiation of treatment

change in snoring intensity

mean dBC compared to baseline

Time frame: two weeks after initiation of treatment

Treatment-emergent adverse events

tabulation of all adverse events during the clinical trial

Time frame: two weeks

change in Epworth Sleepiness Scale (ESS)

mean ESS compared to baseline (total range 0-24; lower score means less sleepy)

Time frame: two weeks after initiation of treatment

Short Form Survey 36 (SF-36)

mean SF-36 compared to baseline

Time frame: 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"

Time frame: 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"

Data from ClinicalTrials.gov

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