Clinical trial NCT03372070: Continuous Negative External Pressure for the Treatment of Primary Snoring
Official title: Continuous Negative External Pressure (cNEP) for the Treatment of Primary Snoring: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Snoring
Keywords: primary snoring
bed partner
home sleep testing
Lead sponsor: Sommetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in snoring duration
timeFrame: two weeks after initiation of treatment
Secondary outcomes:
measure: change in apnea-hypopnea index (AHI)
timeFrame: two weeks after initiation of treatment
measure: change in snoring intensity
timeFrame: two weeks after initiation of treatment
measure: Treatment-emergent adverse events
timeFrame: two weeks
measure: change in Epworth Sleepiness Scale (ESS)
timeFrame: two weeks after initiation of treatment
measure: Short Form Survey 36 (SF-36)
timeFrame: one week time frame, administered two weeks after initiation of treatment
measure: Clinical Global Impression (CGI) Scale: Snorer's sleep
timeFrame: previous week, assessed one and two weeks after initiation of treatment
measure: Clinical Global Impression (CGI) Scale: Bed partner's complaints about snoring
timeFrame: previous week, assessed one and two weeks after initiation of treatment
measure: Clinical Global Impression (CGI) Scale: Acceptability of cNEP
timeFrame: "overall experience to date", assessed one and two weeks after initiation of treatment
measure: Clinical Global Impression (CGI) Scale: Bed partner's impression of snorer's sleep
timeFrame: previous week, assessed one and two weeks after initiation of treatment
measure: Clinical Global Impression (CGI) Scales: bed partner's sleep
timeFrame: previous week, assessed one and two weeks after initiation of treatment
measure: Clinical Global Impression (CGI) Scale: Bed partner's overall relationship with snorer
timeFrame: previous week, assessed one and two weeks after initiation of treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Cleveland Clinic Lerner College of Medicine
name: Reena Mehra, MD
role: PRINCIPAL_INVESTIGATOR
References: