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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03372070
Other study ID # SOM-026
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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