Status:
WITHDRAWN
Continuous Negative External Pressure for the Treatment of Primary Snoring
Lead Sponsor:
Sommetrics, Inc.
Conditions:
Snoring
Eligibility:
All Genders
18-70 years
Phase:
NA
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 redu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03372070
Start Date
January 1 2021
End Date
January 1 2023
Last Update
October 2 2019
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195