Continuous Negative External Pressure for the Treatment of Primary Snoring

Not Applicable

Withdrawn

• Conditions: Snoring

• Registration Number: NCT03372070
• Lead Sponsor: Sommetrics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-13
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02
• Study Start: 2021-01
• Primary Completion: 2022-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change in snoring duration	two weeks after initiation of treatment	duration of snoring as a percent of total sleep time compared to baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States