Continuous Negative External Pressure for the Treatment of Primary Snoring

Snoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03372070
• Other study ID #: SOM-026
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: January 2023

Study information

• Verified date: September 2019
• Source: Sommetrics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Snoring

Intervention

Device:
• cNEP
soft silicon collar applied to anterior neck with negative pressure

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sommetrics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in snoring duration	duration of snoring as a percent of total sleep time compared to baseline	two weeks after initiation of treatment
Secondary	change in apnea-hypopnea index (AHI)	mean AHI compared to baseline	two weeks after initiation of treatment
Secondary	change in snoring intensity	mean dBC compared to baseline	two weeks after initiation of treatment
Secondary	Treatment-emergent adverse events	tabulation of all adverse events during the clinical trial	two weeks
Secondary	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
Secondary	Short Form Survey 36 (SF-36)	mean SF-36 compared to baseline	one week time frame, administered two weeks after initiation of treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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