OTC Mouthpiece for Snoring
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|ClinicalTrials.gov Identifier: NCT03128307|
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Snoring||Device: Zyppah Anti-snoring Appliance||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||604 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patient serves as their own control|
|Masking:||Double (Care Provider, Investigator)|
|Masking Description:||The data is compiled and analyzed by an outside, independent organization|
|Official Title:||In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers|
|Actual Study Start Date :||April 7, 2017|
|Actual Primary Completion Date :||May 3, 2017|
|Actual Study Completion Date :||August 10, 2017|
Device: Zyppah Anti-snoring Appliance
- Snoring Severity Scale [ Time Frame: Baseline and 10 Days ]
The Snoring Severity Scale (SSS) is a 9-point, validated scale to measure the severity of snoring. A total of three questions are asked: 1) "How often do you snore, 2) "How long do you snore", and 3) How audible is your snoring. Answers for each of these questions are summed for a total SSS score. A score of '0' would indicate no snoring at all, while a score of '9' would indicate the most severe snoring as measured by the SSS.
Outcome measure reported as change with use of the device over pre-trial. In this case, a negative ('-') would represent improvement in snoring symptoms, while a positive ('+') number would indicate an increase in snoring severity.
- Visual-Analogue Scale, Self-Reported Snoring Habits [ Time Frame: Baseline and 10 Days ]Quantitative assessment on 1-10 scale. Outcome measurement reported as a percentage change from pre-trial with use of the device. A negative ('-') percentage would indicate a reduction in snoring symptoms as measured by the VAS, while a positive percentage ('+') result would indicate an increase in the measured symptom.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128307
|United States, California|
|The EyeDeas Company|
|Lake Forest, California, United States, 92630|
|Principal Investigator:||Jonathan Greenburg, DDS||Zyppah, Inc.|